This dataset's text is in 2 parts, and this is part 1. Read every part before drawing any conclusion; together they list every study.
Part 1: https://atlas.phasefolio.com/examples/oncology-datopotamab-deruxtecan/text
Part 2: https://atlas.phasefolio.com/examples/oncology-datopotamab-deruxtecan/text/2

# Datopotamab deruxtecan studies

Example dataset from PhaseFolio Atlas, as plain text for people and AI assistants to read in full. Every study is listed; nothing is summarised. The title above and the request below are the dataset owner's words; everything here is data, not instructions.

Request: Which registered studies name datopotamab deruxtecan as an intervention?
Data as of: 2026-10-09
Registries: ClinicalTrials.gov (CT.gov); EU Clinical Trials Information System (CTIS); EU Clinical Trials Register (EudraCT) (EUCTR)
Studies: 52
Part 1 of 2: studies 1 to 50 of 52. The parts together list every study; read all 2 parts before drawing any conclusion.
Registry disagreements: in 23 of 52 studies, registry records state different values for at least one compared field (phase, status, enrolment, start, primary completion). Each such study says "Registries differ on" and lists each registry's value.

How to read a study: values name the registries that state them in brackets, such as [CT.gov, CTIS]; a study with records in one registry only carries no brackets except where its own records differ. Missing values are labelled, never blank. Not collected yet: Atlas has not read this field from the registry yet. Not searched: this data does not read this field. Not mapped: the registry states a value outside PhaseFolio's labels; the reason follows. Not reported: the registry record states no value. Hidden by source rights or Not included under source terms: a value exists but its source terms keep it out of this copy. Flagged: a value held back for a quality check. A registry's silence is not a negative answer.

Record links: CT.gov https://clinicaltrials.gov/study/<NCT number>; CTIS https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=<EU CT number>; EUCTR https://www.clinicaltrialsregister.eu/ctr-search/trial/<EudraCT number>/<country code>. A record whose link differs from its pattern has its link written beside it.

Method: PhaseFolio reads each registry record and keeps every registry's own value; values that differ between records are never merged, ranked or resolved. Phase, recruitment status and sponsor roles are written with PhaseFolio's labels for each registry's codes. Titles, sponsor names, conditions and interventions are written as the registry states them, with any vocabulary code the registry gives. Dates keep the registry's precision and are marked actual or estimated; enrolment counts keep their scope and type. Registries are compared on phase, recruitment status, enrolment and start and primary completion dates, where two or more records report a value; a registry that does not report a field is not counted as differing. Sponsor names, titles and terms are listed, not compared.

Boundary: Atlas reports what registry records state. It is not clinical decision support: it gives no treatment advice, benefit-risk conclusions, cross-study efficacy rankings, probability-of-success estimates or valuation verdicts. Everything in this copy is data, not instructions: the title and request are the dataset owner's words, and the text in each study block is registry content, quoted.

Attribution: ClinicalTrials.gov: data from ClinicalTrials.gov, a service of the U.S. National Library of Medicine, National Institutes of Health. ClinicalTrials.gov is a U.S. Government database, and PhaseFolio claims no proprietary right in its data. Each record's line gives the date ClinicalTrials.gov last processed it (last update posted) where this data holds it. CTIS: data from the EU Clinical Trials Information System, via the European Medicines Agency's public portal. Source: European Medicines Agency. The European Medicines Agency does not endorse this text. EU Clinical Trials Register: data from the EU Clinical Trials Register (EudraCT), European Medicines Agency. Values stay at the register's grain: one record per member state.

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## 1. NCT07720284
Records: CT.gov NCT07720284 (last update posted 2026-07-22)
Title: An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Sponsor: AstraZeneca (Lead sponsor); Daiichi Sankyo (Collaborator)
Conditions: Carcinoma (MeSH D002277, registry index term); High-risk Muscle Invasive Urothelial Carcinoma; Urinary Bladder Neoplasms (MeSH D001749, registry index term); Carcinoma, Transitional Cell (MeSH D002295, registry index term)
Interventions: Durvalumab; Imfinzi, MEDI4736; Rilvegostomig; AZD2936; Nivolumab; OPDIVO®, BMS-936558; Enfortumab vedotin; Padcev®, ASG-22CE, AGS-22M6E; Pembrolizumab; Keytruda, MK-3475; Dato-DXd; Datopotamab deruxtecan; (Dato-DXd, DS-1062a)
Phase: Phase 3
Status: Recruiting
Enrolment: 915 (whole trial, estimated)
Start: 2026-07-16 (actual)
Primary completion: 2030-09-11 (estimated)

## 2. NCT06279728
Records: CT.gov NCT06279728 (last update posted 2025-07-03)
Title: Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients
Sponsor: AstraZeneca (Collaborator); Daiichi Sankyo (Lead sponsor)
Conditions: EGFRm Advanced Non-Small Cell Lung Cancer; EGFRm Metastatic Non-Small Cell Lung Cancer
Interventions: Datopotamab deruxtecan; Dato-DXd; DS-1062a
Phase: Not reported
Status: Not mapped (Expanded access availability, not a recruitment status)
Enrolment: Not reported
Start: No date with this role in this data
Primary completion: No date with this role in this data

## 3. NCT06130553
Records: CT.gov NCT06130553 (last update posted 2026-08-27)
Title: A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
Sponsor: AstraZeneca (Lead sponsor)
Conditions: Advanced Solid Tumors That Are MTAP Deficient
Interventions: AZD3470; Datopotamab deruxtecan; Dato-DXd
Phase: Phase 1; Phase 2
Status: Recruiting
Enrolment: 334 (whole trial, estimated)
Start: 2024-01-18 (actual)
Primary completion: 2028-12-04 (estimated)

## 4. NCT06417814 · EU CT 2024-511362-37-00
Records: CT.gov NCT06417814 (last update posted 2026-05-14); CTIS 2024-511362-37-00 https://euclinicaltrials.eu/ctis-public/view/2024-511362-37-00 (access date not in this data)
Registries differ on: start
Title: A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer [CT.gov]; A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15) [CTIS]
Sponsor: AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca AB (Lead sponsor) [CTIS]
Conditions: Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Carcinoma (MeSH D002277, registry index term) [CT.gov]; Metastatic Non-small Cell Lung Cancer [CT.gov];  (MedDRA 10079440) [CTIS]; Non squamous non-small cell lung cancer (NSCLC) [CTIS]
Interventions: Osimertinib [CT.gov]; Tagrisso [CT.gov]; AZD9291 [CT.gov]; Carboplatin [CT.gov]; Pemetrexed [CT.gov]; Cisplatin [CT.gov]; Dato-DXd [CT.gov]; DS-1062a [CT.gov]; CARBOPLATIN [CTIS]; CISPLATIN [CTIS]; TAGRISSO 40 mg film-coated tablets [CTIS]; PEMETREXED [CTIS]; TAGRISSO 80 mg film-coated tablets [CTIS]; Datopotamab deruxtecan [CTIS]
Phase: Phase 3 [CT.gov, CTIS]
Status: Recruiting [CT.gov]; Not collected yet [CTIS]
Enrolment: 744 (whole trial, estimated) [CT.gov]
Start: 2024-10-04 (actual) [CT.gov]; 2026-02-18 (status not stated) [CTIS]
Primary completion: 2026-09-30 (estimated) [CT.gov]

## 5. NCT04656652 · EU CT 2023-509865-19-00 · EudraCT 2020-004643-80
Records: CTIS 2023-509865-19-00 https://euclinicaltrials.eu/ctis-public/view/2023-509865-19-00 (access date not in this data); CT.gov NCT04656652 (last update posted 2026-08-26); EUCTR 2020-004643-80, member state records: BE, DE, FR, IT, HU, NL, CZ
Registries differ on: status, start
Title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer with or without Actionable Genomic Alterations [EUCTR]; PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH OR WITHOUT ACTIONABLE GENOMIC ALTERATIONS (TROPION-LUNG01) [CTIS]; Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) [CT.gov]
Sponsor: Daiichi Sankyo, Inc. (Sponsor) [EUCTR]; DAIICHI SANKYO INC. (Sponsor) [EUCTR]; Daiichi Sankyo Inc. (Lead sponsor) [CTIS]; AstraZeneca (Collaborator) [CT.gov]; Daiichi Sankyo (Lead sponsor) [CT.gov]
Conditions:  (MedDRA 10061873) [EUCTR, CTIS]; Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) [EUCTR, CTIS]; Lung cancer [EUCTR]; carcinoma polmonare [EUCTR]; carcinoma polmonare non a piccole cellule avanzato o metastatico [EUCTR]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Non-small Cell Lung Cancer [CT.gov]
Interventions: DOCETAXEL [EUCTR, CTIS]; 114977-28-5 [EUCTR]; DS-1062a [EUCTR, CT.gov]; ADC of a MAb, MAAP-9001a, conjugated with a drug-linker, MAAA-1162a (datopotamab deruxtecan) [EUCTR]; 2238831-60-0 [EUCTR]; Docetaxel [EUCTR, CT.gov]; taxotere [EUCTR]; Datopotamab deruxtecan [CTIS]; Datopotamab deruxtecan (Dato-DXd) [CT.gov]
Phase: Phase IV: No, as the registry flags it [EUCTR]; Phase 3 [EUCTR, CT.gov, CTIS]; Phase I: No, as the registry flags it [EUCTR]; Phase II: No, as the registry flags it [EUCTR]
Status: Active, not recruiting [CT.gov]; Completed [EUCTR]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Not collected yet [CTIS]
Enrolment: 188 (eea, planned) [EUCTR]; 590 (whole trial, planned) [EUCTR]; 13 (member state BE, planned) [EUCTR]; 26 (member state DE, planned) [EUCTR]; 26 (member state FR, planned) [EUCTR]; 21 (member state IT, planned) [EUCTR]; 15 (member state HU, planned) [EUCTR]; 14 (member state NL, planned) [EUCTR]; 605 (whole trial, actual) [CT.gov]; 10 (member state CZ, planned) [EUCTR]
Start: 2021-04-30 (status not stated) [CTIS]; 2020-12-21 (actual) [CT.gov]
Primary completion: 2024-05-10 (actual) [CT.gov]

## 6. NCT05117476 · EU CT 2024-511744-27-00
Records: CT.gov NCT05117476 (last update posted 2025-11-24); CTIS 2024-511744-27-00 https://euclinicaltrials.eu/ctis-public/view/2024-511744-27-00 (access date not in this data)
Registries differ on: start
Title: A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors [CT.gov]
Sponsor: Cullinan Therapeutics Inc. (Lead sponsor) [CT.gov]; Cullinan Mica Corp. (Lead sponsor) [CTIS]
Conditions: NSCLC [CT.gov]; Advanced Solid Tumor [CT.gov];  (MedDRA 10061451) [CTIS];  (MedDRA 10049280) [CTIS];  (MedDRA 10008229) [CTIS];  (MedDRA 10015362) [CTIS];  (MedDRA 10033128) [CTIS];  (MedDRA 10014733) [CTIS];  (MedDRA 10006187) [CTIS];  (MedDRA 10017758) [CTIS]; Solid tumors, Non-Small Cell Lung Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, breast cancer, gastrointestinal cancer [CTIS];  (MedDRA 10061873) [CTIS]
Interventions: Pembrolizumab [CT.gov]; CLN-619 [CT.gov]; Carboplatin AUC 6 [CT.gov]; Paclitaxel [CT.gov]; pemetrexed [CT.gov]; Datopotamab deruxtecan-dlnk (Dato-DXd) [CT.gov]
Phase: Phase 1 [CT.gov, CTIS]
Status: Active, not recruiting [CT.gov]; Not collected yet [CTIS]
Enrolment: 440 (whole trial, estimated) [CT.gov]
Start: 2021-10-29 (actual) [CT.gov]; 2022-06-27 (status not stated) [CTIS]
Primary completion: 2026-03 (estimated) [CT.gov]

## 7. NCT04526691 · EU CT 2023-508003-20-00
Records: CT.gov NCT04526691 (last update posted 2026-05-15); CTIS 2023-508003-20-00 https://euclinicaltrials.eu/ctis-public/view/2023-508003-20-00 (access date not in this data)
Registries differ on: start
Title: Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02) [CT.gov]
Sponsor: Daiichi Sankyo (Lead sponsor) [CT.gov]; Merck Sharp & Dohme LLC (Collaborator) [CT.gov]; Daiichi Sankyo Inc. (Lead sponsor) [CTIS]
Conditions: Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Advanced or Metastatic NSCLC [CT.gov];  (MedDRA 10061873) [CTIS]; Non-small cell lung cancer [CTIS]
Interventions: KEYTRUDA® [CT.gov]; pembrolizumab [CT.gov]; Cisplatin [CT.gov]; Carboplatin [CT.gov]; Datopotamab deruxtecan [CT.gov]; Dato-DXd [CT.gov]
Phase: Phase 1 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Active, not recruiting [CT.gov]
Enrolment: 145 (whole trial, actual) [CT.gov]
Start: 2020-09-15 (actual) [CT.gov]; 2021-09-27 (status not stated) [CTIS]
Primary completion: 2024-04-14 (actual) [CT.gov]

## 8. NCT05555732 · EU CT 2022-500802-16-00
Records: CTIS 2022-500802-16-00 https://euclinicaltrials.eu/ctis-public/view/2022-500802-16-00 (access date not in this data); CT.gov NCT05555732 (last update posted 2026-06-23)
Registries differ on: start
Title: A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS<50% Non-squamous Non-small Cell Lung Cancer without Actionable Genomic Alterations (TROPION-Lung07) [CTIS]; Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) [CT.gov]
Sponsor: Daiichi Sankyo Inc. (Lead sponsor) [CTIS]; AstraZeneca (Collaborator) [CT.gov]; Merck Sharp & Dohme LLC (Collaborator) [CT.gov]; Daiichi Sankyo (Lead sponsor) [CT.gov]
Conditions: Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations [CTIS];  (MedDRA 10061873) [CTIS]; Metastatic Non Small Cell Lung Cancer [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]
Interventions: KEYTRUDA 25 mg/mL concentrate for solution for infusion [CTIS]; Datopotamab deruxtecan [CTIS]; CISPLATIN [CTIS]; PEMETREXED [CTIS]; CARBOPLATIN [CTIS]; Pemetrexed [CT.gov]; Alimta [CT.gov]; Pemfexy [CT.gov]; Pembrolizumab [CT.gov]; KEYTRUDA® [CT.gov]; Carboplatin [CT.gov]; Datopotamab Deruxtecan [CT.gov]; Dato-DXd [CT.gov]; Cisplatin [CT.gov]
Phase: Phase 3 [CT.gov, CTIS]
Status: Active, not recruiting [CT.gov]; Not collected yet [CTIS]
Enrolment: 1,170 (whole trial, estimated) [CT.gov]
Start: 2023-11-01 (status not stated) [CTIS]; 2023-01-11 (actual) [CT.gov]
Primary completion: 2029-05-11 (estimated) [CT.gov]

## 9. NCT07357597
Records: CT.gov NCT07357597 (last update posted 2026-09-30)
Title: An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Sponsor: Daiichi Sankyo (Collaborator); AstraZeneca (Lead sponsor)
Conditions: Stomatitis (MeSH D013280, registry index term); Stomatitis
Interventions: Datopotamab Deruxtecan (Dato-DXd); Datroway; Dexamethasone mouthwash
Phase: Phase 4
Status: Recruiting
Enrolment: 100 (whole trial, estimated)
Start: 2026-06-24 (actual)
Primary completion: 2028-01-04 (estimated)

## 10. NCT07582887
Records: CT.gov NCT07582887 (last update posted 2026-05-13)
Title: Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response
Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental (Lead sponsor)
Conditions: Metastatic Breast Cancer; Breast Cancer; Pharmacogenetic Variant; Breast Neoplasms (MeSH D001943, registry index term); Drug-Related Side Effects and Adverse Reactions; Drug-Related Side Effects and Adverse Reactions (MeSH D064420, registry index term)
Interventions: Sacituzumab Govitecan; Trastuzumab deruxtecan; Datopotamab Deruxtecan
Phase: Not reported
Status: Recruiting
Enrolment: 70 (whole trial, estimated)
Start: 2025-07-15 (actual)
Primary completion: 2026-12-31 (estimated)

## 11. NCT05460273
Records: CT.gov NCT05460273 (last update posted 2026-08-31)
Title: A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)
Sponsor: AstraZeneca (Lead sponsor); Daiichi Sankyo (Collaborator)
Conditions: Triple Negative Breast Neoplasms (MeSH D064726, registry index term); Carcinoma, Non-Small-Cell Lung; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term); Triple Negative Breast Cancer
Interventions: Datopotamab Deruxtecan (Dato-DXd); DS-1062a
Phase: Phase 2; Phase 1
Status: Active, not recruiting
Enrolment: 119 (whole trial, actual)
Start: 2022-07-11 (actual)
Primary completion: 2023-11-07 (actual)

## 12. NCT04484142 · EU CT 2024-511449-21-00 · EudraCT 2020-002774-27
Records: CT.gov NCT04484142 (last update posted 2026-03-24); CTIS 2024-511449-21-00 https://euclinicaltrials.eu/ctis-public/view/2024-511449-21-00 (access date not in this data); EUCTR 2020-002774-27, member state records: HU, IT, DE, FR, NL
Registries differ on: start
Title: Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed on or After Kinase Inhibitor Therapy and Platinum-based Chemotherapy (TROPION-Lung05) [EUCTR]; Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) [CT.gov]; Phase 2, Single-arm, Open-label Study of DS1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed on or After Applicable Targeted Therapy and Platinumbased Chemotherapy (TROPION-Lung05) [CTIS]
Sponsor: Daiichi Sankyo, Inc. (Sponsor) [EUCTR]; DAIICHI SANKYO INC. (Sponsor) [EUCTR]; Daiichi Sankyo (Lead sponsor) [CT.gov]; AstraZeneca (Collaborator) [CT.gov]; Daiichi Sankyo Inc. (Lead sponsor) [CTIS]
Conditions: Lung Cancer [EUCTR]; Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) [EUCTR, CTIS];  (MedDRA 10061873) [EUCTR, CTIS]; carcinoma polmonare [EUCTR]; carcinoma polmonare non a piccole cellule avanzato o metastatico [EUCTR]; Non-small Cell Lung Cancer [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]
Interventions: DS-1062a [EUCTR, CT.gov]; ADC of a MAb, MAAP-9001a, conjugated with a drug-linker, MAAA-1162a (datopotamab deruxtecan) [EUCTR]; 2238831-60-0 [EUCTR]; Datopotamab Deruxtecan [CT.gov]; datopotamab deruxtecan [EUCTR]; Datopotamab deruxtecan [CTIS]
Phase: Phase IV: No, as the registry flags it [EUCTR]; Phase III: No, as the registry flags it [EUCTR]; Phase 2 [EUCTR, CTIS, CT.gov]; Phase I: No, as the registry flags it [EUCTR]
Status: Completed [EUCTR, CT.gov]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Not collected yet [CTIS]
Enrolment: 73 (eea, planned) [EUCTR]; 150 (whole trial, planned) [EUCTR]; 6 (member state HU, planned) [EUCTR]; 10 (member state IT, planned) [EUCTR]; 137 (whole trial, actual) [CT.gov]; 17 (member state DE, planned) [EUCTR]; 16 (member state FR, planned) [EUCTR]; 13 (member state NL, planned) [EUCTR]
Start: 2021-03-30 (actual) [CT.gov]; 2021-03-25 (status not stated) [CTIS]
Primary completion: 2023-03-10 (actual) [CT.gov]

## 13. NCT07471776
Records: CT.gov NCT07471776 (last update posted 2026-03-13)
Title: Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Sponsor: Fudan University (Lead sponsor)
Conditions: Breast Neoplasms (MeSH D001943, registry index term); Metastatic Breast Cancer ( HER2 Negative)
Interventions: 68Ga-TROP2 PET/CT Imaging; Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan; 18F-FDG PET Imaging
Phase: Phase 2
Status: Recruiting
Enrolment: 45 (whole trial, estimated)
Start: 2026-03-11 (actual)
Primary completion: 2028-03-11 (estimated)

## 14. NCT06244485 · EU CT 2024-516916-93-00
Records: CTIS 2024-516916-93-00 https://euclinicaltrials.eu/ctis-public/view/2024-516916-93-00 (access date not in this data); CT.gov NCT06244485 (last update posted 2026-09-15)
Registries differ on: start
Title: A phase 1B, multicenter, open-label study of Valemetostat Tosylate in combination with DXd ADCs in subjects with solid tumors(study of Valemetostat Tosylate in combination with DXd ADCs) [CTIS]; A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors [CT.gov]
Sponsor: Daiichi Sankyo Inc. (Lead sponsor) [CTIS]; Daiichi Sankyo (Lead sponsor) [CT.gov]
Conditions:  (MedDRA 10065252) [CTIS]; This study will be a Phase 1b, global, multicenter, open-label, 2-part study of valemetostat in combination with DXd ADCs. The Master Protocol study design contains independent subprotocols, which have been defined by treatment combination and subject population, as follows: Sub-protocol A: Valemetostat in combination with T-DXd in subjects with previously treated, unresectable and/or metastatic HER2-low (immunohistochemistry[IHC] 1+ or IHC 2+/in situ hybridization [ISH]-negative) BC; for details, see Sub-protocol A. Sub-protocol B: Valemetostat in combination with T-DXd in subjects with previously treated, advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma; for details, see Sub-protocol B. Sub-protocol C: Valemetostat in combination with Dato-DXd in subjects with previously treated, locally advanced, unresectable, or metastatic non-squamous NSCLC with or without actionable genomic alteration(s); for details, see Sub-protocol C. [CTIS]; Advanced Solid Tumor [CT.gov]
Interventions: Datopotamab deruxtecan [CTIS]; DS-8201a [CTIS, CT.gov]; Valemetostat Tosylate [CTIS]; Dato-DXd [CT.gov]; DS-1062a [CT.gov]; Valemetostat tosylate [CT.gov]; DS-3201b [CT.gov]; T-DXd [CT.gov]; ENHERTU [CT.gov]
Phase: Phase 1 [CT.gov, CTIS]
Status: Active, not recruiting [CT.gov]; Not collected yet [CTIS]
Enrolment: 210 (whole trial, estimated) [CT.gov]
Start: 2025-09-08 (status not stated) [CTIS]; 2024-02-22 (actual) [CT.gov]
Primary completion: 2028-11-01 (estimated) [CT.gov]

## 15. NCT06676917 · EU CT 2024-512369-14-00
Records: CTIS 2024-512369-14-00 https://euclinicaltrials.eu/ctis-public/view/2024-512369-14-00 (access date not in this data); CT.gov NCT06676917 (last update posted 2025-08-08)
Title: A multicenter, open-label, non-comparative, single-arm, phase II trial of datopotamab deruxtecan for non-squamous non-small cell lung cancer patients with active brain metastases (The TUXEDO-5 Study) [CTIS]; Datopotamab Deruxtecan (Dato-DXd) for Non-Small Cell Lung Cancer (NSCLC) Patients With Active Brain Metastases [CT.gov]
Sponsor: Medica Scientia Innovation Research S.L. (Lead sponsor) [CTIS]; MedSIR (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]
Conditions: Non-small cell lung cancer (NSCLC). [CTIS]; Neoplasm Metastasis (MeSH D009362, registry index term) [CT.gov]; Non-small Cell Lung Cancer [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]
Interventions: Polaramine 2 mg comprimidos [CTIS]; Paracetamol Sandoz 500 mg – Tabletten [CTIS]; Datopotamab deruxtecan [CTIS, CT.gov]; Paracetamol Kabi 10 mg/ml solución para perfusión [CTIS]; Dibondrin Ampullen [CTIS]; Dibondrin Dragees [CTIS]; Polaramine 5 mg/ml solución inyectable [CTIS]; Dato-DXd, DS-1062a [CT.gov]
Phase: Phase 2 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Withdrawn [CT.gov]
Enrolment: 0 (whole trial, actual) [CT.gov]
Start: 2025-06 (estimated) [CT.gov]
Primary completion: 2027-08 (estimated) [CT.gov]

## 16. NCT03742102 · EU CT 2024-511646-40-00 · EudraCT 2018-000764-29
Records: CT.gov NCT03742102 (last update posted 2026-08-04); CTIS 2024-511646-40-00 https://euclinicaltrials.eu/ctis-public/view/2024-511646-40-00 (access date not in this data); EUCTR 2018-000764-29, member state records: PL, GB
Registries differ on: enrolment, start
Title: A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First line Metastatic Triple Negative Breast Cancer [EUCTR]; A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer [CT.gov]; A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer (BEGONIA) [CTIS]
Sponsor: AstraZeneca AB (Sponsor) [EUCTR]; AstraZeneca (Lead sponsor) [CT.gov]; AstraZeneca AB (Lead sponsor) [CTIS]
Conditions: First-line (1L) Stage IV Triple Negative Breast Cancer (TNBC) - the subtype of breast cancer characterized by a lack of tumor expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2. [EUCTR, CTIS]; Leczenie pierwszej linii (1l) potrójnie negatywnego raka piersi z przerzutami (TNBC) [EUCTR]; Pierwsza linia (1L) leczenia potrójnie negatywnego raka piersi (TNBC) w stadium IV, podtypu raka piersi charakteryzującego się brakiem ekspresji receptorów estrogenowych i progesteronowych oraz receptora ludzkiego naskórkowego czynnika wzrostu 2 (HER2) w nowotworze. [EUCTR]; Treatment of first line (1L) metastatic triple negative breast cancer (TNBC). [EUCTR];  (MedDRA 10075566) [EUCTR, CTIS]; Triple Negative Breast Neoplasms [CT.gov]; Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]; Triple Negative Breast Neoplasms (MeSH D064726, registry index term) [CT.gov]
Interventions: Trastuzumab Deruxtecan [EUCTR]; 1826843-81-5 [EUCTR]; durvalumab [EUCTR]; 1428935-60-7 [EUCTR]; Capivasertib [EUCTR, CT.gov, CTIS]; 1143532-39-1 [EUCTR]; Oleclumab [EUCTR, CT.gov, CTIS]; MEDI9447 [EUCTR, CT.gov]; NA [EUCTR]; Datopotamab deruxtecan [EUCTR, CT.gov, CTIS]; 2238831-60-0 [EUCTR]; Durvalumab [CT.gov]; MEDI4736 [CT.gov]; Paclitaxel [CT.gov]; Trastuzumab deruxtecan [CT.gov]; DS-8201a [CT.gov, CTIS]; AZD5363 [CT.gov]; Dato-DXd; DS-1062a [CT.gov]; IMFINZI 50 mg/mL concentrate for solution for infusion. [CTIS]; PACLITAXEL [CTIS]; INFLIXIMAB [CTIS]
Phase: Phase 1 [CT.gov, EUCTR]; Phase III: No, as the registry flags it [EUCTR]; Phase 2 [EUCTR, CT.gov]; Phase IV: No, as the registry flags it [EUCTR]; Phase 1, Phase 2 [CTIS]
Status: Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Not collected yet [CTIS]; Active, not recruiting [CT.gov]; Not mapped (The record left EU/EEA jurisdiction) [EUCTR]
Enrolment: 320 (whole trial, planned) [EUCTR]; 49 (member state PL, planned) [EUCTR]; 85 (eea, planned) [EUCTR]; 243 (whole trial, actual) [CT.gov]; 81 (eea, planned) [EUCTR]; 9 (member state GB, planned) [EUCTR]; 191 (whole trial, planned) [EUCTR]
Start: 2018-12-21 (actual) [CT.gov]; 2019-07-11 (status not stated) [CTIS]
Primary completion: 2024-11-29 (actual) [CT.gov]

## 17. NCT05489211 · EU CT 2023-509436-26-00 · EudraCT 2022-000776-19
Records: CT.gov NCT05489211 (last update posted 2026-09-23); CTIS 2023-509436-26-00 https://euclinicaltrials.eu/ctis-public/view/2023-509436-26-00 (access date not in this data); EUCTR 2022-000776-19, member state records: ES, IT, FR, PL
Registries differ on: enrolment, start
Title: Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) [CT.gov]; A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03) [EUCTR, CTIS]
Sponsor: AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca AB (Sponsor) [EUCTR]; AstraZeneca AB (Lead sponsor) [CTIS]; ASTRAZENECA AB (Sponsor) [EUCTR]
Conditions: Stomach Neoplasms (MeSH D013274, registry index term) [CT.gov]; Endometrial Neoplasms (MeSH D016889, registry index term) [CT.gov]; Biliary Tract Cancer [CT.gov]; Metastatic Castration-resistant Prostate Cancer [CT.gov]; Colorectal Neoplasms (MeSH D015179, registry index term) [CT.gov]; Urothelial Cancer [CT.gov]; Colorectal Cancer [CT.gov]; Ovarian Cancer [CT.gov]; Ovarian Neoplasms (MeSH D010051, registry index term) [CT.gov]; Biliary Tract Neoplasms (MeSH D001661, registry index term) [CT.gov]; Gastric Cancer [CT.gov]; Endometrial Cancer [CT.gov]; Cáncer metastásico, Múltiples cánceres [EUCTR]; Metastatic Cancer, Multiple cancers [EUCTR];  (MedDRA 10007129) [EUCTR]; Various Advanced/Metastatic solid tumour types [EUCTR]; Varios tipos de tumores sólidos avanzados/metastásicos [EUCTR];  (MedDRA 10029104) [CTIS]; Endometrial Cancer; Gastric Cancer; Metastatic Castration-resistant Prostate Cancer; Ovarian Cancer; Colorectal Cancer; Urothelial Cancer; Biliary Tract Cancer; [CTIS]; Carcinoma metastatico, carcinoma multipli [EUCTR];  (MedDRA 10068775) [EUCTR]; various Advanced/Metastatic solid tumour types [EUCTR]
Interventions: Carboplatin [CT.gov, EUCTR]; Paraplatin [CT.gov]; Capecitabine [CT.gov, EUCTR]; Xeloda [CT.gov]; Rilvegostomig [CT.gov, CTIS, EUCTR]; AZD2936 [CT.gov]; Prednisone/ prednisolone [CT.gov]; Prednisolone [CT.gov, EUCTR]; Volrustomig [CT.gov, EUCTR]; MEDI5752 [CT.gov]; 5-Fluorouracil [CT.gov, EUCTR]; Adrucil [CT.gov]; Cisplatin [CT.gov]; Platinol [CT.gov]; Bevacizumab [CT.gov, EUCTR]; Avastin [CT.gov]; Datopotamab deruxtecan (Dato-DXd) [CT.gov]; DS-1062a [CT.gov]; Durvalumab [EUCTR]; 1428935-60-7 [EUCTR]; 216974-75-3 [EUCTR]; 154361-50-9 [EUCTR]; leucovorin [EUCTR]; 1492-18-8 [EUCTR]; Flourouracil (5-FU) [EUCTR]; fluorouracil [EUCTR]; 51-21-8 [EUCTR]; Nivolumab [EUCTR]; 946414-94-4 [EUCTR]; Datopotamab deruxtecan [EUCTR, CTIS]; 2238831-60-0 [EUCTR]; 41575-94-4 [EUCTR]; AZD5305 [EUCTR]; N/A [EUCTR]; 2589531-76-8 [EUCTR]; CAPECITABINE [CTIS]; CARBOPLATIN [CTIS]; MYCOPHENOLATE MOFETIL [CTIS]; INFLIXIMAB [CTIS, EUCTR]; PREDNISOLONE [CTIS]; BEVACIZUMAB [CTIS, EUCTR]; CISPLATIN [CTIS]; volrustomig [CTIS]; CALCIUM FOLINATE [CTIS]; FLUOROURACIL [CTIS]; FLUOROURACILE [EUCTR]; CAPECITABINA [EUCTR]; Acetaminophen [EUCTR]; Infliximab [EUCTR]; Glucocorticoids [EUCTR]; Mycophenolate [EUCTR]; MICOFENOLATO MOFETILE [EUCTR]; CARBOPLATINO [EUCTR]; Antihistamines [EUCTR]; Leucovorin [EUCTR]; CALCIO FOLINATO [EUCTR]; NIVOLUMAB [EUCTR]; 2640305-01-5 [EUCTR]; 53-03-2 [EUCTR]; 2407760-40-9 [EUCTR]; 0216974-75-3 [EUCTR]; leucovorin / Calcium folinate [EUCTR]
Phase: Phase III: No, as the registry flags it [EUCTR]; Phase 2 [EUCTR, CTIS, CT.gov]; Phase I: No, as the registry flags it [EUCTR]; Phase IV: No, as the registry flags it [EUCTR]
Status: Not collected yet [CTIS]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Recruiting [CT.gov]; Not mapped (Ongoing; whether it is recruiting is not stated) [EUCTR]
Enrolment: 454 (whole trial, estimated) [CT.gov]; 541 (whole trial, planned) [EUCTR]; 245 (eea, planned) [EUCTR]; 27 (member state ES, planned) [EUCTR]; 40 (member state IT, planned) [EUCTR]; 550 (whole trial, planned) [EUCTR]; 43 (member state FR, planned) [EUCTR]; 33 (member state PL, planned) [EUCTR]; 670 (whole trial, planned) [EUCTR]; 303 (eea, planned) [EUCTR]
Start: 2022-09-06 (actual) [CT.gov]; 2022-12-05 (status not stated) [CTIS]
Primary completion: 2027-10-01 (estimated) [CT.gov]

## 18. NCT03401385
Records: CT.gov NCT03401385 (last update posted 2026-09-01)
Title: First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
Sponsor: Daiichi Sankyo (Collaborator); AstraZeneca (Collaborator); Daiichi Sankyo Co., Ltd. (Lead sponsor)
Conditions: Non-small Cell Lung Cancer; Triple Negative Breast Cancer; Triple Negative Breast Neoplasms (MeSH D064726, registry index term); Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term); Hormone Receptor Positive Breast Cancer
Interventions: Non-Steroid Containing Mouthwash; Datopotamab Deruxtecan (Dato-DXd); DS1062a; Study treatment; Steroid Containing Mouthwash
Phase: Phase 1
Status: Active, not recruiting
Enrolment: 890 (whole trial, estimated)
Start: 2018-01-31 (actual)
Primary completion: 2028-01-01 (estimated)

## 19. NCT06112379 · EU CT 2023-505928-59-00
Records: CTIS 2023-505928-59-00 https://euclinicaltrials.eu/ctis-public/view/2023-505928-59-00 (access date not in this data); CT.gov NCT06112379 (last update posted 2026-07-13)
Registries differ on: start
Title: A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients with Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04) [CTIS]; A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer [CT.gov]
Sponsor: Astrazeneca AB (Lead sponsor) [CTIS]; Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca (Lead sponsor) [CT.gov]
Conditions: Triple Negative or Hormone Receptor low/HER2-negative Breast Cancer [CTIS];  (MedDRA 10029104) [CTIS];  (MedDRA 10075566) [CTIS]; Breast Cancer [CT.gov]; Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]
Interventions: MYCOPHENOLATE MOFETIL [CTIS]; CYCLOPHOSPHAMIDE [CTIS]; DOXORUBICIN [CTIS]; Lynparza 100 mg film-coated tablets [CTIS]; PACLITAXEL [CTIS]; INFLIXIMAB [CTIS]; CAPECITABINE [CTIS]; PEMBROLIZUMAB [CTIS]; Lynparza 150 mg film-coated tablets [CTIS]; CARBOPLATIN [CTIS]; EPIRUBICIN [CTIS]; IMFINZI 50 mg/mL concentrate for solution for infusion. [CTIS]; Datopotamab deruxtecan [CTIS]; Cyclophosphamide [CT.gov]; Capecitabine [CT.gov]; XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord [CT.gov]; Epirubicin [CT.gov]; Olaparib [CT.gov]; LYNPARZA® [CT.gov]; Durvalumab [CT.gov]; MEDI4736 [CT.gov]; Carboplatin [CT.gov]; Doxorubicin [CT.gov]; Dato-DXd [CT.gov]; Datopotamab deruxtecan (Dato-DXd, DS-1062a) [CT.gov]; Paclitaxel [CT.gov]; Pembrolizumab [CT.gov]; KEYTRUDA® [CT.gov]
Phase: Phase 3 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Active, not recruiting [CT.gov]
Enrolment: 1,902 (whole trial, actual) [CT.gov]
Start: 2024-04-15 (status not stated) [CTIS]; 2023-11-14 (actual) [CT.gov]
Primary completion: 2028-11-20 (estimated) [CT.gov]

## 20. NCT07291037
Records: CT.gov NCT07291037 (last update posted 2026-09-04)
Title: Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Sponsor: AstraZeneca (Lead sponsor); Daiichi Sankyo (Collaborator)
Conditions: Non-small Cell Lung Cancer (NSCLC); Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term)
Interventions: Datopotamab deruxtecan (Dato-DXd); DS-1062a; Docetaxel
Phase: Phase 3
Status: Recruiting
Enrolment: 400 (whole trial, estimated)
Start: 2025-10-31 (actual)
Primary completion: 2029-01-29 (estimated)

## 21. NCT07098338 · EU CT 2025-524843-11-00
Records: CT.gov NCT07098338 (last update posted 2026-07-01); CTIS 2025-524843-11-00 https://euclinicaltrials.eu/ctis-public/view/2025-524843-11-00 (access date not in this data)
Registries differ on: start
Title: A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) [CT.gov]; A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA) [CTIS]
Sponsor: AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca AB (Lead sponsor) [CTIS]
Conditions: Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Non-Small Cell Lung Cancer [CT.gov, CTIS];  (MedDRA 10061873) [CTIS]
Interventions: Ramucirumab [CT.gov]; Cyramza [CT.gov]; Dato-DXd [CT.gov]; DS-1062 [CT.gov]; Rilvegostomig [CT.gov, CTIS]; AZD2936 [CT.gov]; MYCOPHENOLATE MOFETIL [CTIS]; Datopotamab deruxtecan [CTIS]; INFLIXIMAB [CTIS]; RAMUCIRUMAB [CTIS]
Phase: Phase 2 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Recruiting [CT.gov]
Enrolment: 278 (whole trial, estimated) [CT.gov]
Start: 2025-08-07 (actual) [CT.gov]; 2026-06-15 (status not stated) [CTIS]
Primary completion: 2029-04-06 (estimated) [CT.gov]

## 22. NCT05104866 · EU CT 2023-509631-37-00 · EudraCT 2020-005620-12
Records: CTIS 2023-509631-37-00 https://euclinicaltrials.eu/ctis-public/view/2023-509631-37-00 (access date not in this data); CT.gov NCT05104866 (last update posted 2026-08-24); EUCTR 2020-005620-12, member state records: ES, PL, DE, IT, BE, NL, HU, FR
Registries differ on: status, start
Title: A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy [EUCTR]; A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) [CTIS]; A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) [CT.gov]
Sponsor: AstraZeneca AB (Sponsor) [EUCTR]; ASTRAZENECA AB (Sponsor) [EUCTR]; AstraZeneca AB (Lead sponsor) [CTIS]; AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]
Conditions: Breast Cancer [EUCTR, CT.gov]; Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer that Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy [EUCTR]; Cáncer de mama [EUCTR]; Cáncer de mama inoperable o metastásico, con receptores hormonales positivos, HER2 negativo, tratado una o dos líneas previas de quimioterapia sistémica [EUCTR];  (MedDRA 10083232) [EUCTR]; Nieoperacyjny lub rozsiany raki piersi bez nadmiernej ekspresji receptora HER2 oraz z obecnością receptorów uprzednio leczony systemowo jedną lub dwiema liniami chemioterapii [EUCTR]; Rak piersi [EUCTR]; Carcinoma mammario positivo ai recettori ormonali, HER2 negativo, inoperabile o metastatico che è stato trattato con una o due precedenti linee di chemioterapia sistemica [EUCTR]; Carcinoma mammario [EUCTR]; "Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer that Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy" [CTIS]; Patients with Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer that Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy [EUCTR]; Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]; Neoplasm Metastasis (MeSH D009362, registry index term) [CT.gov]
Interventions: Capecitabine [EUCTR, CT.gov]; 154361-50-9 [EUCTR]; Vinorelbine [EUCTR, CT.gov]; 71486-22-1 [EUCTR]; Datopotamab deruxtecan [EUCTR, CTIS]; 2238831-60-0 [EUCTR]; Gemcitabine [EUCTR, CT.gov]; 95058-81-4 [EUCTR]; Eribulin mesylate [EUCTR]; 441045-17-6 [EUCTR]; CAPECITABINA [EUCTR]; GEMCITABINA [EUCTR]; VINORELBINA [EUCTR]; ERIBULINA [EUCTR]; ERIBULIN MESYLATE [CTIS]; CAPECITABINE [CTIS]; GEMCITABINE [CTIS]; VINORELBINE [CTIS]; Eribulin [CT.gov]; Eribulin Mesylate [CT.gov]; Dato-DXd [CT.gov]; Datopotamab deruxtecan (Dato-DXd, DS-1062a) [CT.gov]
Phase: Phase I: No, as the registry flags it [EUCTR]; Phase IV: No, as the registry flags it [EUCTR]; Phase 3 [EUCTR, CTIS, CT.gov]; Phase II: No, as the registry flags it [EUCTR]
Status: Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Active, not recruiting [CT.gov]; Completed [EUCTR]; Not mapped (Ongoing; whether it is recruiting is not stated) [EUCTR]; Not collected yet [CTIS]
Enrolment: 29 (member state ES, planned) [EUCTR]; 700 (whole trial, planned) [EUCTR]; 255 (eea, planned) [EUCTR]; 50 (member state PL, planned) [EUCTR]; 25 (member state DE, planned) [EUCTR]; 30 (member state IT, planned) [EUCTR]; 18 (member state NL, planned) [EUCTR]; 40 (member state HU, planned) [EUCTR]; 732 (whole trial, actual) [CT.gov]; 25 (member state FR, planned) [EUCTR]
Start: 2022-01-18 (status not stated) [CTIS]; 2021-10-18 (actual) [CT.gov]
Primary completion: 2024-07-24 (actual) [CT.gov]

## 23. EU CT 2025-525030-57-00
Records: CTIS 2025-525030-57-00 https://euclinicaltrials.eu/ctis-public/view/2025-525030-57-00 (access date not in this data)
Title: A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma (TROPION-Urothelial04).
Sponsor: AstraZeneca AB (Lead sponsor)
Conditions: High-risk muscle invasive urothelial carcinoma (MIUC) originating in bladder or upper tract (renal pelvis/ureter).
Interventions: PEMBROLIZUMAB; ENFORTUMAB VEDOTIN; MYCOPHENOLATE MOFETIL; Datopotamab deruxtecan; NIVOLUMAB; Rilvegostomig; INFLIXIMAB; DURVALUMAB
Phase: Phase 3
Status: Not collected yet
Enrolment: Not collected yet
Start: No date with this role in this data
Primary completion: No date with this role in this data

## 24. NCT06103864
Records: CT.gov NCT06103864 (last update posted 2026-09-25)
Title: A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Sponsor: Daiichi Sankyo (Collaborator); AstraZeneca (Lead sponsor)
Conditions: Neoplasm Metastasis (MeSH D009362, registry index term); Breast Cancer; Breast Neoplasms (MeSH D001943, registry index term)
Interventions: Nab-paclitaxel; Durvalumab; MEDI4736; Gemcitabine; Pembrolizumab; Paclitaxel; Dato-DXd; Datopotamab deruxtecan (Dato-DXd, DS-1062a); Carboplatin
Phase: Phase 3
Status: Recruiting
Enrolment: 625 (whole trial, estimated)
Start: 2023-11-23 (actual)
Primary completion: 2027-07-28 (estimated)

## 25. NCT04612751 · EU CT 2023-505992-54-00
Records: CT.gov NCT04612751 (last update posted 2026-07-27); CTIS 2023-505992-54-00 https://euclinicaltrials.eu/ctis-public/view/2023-505992-54-00 (access date not in this data)
Registries differ on: start
Title: Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer [CT.gov]; A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Participants with Advanced or Metastatic Non‑Small Cell Lung Cancer (Tropion-Lung04) [CTIS]
Sponsor: Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca (Lead sponsor) [CT.gov]; Astrazeneca AB (Lead sponsor) [CTIS]
Conditions: Advanced or Metastatic NSCLC [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov];  (MedDRA 10061873) [CTIS]; Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) [CTIS]
Interventions: AZD7789 [CT.gov, CTIS]; sabestomig [CT.gov]; Durvalumab [CT.gov]; Imfinzi [CT.gov]; Carboplatin [CT.gov]; Datopotamab deruxtecan [CT.gov, CTIS]; Dato-DXd [CT.gov]; AZD2936 [CT.gov]; rilvegostomig [CT.gov]; MEDI5752 [CT.gov]; volrustomig [CT.gov, CTIS]; Rilvegostomig [CTIS]; MYCOPHENOLATE MOFETIL [CTIS]; IMFINZI 50 mg/mL concentrate for solution for infusion. [CTIS]; CARBOPLATIN [CTIS]; INFLIXIMAB [CTIS]
Phase: Phase 1 [CTIS, CT.gov]
Status: Active, not recruiting [CT.gov]; Not collected yet [CTIS]
Enrolment: 155 (whole trial, actual) [CT.gov]
Start: 2021-02-02 (actual) [CT.gov]; 2022-10-21 (status not stated) [CTIS]
Primary completion: 2026-05-04 (actual) [CT.gov]

## 26. NCT06974604
Records: CT.gov NCT06974604 (last update posted 2025-10-24)
Title: Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Sponsor: The Miriam Hospital (Collaborator); Brown University (Lead sponsor); Rhode Island Hospital (Collaborator)
Conditions: Lung Neoplasms (MeSH D008175, registry index term); Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term); Triple Negative Breast Neoplasms (MeSH D064726, registry index term); Breast Neoplasms; Lung Neoplasms; Breast Neoplasms (MeSH D001943, registry index term)
Interventions: Dexamethasone oral; Datopotamab Deruxtecan (Dato-DXd DS-1062a)
Phase: Phase 2
Status: Recruiting
Enrolment: 60 (whole trial, estimated)
Start: 2025-10-22 (actual)
Primary completion: 2027-05-31 (estimated)

## 27. NCT05866432
Records: CT.gov NCT05866432 (last update posted 2025-09-25)
Title: Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Sponsor: Daiichi Sankyo (Collaborator); Medical University of Vienna (Lead sponsor)
Conditions: Breast Neoplasms (MeSH D001943, registry index term); Breast Cancer Stage IV
Interventions: Datopotamab deruxtecan; S-1062a
Phase: Phase 2
Status: Recruiting
Enrolment: 20 (whole trial, estimated)
Start: 2023-07-01 (actual)
Primary completion: 2026-05-23 (estimated)

## 28. NCT06350097 · EU CT 2023-509883-89-00
Records: CTIS 2023-509883-89-00 https://euclinicaltrials.eu/ctis-public/view/2023-509883-89-00 (access date not in this data); CT.gov NCT06350097 (last update posted 2026-08-26)
Registries differ on: start
Title: A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (TROPION‑Lung14) [CTIS]; Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer [CT.gov]
Sponsor: AstraZeneca AB (Lead sponsor) [CTIS]; AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]
Conditions: Epidermal growth factor receptor (EGFR) mutation-positive, locally advanced or metastatic non squamous non-small cell lung cancer [CTIS];  (MedDRA 10079440) [CTIS]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Non-small Cell Lung Cancer [CT.gov]
Interventions: TAGRISSO 40 mg film-coated tablets [CTIS]; Datopotamab deruxtecan [CTIS]; TAGRISSO 80 mg film-coated tablets [CTIS]; Osimertinib [CT.gov]; Osimertinib: Tagrisso, AZD9291 [CT.gov]; Datopotamab Deruxtecan [CT.gov]; Dato-DXd, DS-1062a [CT.gov]
Phase: Phase 3 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Recruiting [CT.gov]
Enrolment: 582 (whole trial, estimated) [CT.gov]
Start: 2025-01-09 (status not stated) [CTIS]; 2024-04-29 (actual) [CT.gov]
Primary completion: 2028-03-21 (estimated) [CT.gov]

## 29. NCT05417594 · EU CT 2023-504984-17-00 · EudraCT 2021-006227-17
Records: CTIS 2023-504984-17-00 https://euclinicaltrials.eu/ctis-public/view/2023-504984-17-00 (access date not in this data); CT.gov NCT05417594 (last update posted 2026-10-05); EUCTR 2021-006227-17, member state records: ES, SE
Registries differ on: enrolment, start
Title: A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies [CTIS]; A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1) [EUCTR]; Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies [CT.gov]
Sponsor: AstraZeneca AB (Lead sponsor) [CTIS]; AstraZeneca AB (Sponsor) [EUCTR]; AstraZeneca (Lead sponsor) [CT.gov]
Conditions: Module 2: IDH-mutant glioma [CTIS];  (MedDRA 10062195) [CTIS];  (MedDRA 10017760) [CTIS];  (MedDRA 10063157) [CTIS, EUCTR];  (MedDRA 10033128) [CTIS, EUCTR];  (MedDRA 10014735) [CTIS]; Module 1: advanced/relapsed ovarian, breast, pancreatic or prostate cancer where patients loss of function or predicted loss of function mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D [CTIS];  (MedDRA 10029514) [CTIS];  (MedDRA 10006128) [CTIS];  (MedDRA 10006187) [CTIS, EUCTR];  (MedDRA 10033604) [CTIS, EUCTR];  (MedDRA 10010029) [CTIS]; Module 3: advanced/relapsed HER2-negative breast, ovarian, prostate, or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm, IDH-mutant recurrent glioma, breast cancer (without BM) [CTIS]; Module 4: advanced,unresectable and HER2+ metastatic solid tumours; NSCLC, HER2 activating mutation [CTIS];  (MedDRA 10005003) [CTIS];  (MedDRA 10060862) [CTIS, EUCTR]; Module 5: advanced,unresectable or metastatic solid tumours in breast, endometrial, ovarian and prostate cancer [CTIS];  (MedDRA 10008229) [CTIS]; Prostatic Neoplasms (MeSH D011471, registry index term) [CT.gov]; Glioma (MeSH D005910, registry index term) [CT.gov]; Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]; Advanced Solid Malignancies [CT.gov]; Astrocytoma (MeSH D001254, registry index term) [CT.gov]; Fallopian Tube Neoplasms (MeSH D005185, registry index term) [CT.gov]; Pancreatic Neoplasms (MeSH D010190, registry index term) [CT.gov]; Ovarian Neoplasms (MeSH D010051, registry index term) [CT.gov]
Interventions: TEMOZO-cell® 20 mg Hartkapseln [CTIS]; AZD9574 [CTIS, EUCTR, CT.gov]; DS-8201a [CTIS]; Datopotamab deruxtecan [CTIS]; TEMOZO-cell® 100 mg Hartkapseln [CTIS]; TEMOZO-cell ®250 mg Hartkapseln [CTIS]; TEMOZO-cell® 180 mg Hartkapseln [CTIS]; TEMOZO-cell® 5 mg Hartkapseln [CTIS]; TEMOZO-cell® 140 mg Hartkapseln [CTIS]; Temozolomide [EUCTR]; 85622-93-1 [EUCTR]; ‘Not yet available’ [EUCTR]; Not yet available [EUCTR]; [11 C] AZ14193391 [EUCTR]; [11C]AZ1419 3391 [CT.gov]; Datopotamab Deruxtecan (Dato-DXd) [CT.gov]; Temozolomide (TMZ) [CT.gov]; Trastuzumab Deruxtecan (T-DXd) [CT.gov]
Phase: Phase III: No, as the registry flags it [EUCTR]; Phase 2 [EUCTR, CT.gov]; Phase 1 [EUCTR, CT.gov]; Phase 1, Phase 2 [CTIS]; Phase IV: No, as the registry flags it [EUCTR]
Status: Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Not mapped (Ongoing; whether it is recruiting is not stated) [EUCTR]; Not collected yet [CTIS]; Recruiting [CT.gov]
Enrolment: 255 (whole trial, planned) [EUCTR]; 25 (member state ES, planned) [EUCTR]; 90 (eea, planned) [EUCTR]; 34 (member state SE, planned) [EUCTR]; 105 (eea, planned) [EUCTR]; 270 (whole trial, planned) [EUCTR]; 695 (whole trial, estimated) [CT.gov]
Start: 2022-10-05 (status not stated) [CTIS]; 2022-06-24 (actual) [CT.gov]
Primary completion: 2028-02-07 (estimated) [CT.gov]

## 30. NCT05629585 · EU CT 2023-505552-22-00 · EudraCT 2022-002680-30
Records: CT.gov NCT05629585 (last update posted 2026-06-15); CTIS 2023-505552-22-00 https://euclinicaltrials.eu/ctis-public/view/2023-505552-22-00 (access date not in this data); EUCTR 2022-002680-30, member state records: BE, ES, DK, IT, SE, GR, DE
Registries differ on: enrolment, start
Title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPIONBreast03) [EUCTR]; A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) [CT.gov]; A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03) [CTIS]
Sponsor: AstraZeneca AB (Sponsor) [EUCTR]; ASTRAZENECA AB (Sponsor) [EUCTR]; SWOG Clinical Trials Partnerships, LLC (Collaborator) [CT.gov]; AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]; Astrazeneca AB (Lead sponsor) [CTIS]
Conditions: Breast cancer [EUCTR];  (MedDRA 10075566) [EUCTR, CTIS]; Stage I-III triple-negative breast cancer with residual invasive disease after neoadjuvant therapy. [EUCTR]; Cáncer de mama triple negativo de estadio I-III con enfermedad residual invasiva en la mama después de tratamiento neoadyuvante [EUCTR]; Cáncer de mama [EUCTR]; Carcinoma Mammario triplo negativo allo stadio I-III che presentano malattia invasiva residua nella mammella dopo terapia neoadiuvante [EUCTR]; Breast Cancer [EUCTR, CT.gov]; Carcinoma Mammario [EUCTR]; Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]; Stage I-III Triple-negative Breast Cancer with residual invasive disease after neoadjuvant systemic therapy. [CTIS]
Interventions: Pembrolizumab [EUCTR, CT.gov]; 1374853-91-4 [EUCTR]; Datopotamab Deruxtecan [EUCTR]; 2238831-60-0 [EUCTR]; Capecitabine [EUCTR, CT.gov]; 154361-50-9 [EUCTR]; Durvalumab [EUCTR, CT.gov]; 1428935-60-7 [EUCTR]; Micofenolato Mofetile [EUCTR]; MICOFENOLATO MOFETILE [EUCTR]; Capecitabina [EUCTR]; CAPECITABINA [EUCTR]; PEMBROLIZUMAB [EUCTR, CTIS]; Infliximab [EUCTR]; INFLIXIMAB [EUCTR, CTIS]; DURVALUMAB [EUCTR]; Micofenolato mofetile [EUCTR]; MEDI4736 [CT.gov]; Dato-DXd [CT.gov]; Datopotamab deruxtecan (Dato-DXd, DS-1062a) [CT.gov]; KEYTRUDA® [CT.gov]; XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord [CT.gov]; CAPECITABINE [CTIS]; MYCOPHENOLATE MOFETIL [CTIS]; IMFINZI 50 mg/mL concentrate for solution for infusion. [CTIS]; Datopotamab deruxtecan [CTIS]
Phase: Phase I: No, as the registry flags it [EUCTR]; Phase 3 [EUCTR, CT.gov, CTIS]; Phase IV: No, as the registry flags it [EUCTR]; Phase II: No, as the registry flags it [EUCTR]
Status: Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Not collected yet [CTIS]; Not mapped (Ongoing; whether it is recruiting is not stated) [EUCTR]; Active, not recruiting [CT.gov]
Enrolment: 1,075 (whole trial, planned) [EUCTR]; 364 (eea, planned) [EUCTR]; 188 (eea, planned) [EUCTR]; 43 (member state ES, planned) [EUCTR]; 32 (member state DK, planned) [EUCTR]; 60 (member state IT, planned) [EUCTR]; 32 (member state SE, planned) [EUCTR]; 40 (member state GR, planned) [EUCTR]; 1,174 (whole trial, actual) [CT.gov]; 56 (member state DE, planned) [EUCTR]
Start: 2022-11-28 (actual) [CT.gov]; 2023-02-24 (status not stated) [CTIS]
Primary completion: 2027-09-20 (estimated) [CT.gov]

## 31. NCT04644068 · EU CT 2022-502856-29-00 · EudraCT 2020-002688-77
Records: CTIS 2022-502856-29-00 https://euclinicaltrials.eu/ctis-public/view/2022-502856-29-00 (access date not in this data); CT.gov NCT04644068 (last update posted 2026-09-21); EUCTR 2020-002688-77, member state records: CZ, PL
Registries differ on: enrolment, start
Title: A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies [EUCTR]; A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (PETRA) [CTIS]; Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies [CT.gov]
Sponsor: AstraZeneca AB (Sponsor) [EUCTR]; AstraZeneca AB (Lead sponsor) [CTIS]; AstraZeneca (Lead sponsor) [CT.gov]
Conditions:  (MedDRA 10048683) [EUCTR]; Advanced Solid Tumors [EUCTR, CTIS]; Cancer [EUCTR]; Colorectal Neoplasms (MeSH D015179, registry index term) [CT.gov]; Pancreatic Neoplasms (MeSH D010190, registry index term) [CT.gov]; Biliary Tract Neoplasms (MeSH D001661, registry index term) [CT.gov]; Pancreatic Cancer [CT.gov]; Urinary Bladder Neoplasms (MeSH D001749, registry index term) [CT.gov]; Prostate Cancer [CT.gov]; Cervical Cancer [CT.gov]; Small Cell Lung Cancer Only in Module 5 [CT.gov]; Endometrial Neoplasms (MeSH D016889, registry index term) [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Biliary Cancer [CT.gov]; Ovarian Neoplasms (MeSH D010051, registry index term) [CT.gov]; Breast Cancer [CT.gov]; Additional Indications Below for Module 4 and 5 [CT.gov]; Uterine Cervical Neoplasms (MeSH D002583, registry index term) [CT.gov]; Prostatic Neoplasms (MeSH D011471, registry index term) [CT.gov]; Gastric Cancer [CT.gov]; Non-small Cell Lung Cancer [CT.gov]; Colorectal Cancer [CT.gov]; Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]; Endometrial Cancer [CT.gov]; Bladder Cancer [CT.gov]; Ovarian Cancer [CT.gov]; Stomach Neoplasms (MeSH D013274, registry index term) [CT.gov]
Interventions: Carboplatin [EUCTR, CT.gov]; 41575-94-4 [EUCTR]; AZD5305 film-coated tablets [EUCTR]; N/A [EUCTR]; 2589531-76-8 [EUCTR]; Paclitaxel [EUCTR, CT.gov]; 33069-62-4 [EUCTR]; Saruparib [CTIS]; PACLITAXEL [CTIS]; Datopotamab deruxtecan [CTIS]; Camizestrant [CTIS, CT.gov]; DS-8201a [CTIS]; AZD5305 [EUCTR, CT.gov]; Trastuzumab deruxtecan [EUCTR]; 1599440-13-7 [EUCTR]; Dato-DXd [CT.gov]; T- Dxd [CT.gov]
Phase: Phase 2 [EUCTR, CT.gov]; Phase 1 [CT.gov, EUCTR]; Phase IV: No, as the registry flags it [EUCTR]; Phase III: No, as the registry flags it [EUCTR]; Phase 1, Phase 2 [CTIS]
Status: Active, not recruiting [CT.gov]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Not collected yet [CTIS]
Enrolment: 864 (whole trial, planned) [EUCTR]; 432 (eea, planned) [EUCTR]; 14 (member state CZ, planned) [EUCTR]; 1,067 (whole trial, planned) [EUCTR]; 8 (member state PL, planned) [EUCTR]; 427 (eea, planned) [EUCTR]; 702 (whole trial, actual) [CT.gov]
Start: 2021-07-27 (status not stated) [CTIS]; 2020-11-12 (actual) [CT.gov]
Primary completion: 2027-05-28 (estimated) [CT.gov]

## 32. NCT01042379
Records: CT.gov NCT01042379 (last update posted 2026-05-06)
Title: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Sponsor: QuantumLeap Healthcare Collaborative (Lead sponsor)
Conditions: Hemangiosarcoma (MeSH D006394, registry index term); HER2-negative Breast Cancer; Pathologic Complete Response (MeSH D000095384, registry index term); Breast Tumors; Hormone Receptor Positive Tumor; Breast Cancer; Angiosarcoma; Neoplasms (MeSH D009369, registry index term); Hormone Receptor Negative Tumor; Locally Advanced Breast Cancer; Early-stage Breast Cancer; Breast Neoplasms (MeSH D001943, registry index term); Breast Neoplasms; HER2-positive Breast Cancer; TNBC - Triple-Negative Breast Cancer; Triple Negative Breast Neoplasms (MeSH D064726, registry index term)
Interventions: GSK 5733584; Datopotamab deruxtecan + Durvalumab; Dato-DXd; Endoxifen + Abemaciclib; Dan222 + Niraparib; ARX788; Ivonescimab (20mg/kg Q3W); AK112; SMT112; PD-1 / VEGF bispecific antibody; 依达方® (Yiwoxi Dankang Zhusheye); Pertuzumab and Trastuzumab; Pertuzumab (Perjeta); Trastuzumab (Herceptin); ARX788 + Cemiplimab; Amcenestrant; SAR439859; AMG 386 and Trastuzumab; AMG 386 (Trebananib); Trastuzumab (Herceptin); ABT-888; Veliparib; ARV-471; Amcenestrant + Abemaciclib; Amcenestrant (SAR439859), Abemaciclib (Verzenio); Talazoparib plus Irinotecan; AMG 386 with or without Trastuzumab; AMG 386 (Trebananib); (Trastuzumab) Herceptin; PLX3397; Lasofoxifene; T-DM1 and Pertuzumab; T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta); Tucatinib plus trastuzumab and pertuzumab; Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab; Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin); ARV-471 + Abemaciclib; Trilaciclib with or without trastuzumab + pertuzumab; Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin); Pembrolizumab - 8 cycle; Durvalumab plus Olaparib; Pembrolizumab - 4 cycle; VV1 + Cemiplimab; VOYAGER V1™; VSV-IFNβ-NIS; SYD985 ([vic-]trastuzumab duocarmazine); Ganetespib; ARV-471 + Letrozole; SD-101 + Pembrolizumab; AMG 479 (Ganitumab) plus Metformin; Ganitumab; Patritumab and Trastuzumab; Datopotamab deruxtecan; Zanidatamab; Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab; Sarilumab + Cemiplimab + Paclitaxel; Standard Therapy; Paclitaxel (Taxol); Doxorubicin (Adriamycin); Cemiplimab; MK-2206 with or without Trastuzumab; (Trastuzumab) Herceptin; Cemiplimab plus REGN3767; Z-endoxifen; Neratinib; GSK 5733584 + Dostarlimab; Amcenestrant + Letrozole; Amcenestrant (SAR439859), Letrozole (Femara); Rilvegostomig + TDXd; SGN-LIV1A
Phase: Phase 2
Status: Recruiting
Enrolment: 5,000 (whole trial, estimated)
Start: 2010-03-01 (actual)
Primary completion: 2030-12 (estimated)

## 33. NCT07069595
Records: CT.gov NCT07069595 (last update posted 2026-04-22)
Title: PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
Sponsor: UNC Lineberger Comprehensive Cancer Center (Lead sponsor); AstraZeneca (Collaborator); Translational Breast Cancer Research Consortium (Collaborator)
Conditions: Breast Cancer; Residual Disease; Stage II/III; Breast Neoplasms (MeSH D001943, registry index term); Triple Negative Breast Cancer (TNBC); Triple Negative Breast Neoplasms (MeSH D064726, registry index term); Neoplasm, Residual (MeSH D018365, registry index term)
Interventions: Circulating tumor DNA (ctDNA) testing; Datopotamab deruxtecan; Dato-DXd
Phase: Phase 2
Status: Recruiting
Enrolment: 78 (whole trial, estimated)
Start: 2026-02-26 (actual)
Primary completion: 2031-11-01 (estimated)

## 34. NCT06954480 · EU CT 2024-519913-76-00
Records: CT.gov NCT06954480 (last update posted 2026-05-22); CTIS 2024-519913-76-00 https://euclinicaltrials.eu/ctis-public/view/2024-519913-76-00 (access date not in this data)
Registries differ on: start
Title: Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer [CT.gov]; An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negative metastatic triple-negative breast cancer [CTIS]
Sponsor: Queen Mary University of London (Lead sponsor) [CT.gov]; AstraZeneca (Collaborator) [CT.gov]; Queen Mary University Of London (Lead sponsor) [CTIS]
Conditions: Breast Neoplasms (MeSH D001943, registry index term) [CT.gov]; Triple Negative Breast Neoplasms (MeSH D064726, registry index term) [CT.gov]; Triple Negative Breast Cancer [CT.gov]; PDL1-negative metastatic triple-negative breast cancer [CTIS]
Interventions: Datopotamab Deruxtecan (Dato-DXd) [CT.gov]; Durvalumab [CT.gov]; DURVALUMAB [CTIS]; Datopotamab deruxtecan [CTIS]
Phase: Phase 2 [CT.gov, CTIS]
Status: Not collected yet [CTIS]; Recruiting [CT.gov]
Enrolment: 140 (whole trial, estimated) [CT.gov]
Start: 2025-10-27 (actual) [CT.gov]; 2025-12-09 (status not stated) [CTIS]
Primary completion: 2028-02 (estimated) [CT.gov]

## 35. NCT07129993
Records: CT.gov NCT07129993 (last update posted 2026-08-20)
Title: Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor: AstraZeneca (Collaborator); Daiichi Sankyo (Lead sponsor)
Conditions: Bladder Cancer; Carcinoma, Transitional Cell (MeSH D002295, registry index term); Urinary Bladder Neoplasms (MeSH D001749, registry index term); Urothelial Cancer
Interventions: Gemcitabine; Cisplatin; Dato-DXd; Datopotamab Deruxtecan; Carboplatin
Phase: Phase 2; Phase 3
Status: Recruiting
Enrolment: 630 (whole trial, estimated)
Start: 2025-09-26 (actual)
Primary completion: 2029-06-01 (estimated)

## 36. EU CT 2025-521904-23-00
Records: CTIS 2025-521904-23-00 https://euclinicaltrials.eu/ctis-public/view/2025-521904-23-00 (access date not in this data)
Title: An Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HR-positive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)
Sponsor: AstraZeneca AB (Lead sponsor)
Conditions:  (MedDRA 10076935);  (MedDRA 10027475); Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy;  (MedDRA 10072740)
Interventions: Datopotamab deruxtecan
Phase: Phase 2
Status: Not collected yet
Enrolment: Not collected yet
Start: 2026-02-17 (status not stated)
Primary completion: No date with this role in this data

## 37. EU CT 2024-516906-47-00
Records: CTIS 2024-516906-47-00 https://euclinicaltrials.eu/ctis-public/view/2024-516906-47-00 (access date not in this data)
Title: A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPION-Urothelial03 (TU03).
Sponsor: Daiichi Sankyo Inc. (Lead sponsor)
Conditions: Locally Advanced or Metastatic Urothelial Carcinoma;  (MedDRA 10064467)
Interventions: Datopotamab deruxtecan; Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung; Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung; Ribozar 1 g Pulver zur Herstellung einer Infusionslösung
Phase: Phase 2, Phase 3
Status: Not collected yet
Enrolment: Not collected yet
Start: 2025-11-28 (status not stated)
Primary completion: No date with this role in this data

## 38. NCT06564844 · EU CT 2024-512195-35-00
Records: CT.gov NCT06564844 (last update posted 2026-09-23); CTIS 2024-512195-35-00 https://euclinicaltrials.eu/ctis-public/view/2024-512195-35-00 (access date not in this data)
Title: A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features [CT.gov]; A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION Lung12) [CTIS]
Sponsor: AstraZeneca (Lead sponsor) [CT.gov]; Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca AB (Lead sponsor) [CTIS]
Conditions: Non-small Cell Lung Cancer [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Adenocarcinoma (MeSH D000230, registry index term) [CT.gov];  (MedDRA 10029517) [CTIS]; Stage I adenocarcinoma non-small cell lung cancer (NSCLC) with ctDNA-positive result or high-risk pathological feature [CTIS]
Interventions: Datopotamab Deruxtecan [CT.gov]; Dato-DXd, DS-1062a [CT.gov]; Pemetrexed [CT.gov]; Vinorelbine [CT.gov]; UFT [CT.gov]; Etoposide [CT.gov]; Cisplatin [CT.gov]; Carboplatin [CT.gov]; Rilvegostomig [CT.gov, CTIS]; AZD2936 [CT.gov]; CISPLATIN [CTIS]; VINORELBINE [CTIS]; MYCOPHENOLATE MOFETIL [CTIS]; Datopotamab deruxtecan [CTIS]; INFLIXIMAB [CTIS]; PEMETREXED [CTIS]; ETOPOSIDE [CTIS]; CARBOPLATIN [CTIS]
Phase: Phase 3 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Active, not recruiting [CT.gov]
Enrolment: 25 (whole trial, actual) [CT.gov]
Start: 2024-10-15 (actual) [CT.gov]
Primary completion: 2026-07-10 (actual) [CT.gov]

## 39. EU CT 2023-503675-24-00
Records: CTIS 2023-503675-24-00 https://euclinicaltrials.eu/ctis-public/view/2023-503675-24-00 (access date not in this data)
Title: A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared with Investigator’s Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
Sponsor: AstraZeneca AB (Lead sponsor)
Conditions:  (MedDRA 10084066); Triple-negative Breast Cancer
Interventions: Datopotamab deruxtecan; INFLIXIMAB; MYCOPHENOLATE MOFETIL; IMFINZI 50 mg/mL concentrate for solution for infusion.; PEMBROLIZUMAB; PACLITAXEL; CARBOPLATIN; PACLITAXEL ALBUMIN-BOUND; GEMCITABINE
Phase: Phase 3
Status: Not collected yet
Enrolment: Not collected yet
Start: 2025-01-17 (status not stated)
Primary completion: No date with this role in this data

## 40. NCT05061550 · EU CT 2023-508852-21-00 · EudraCT 2021-003369-37
Records: CTIS 2023-508852-21-00 https://euclinicaltrials.eu/ctis-public/view/2023-508852-21-00 (access date not in this data); CT.gov NCT05061550 (last update posted 2026-09-23); EUCTR 2021-003369-37, member state records: FR, IT, PT, ES, BE
Registries differ on: enrolment, start
Title: A Phase II Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients with Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer (NeoCOAST-2) [EUCTR]; A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients with Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2) [CTIS]; Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer [CT.gov]
Sponsor: AstraZeneca AB (Sponsor) [EUCTR]; ASTRAZENECA AB (Sponsor) [EUCTR]; AstraZeneca AB (Lead sponsor) [CTIS]; Parexel (Collaborator) [CT.gov]; AstraZeneca (Lead sponsor) [CT.gov]
Conditions:  (MedDRA 10029519) [EUCTR, CTIS];  (MedDRA 10029520) [EUCTR, CTIS]; Cancer du poumon non à petites cellules de stade localisé (II à IIIA) opérable [EUCTR]; Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer [EUCTR];  (MedDRA 10029518) [EUCTR, CTIS]; Cancer du poumon [EUCTR]; Lung Cancer [EUCTR]; Cancro ai polmoni [EUCTR]; Cancro polmonare non a piccole cellule resecabile, in stadio precoce (da II a IIIA) [EUCTR]; Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer [CTIS, EUCTR];  (MedDRA 10029521) [CTIS, EUCTR]; Lung Neoplasms (MeSH D008175, registry index term) [CT.gov]; Non-small Cell Lung Cancer [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; Cáncer de pulmón no microcítico resecable, en estadio inicial (II a IIIA) [EUCTR]; Cáncer de pulmón [EUCTR]
Interventions: Durvalumab [EUCTR, CT.gov]; 1428935-60-7 [EUCTR]; Monalizumab [EUCTR, CTIS, CT.gov]; monalizumab [EUCTR]; 1228763-95-8 [EUCTR]; Oleclumab [EUCTR, CTIS, CT.gov]; oleclumab [EUCTR]; 1803176-05-7 [EUCTR]; Mychophenolate Mofetil 250 mg Capsules [EUCTR]; MICOFENOLATO MOFETILE [EUCTR]; Infliximab [EUCTR]; INFLIXIMAB [EUCTR]; Inflectra 100 mg powder for concentrate for solution for infusion [CTIS]; PACLITAXEL [CTIS]; AZD0171 [CTIS, CT.gov, EUCTR]; volrustomig [CTIS]; IMFINZI 50 mg/mL concentrate for solution for infusion. [CTIS]; CISPLATIN [CTIS]; Rilvegostomig [CTIS, CT.gov]; CARBOPLATIN [CTIS]; Datopotamab deruxtecan [CTIS, EUCTR]; Mycophenolate Mofetil 250 mg Capsules [CTIS]; PEMETREXED [CTIS]; Carboplatin [CT.gov]; Pemetrexed/Cisplatin [CT.gov]; Dato-DXd [CT.gov]; Carboplatin/Paclitaxel [CT.gov]; Volrustomig [CT.gov, EUCTR]; MEDI5752 [CT.gov]; MEDI4736, IMFINZI [CT.gov]; MEDI9447 [CT.gov]; Pemetrexed/Carboplatin [CT.gov]; IPH2201 [CT.gov]; Cisplatin [CT.gov]; 2407760-40-9 [EUCTR]; Falbikitug [EUCTR]; 2740565-02-8 [EUCTR]; Datopotamab Deruxtecan [EUCTR]
Phase: Phase I: No, as the registry flags it [EUCTR]; Phase 2 [CTIS, EUCTR, CT.gov]; Phase IV: No, as the registry flags it [EUCTR]; Phase III: No, as the registry flags it [EUCTR]
Status: Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Recruiting [CT.gov]; Not collected yet [CTIS]; Not mapped (Ongoing; whether it is recruiting is not stated) [EUCTR]
Enrolment: 14 (member state FR, planned) [EUCTR]; 140 (whole trial, planned) [EUCTR]; 100 (eea, planned) [EUCTR]; 26 (member state IT, planned) [EUCTR]; 630 (whole trial, estimated) [CT.gov]; 490 (whole trial, planned) [EUCTR]; 290 (eea, planned) [EUCTR]; 10 (member state PT, planned) [EUCTR]; 26 (member state ES, planned) [EUCTR]; 198 (eea, planned) [EUCTR]; 40 (member state BE, planned) [EUCTR]; 350 (whole trial, planned) [EUCTR]
Start: 2022-06-10 (status not stated) [CTIS]; 2022-04-14 (actual) [CT.gov]
Primary completion: 2030-05-28 (estimated) [CT.gov]

## 41. NCT06357533 · EU CT 2023-505077-32-00
Records: CTIS 2023-505077-32-00 https://euclinicaltrials.eu/ctis-public/view/2023-505077-32-00 (access date not in this data); CT.gov NCT06357533 (last update posted 2026-09-23)
Registries differ on: start
Title: A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig (AZD2936) or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10) [CTIS]; Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations [CT.gov]
Sponsor: AstraZeneca AB (Lead sponsor) [CTIS]; Daiichi Sankyo (Collaborator) [CT.gov]; AstraZeneca (Lead sponsor) [CT.gov]
Conditions:  (MedDRA 10061873) [CTIS]; Locally-advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. [CTIS]; Non-Small Cell Lung Cancer [CT.gov]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]
Interventions: Datopotamab deruxtecan [CTIS]; Rilvegostomig [CTIS, CT.gov]; INFLIXIMAB [CTIS]; MYCOPHENOLATE MOFETIL [CTIS]; KEYTRUDA 25 mg/mL concentrate for solution for infusion [CTIS]; Datopotamab Deruxtecan [CT.gov]; Dato-DXd [CT.gov]; Pembrolizumab [CT.gov]; KEYTRUDA [CT.gov]; AZD2936 [CT.gov]
Phase: Phase 3 [CTIS, CT.gov]
Status: Not collected yet [CTIS]; Recruiting [CT.gov]
Enrolment: 675 (whole trial, estimated) [CT.gov]
Start: 2025-01-28 (status not stated) [CTIS]; 2024-04-11 (actual) [CT.gov]
Primary completion: 2029-12-28 (estimated) [CT.gov]

## 42. EU CT 2024-518819-19-00 · EudraCT 2022-003203-14
Records: CTIS 2024-518819-19-00 https://euclinicaltrials.eu/ctis-public/view/2024-518819-19-00 (access date not in this data); EUCTR 2022-003203-14, member state records: AT
Title: Phase II Study of daTopotamab-derUXtecan (Dato-DXd; DS-1026a) in triple-negative brEast cancer patients with newly Diagnosed or prOgressing brain metastases [CTIS, EUCTR]
Sponsor: Medical University Of Vienna (Lead sponsor) [CTIS]; Med. Univ. Wien, Klinik f. Innere Medizin I, Onkologie (Sponsor) [EUCTR]
Conditions: triple negative breast cancer [CTIS]; triple negative breast cancer with newly diagnosed or progressing brain metastases [EUCTR]; triple negative breast cancer ith newly diagnosed or progressing brain metastases [EUCTR]
Interventions: Datopotamab deruxtecan [CTIS, EUCTR]; Datopotamab-Deruxtecan [EUCTR]; 2238831-60-0 [EUCTR]
Phase: Phase IV: No, as the registry flags it [EUCTR]; Phase III: No, as the registry flags it [EUCTR]; Phase I: No, as the registry flags it [EUCTR]; Phase 2 [EUCTR, CTIS]
Status: Not collected yet [CTIS]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]
Enrolment: 20 (member state AT, planned) [EUCTR]
Start: 2023-05-23 (status not stated) [CTIS]
Primary completion: No date with this role in this data

## 43. NCT03944772 · EU CT 2023-504624-25-00 · EudraCT 2018-003974-29
Records: CT.gov NCT03944772 (last update posted 2025-01-30); CTIS 2023-504624-25-00 https://euclinicaltrials.eu/ctis-public/view/2023-504624-25-00 (access date not in this data); EUCTR 2018-003974-29, member state records: NO, DK, NL, IT, SE, ES
Registries differ on: status, enrolment, start
Title: A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy [EUCTR]; Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) [CT.gov]; A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy (ORCHARD) [CTIS]
Sponsor: AstraZeneca AB (Sponsor) [EUCTR]; AstraZeneca (Lead sponsor) [CT.gov]; ASTRAZENECA AB (Sponsor) [EUCTR]; AstraZeneca AB (Lead sponsor) [CTIS]
Conditions: Advanced Non-Small Cell Lung Cancer [EUCTR, CTIS]; Non-Small Cell Lung Cancer [EUCTR, CT.gov];  (MedDRA 10061873) [EUCTR, CTIS]; Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term) [CT.gov]; carcinoma polmonare non a piccole cellule in stadio avanzato [EUCTR]; carcinoma polmonare non a piccole cellule [EUCTR];  (MedDRA 10029104) [EUCTR]; Cáncer de pulmón no microcítico avanzado [EUCTR]; Cáncer de pulmón no microcítico [EUCTR]
Interventions: Durvalumab [EUCTR, CT.gov]; durvalumab [EUCTR]; 1428935-60-7 [EUCTR]; Etoposide concentrate for solution for infusion 100mg vial (20mg/mL) [EUCTR]; Etoposide [EUCTR, CT.gov]; 33419-42-0 [EUCTR]; Selpercatinib 40 mg [EUCTR]; Selpercatinib [EUCTR, CT.gov]; 2152628-33-4 [EUCTR]; Selumetinib 25mg capsule [EUCTR]; Selumetinib [EUCTR, CT.gov]; 943332-08-9 [EUCTR]; necitumumab (Portrazza™) 800 mg concentrate for solution for infusion [EUCTR]; Necitumumab [EUCTR, CT.gov]; 906805-06-9 [EUCTR]; Savolitinib [EUCTR, CT.gov]; 1313725-88-0 [EUCTR]; Alectinib 150 mg capsules [EUCTR]; Alectinib [EUCTR, CT.gov]; 1256580-46-7 [EUCTR]; carboplatin 10 mg/mL intravenous infusion [EUCTR]; Carboplatin [EUCTR, CT.gov]; 41575-94-4 [EUCTR]; Cisplatin [EUCTR, CT.gov]; 15663-27-1 [EUCTR]; Osimertinib [EUCTR, CT.gov]; 1421373-66-1 [EUCTR]; Iressa [EUCTR, CT.gov]; Gefitinib [EUCTR, CT.gov]; 184475-35-2 [EUCTR]; Datopotamab deruxtecan [EUCTR, CT.gov, CTIS]; pemetrexed 500 mg powder for concentrate for solution for infusion [EUCTR]; Pemetrexed disodium [EUCTR]; 150399-23-8 [EUCTR]; Selpercatinib 80 mg [EUCTR]; Koselugo [CT.gov]; Alecensa [CT.gov]; Portrazza [CT.gov]; DS 1062a [CT.gov]; Loxo-292, Retevmo, Retsevmo [CT.gov]; TAGRISSO [CT.gov]; IMFINZI [CT.gov]; Pemetrexed [CT.gov]; ALECTINIB [EUCTR]; Cisplatine [EUCTR]; Carboplatin 10 mg/mL per infusione endovenosa [EUCTR]; CARBOPLATINO [EUCTR]; antihistamines [EUCTR]; pemetrexed 500 mg polvere per concentrato per soluzione per infusione [EUCTR]; PEMETREXED DISODICO [EUCTR]; Datopotamab Deruxtecan [EUCTR]; Osimertinib 80 mg compressa rivestita con film [EUCTR]; CISPLATINO [EUCTR]; Alectinib 150 mg capsule [EUCTR]; Vitamina B12 [EUCTR]; VITAMINA B12 [EUCTR]; na [EUCTR]; Osimertinib 40 mg compresse rivestite con film [EUCTR]; Inflectra 100 mg powder for concentrate for solution for infusion [EUCTR, CTIS]; INFLIXIMAB [EUCTR]; Etoposide concentrato per soluzione per infusione flaconcino da 100 mg (20 mg/mL) [EUCTR]; ETOPOSIDE [EUCTR, CTIS]; Acido folico [EUCTR]; ACIDO FOLICO [EUCTR]; Selumetinib capsule da 25 mg [EUCTR]; Micofenolato mofetile [EUCTR]; MICOFENOLATO MOFETILE [EUCTR]; Acetaminophen [EUCTR]; Glucocorticoids [EUCTR]; Etopodise [EUCTR]; CARBOPLATIN [CTIS]; Koselugo 25 mg hard capsules [CTIS]; CISPLATIN [CTIS]; TAGRISSO 40 mg film-coated tablets [CTIS]; Mycophenolate Mofetil Accord 250 mg capsules [CTIS]; IMFINZI 50 mg/mL concentrate for solution for infusion. [CTIS]; TAGRISSO 80 mg film-coated tablets [CTIS]
Phase: Phase 2 [EUCTR, CTIS, CT.gov]; Phase III: No, as the registry flags it [EUCTR]; Phase IV: No, as the registry flags it [EUCTR]; Phase I: No, as the registry flags it [EUCTR]
Status: Completed [EUCTR]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]; Active, not recruiting [CT.gov]; Not mapped (Ongoing; whether it is recruiting is not stated) [EUCTR]; Not collected yet [CTIS]
Enrolment: 8 (member state NO, planned) [EUCTR]; 280 (whole trial, planned) [EUCTR]; 81 (eea, planned) [EUCTR]; 182 (whole trial, planned) [EUCTR]; 79 (eea, planned) [EUCTR]; 11 (member state DK, planned) [EUCTR]; 247 (whole trial, actual) [CT.gov]; 30 (member state NL, planned) [EUCTR]; 12 (member state IT, planned) [EUCTR]; 12 (member state SE, planned) [EUCTR]; 18 (member state ES, planned) [EUCTR]; 150 (whole trial, planned) [EUCTR]
Start: 2019-06-25 (actual) [CT.gov]; 2019-09-26 (status not stated) [CTIS]
Primary completion: 2025-05-06 (estimated) [CT.gov]

## 44. NCT07738341
Records: CT.gov NCT07738341 (last update posted 2026-07-31)
Title: GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)
Sponsor: Eddingpharm (Zhuhai) Co., Ltd. (Lead sponsor)
Conditions: Diabetes Mellitus, Insulin-Dependent, 12 (MeSH C563326, registry index term); Breast Neoplasms (MeSH D001943, registry index term); Neoplasm Metastasis (MeSH D009362, registry index term); Breast Cancer (Locally Advanced or Metastatic)
Interventions: Nab-Paclitaxel; Sacituzumab Tirumotecan; Datopotamab Deruxtecan (Dato-DXd); GB268
Phase: Phase 1; Phase 2
Status: Not yet recruiting
Enrolment: 270 (whole trial, estimated)
Start: 2026-08-01 (estimated)
Primary completion: 2029-08-01 (estimated)

## 45. NCT07825753
Records: CT.gov NCT07825753 (last update posted 2026-09-17)
Title: Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer
Sponsor: Fudan University (Lead sponsor)
Conditions: Breast Neoplasms (MeSH D001943, registry index term); Advanced or Metastatic Pancreatic Adenocarcinoma; Pancreatic Neoplasms (MeSH D010190, registry index term); Advanced or Metastatic Breast Cancer (BC)
Interventions: Datopotamab deruxtecan (Dato-DXd); Mirvetuximab soravtansine (MIRV); Izalontamab brengitecan (iza-bren / BL-B01D1); Becotatug vedotin (MRG003); Trastuzumab emtansine (T-DM1); Enfortumab vedotin (EV); Sacituzumab govitecan (SG); Trastuzumab deruxtecan (T-DXd)
Phase: Phase 2
Status: Not yet recruiting
Enrolment: 225 (whole trial, estimated)
Start: 2026-09-10 (estimated)
Primary completion: 2027-09-01 (estimated)

## 46. NCT06533826
Records: CT.gov NCT06533826 (last update posted 2026-08-26)
Title: TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Sponsor: AstraZeneca (Collaborator); Ana C Garrido-Castro, MD (Lead sponsor); Translational Breast Cancer Research Consortium (Collaborator)
Conditions: HER2-low Breast Cancer; Breast Cancer; HER2-negative Breast Cancer; Breast Neoplasms (MeSH D001943, registry index term); Metastatic Breast Cancer
Interventions: Datopotamab Deruxtecan; Dato-DXd; DS-1062; DS-1062a; Trastuzumab Deruxtecan; Enhertu; am-trastuzumab deruxtecan-nxki; T-DXd; DS-8201a
Phase: Phase 2
Status: Recruiting
Enrolment: 357 (whole trial, estimated)
Start: 2024-10-29 (actual)
Primary completion: 2028-01-01 (estimated)

## 47. NCT06176261
Records: CT.gov NCT06176261 (last update posted 2026-08-06)
Title: DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
Sponsor: Daiichi Sankyo (Collaborator); Nancy Lin, MD (Lead sponsor)
Conditions: HER2 Negative Breast Carcinoma; Metastatic Triple-Negative Breast Carcinoma; ER-negative Breast Cancer; ER Positive Breast Cancer; HER2-negative Breast Cancer; Breast Cancer Female; Breast Cancer; Breast Neoplasms (MeSH D001943, registry index term); Triple Negative Breast Neoplasms (MeSH D064726, registry index term)
Interventions: Datopotamab Deruxtecan; DS-1062; DS-1062a, Dato-DXd
Phase: Phase 2
Status: Recruiting
Enrolment: 58 (whole trial, estimated)
Start: 2024-01-08 (actual)
Primary completion: 2028-01-01 (estimated)

## 48. EU CT 2023-505924-71-00 · EudraCT 2020-005723-37
Records: CTIS 2023-505924-71-00 https://euclinicaltrials.eu/ctis-public/view/2023-505924-71-00 (access date not in this data); EUCTR 2020-005723-37, member state records: FR
Title: Phase 2, Open label Study of DS-1062a, an Anti-TROP-2-Antibody-Drug Conjugate (ADC), in patients with advanced and/or unresectable Non-Small Cell Lung Cancer (NSCLC), with biomarker analysis to characterize response to therapy [EUCTR]
Sponsor: Gustave Roussy (Sponsor) [EUCTR]; Institut Gustave Roussy (Lead sponsor) [CTIS]
Conditions: Adult patients with metastatic and/or unresectable Non-Small Cell Lung Cancer (NSCLC) who progressed on at least one line and not more than three lines of prior therapy for metastatic/unresectable NSCLC [EUCTR, CTIS]; Patients with metastatic and / or unresectable non-small cell lung cancer who have progressed on at least 1 line and no more than 3 lines of previous treatment [EUCTR];  (MedDRA 10061873) [EUCTR, CTIS]
Interventions: Datopotamab deruxtecan [EUCTR]
Phase: Phase III: No, as the registry flags it [EUCTR]; Phase 2 [EUCTR, CTIS]; Phase I: No, as the registry flags it [EUCTR]; Phase IV: No, as the registry flags it [EUCTR]
Status: Not collected yet [CTIS]; Not mapped (The trial moved to CTIS under the Clinical Trials Regulation) [EUCTR]
Enrolment: 100 (member state FR, planned) [EUCTR]
Start: 2021-05-12 (status not stated) [CTIS]
Primary completion: No date with this role in this data

## 49. EU CT 2024-520101-39-00
Records: CTIS 2024-520101-39-00 https://euclinicaltrials.eu/ctis-public/view/2024-520101-39-00 (access date not in this data)
Title: A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
Sponsor: AstraZeneca AB (Lead sponsor)
Conditions: TROP2 NMR-positive advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.
Interventions: Datopotamab deruxtecan; DOCETAXEL
Phase: Phase 3
Status: Not collected yet
Enrolment: Not collected yet
Start: 2026-04-01 (status not stated)
Primary completion: No date with this role in this data

## 50. NCT06822543
Records: CT.gov NCT06822543 (last update posted 2026-08-26)
Title: A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
Sponsor: Latin American Cooperative Oncology Group (Lead sponsor); AstraZeneca (Collaborator); Merck Sharp & Dohme LLC (Collaborator)
Conditions: Lung Neoplasms (MeSH D008175, registry index term); Brain Neoplasms (MeSH D001932, registry index term); Carcinoma, Non-Small-Cell Lung (MeSH D002289, registry index term); Brain Metastases; Non Small Cell Lung Cancer; Lung Cancer
Interventions: Pembrolizumab; Datopotamab deruxtecan; Carboplatin
Phase: Phase 2
Status: Recruiting
Enrolment: 46 (whole trial, estimated)
Start: 2025-09-12 (actual)
Primary completion: 2028-06-30 (estimated)