14 recruiting, 11 active not recruiting, 1 approved for marketing, 1 not yet recruiting. 12 Phase 3, 11 Phase 2, 8 Phase 1.
By phase and status
Follow Dato-DXd: new trials by email Literature Review of Dato-DXd trials Research Report on Dato-DXd
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
TROPION Breast Respond in 1L TNBC Dato-DXd - Unresectable Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer Not yet recruiting Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company 400 2027-03-01 2026-10-09 A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)] Dato-DXd, Enfortumab Vedotin (EV), Pembrolizumab - Urothelial Cancer, Non-small Cell Lung Cancer Phase 1 / Phase 2 Recruiting Daiichi Sankyo 268 2026-10-16 2026-10-22 An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC Dato-DXd, Rilvegostomig, Durvalumab - High-risk Muscle Invasive Urothelial Carcinoma Phase 3 Recruiting AstraZeneca 915 2026-07-16 2026-07-22 A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer Ivonescimab, Dato-DXd, Osimertinib - Non-Small Cell Lung Cancer Phase 1 / Phase 2 Recruiting Memorial Sloan Kettering Cancer Center 66 2026-04-09 2026-07-13 PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease Datopotamab deruxtecan, Circulating tumor DNA (ctDNA) testing - Breast Cancer, Residual Disease Phase 2 Recruiting UNC Lineberger Comprehensive Cancer Center 78 2026-02-26 2026-04-22 A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer Dato-DXd - Breast Cancer Phase 3 Recruiting AstraZeneca 100 2025-10-30 2026-10-02 Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Dato-DXd, Carboplatin, Cisplatin - Urothelial Cancer, Bladder Cancer Phase 2 / Phase 3 Recruiting Daiichi Sankyo 630 2025-09-26 2026-08-20 A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) Rilvegostomig, Ramucirumab, Dato-DXd - Non-Small Cell Lung Cancer Phase 2 Recruiting AstraZeneca 278 2025-08-07 2026-10-15 TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd Trastuzumab Deruxtecan, Datopotamab Deruxtecan - Breast Cancer, HER2-low Breast Cancer Phase 2 Recruiting Ana C Garrido-Castro, MD 357 2024-10-29 2026-08-26 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 Dato-DXd, Osimertinib, Pemetrexed - Metastatic Non-small Cell Lung Cancer Phase 3 Active not recruiting AstraZeneca 768 2024-10-04 2026-10-15 A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer Dato-DXd, Durvalumab - Breast Cancer Phase 1 / Phase 2 Recruiting Gustave Roussy, Cancer Campus, Grand Paris 50 2024-07-05 2024-07-22 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 Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab - Non-Small Cell Lung Cancer Phase 3 Recruiting AstraZeneca 675 2024-04-11 2026-09-23 A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors Valemetostat tosylate, T-DXd, Dato-DXd - Advanced Solid Tumor Phase 1 Active not recruiting Daiichi Sankyo 210 2024-02-22 2026-09-15 A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors AZD3470, Datopotamab deruxtecan - Advanced Solid Tumors That Are MTAP Deficient Phase 1 / Phase 2 Recruiting AstraZeneca 334 2024-01-18 2026-08-27 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) Dato-DXd, Durvalumab, Paclitaxel - Breast Cancer Phase 3 Recruiting AstraZeneca 625 2023-11-23 2026-09-25 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 Dato-DXd, Durvalumab, Pembrolizumab - Breast Cancer Phase 3 Active not recruiting AstraZeneca 1902 2023-11-14 2026-10-21 Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) Datopotamab Deruxtecan, Pembrolizumab, Pemetrexed - Metastatic Non Small Cell Lung Cancer Phase 3 Active not recruiting Daiichi Sankyo 1170 2023-01-11 2026-06-23 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) Dato-DXd, Durvalumab, Capecitabine - Breast Cancer Phase 3 Active not recruiting AstraZeneca 1174 2022-11-28 2026-10-14 A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) Dato-DXd, Paclitaxel, Nab-paclitaxel - Breast Cancer Phase 3 Active not recruiting AstraZeneca 644 2022-05-16 2026-05-15 Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer Durvalumab, Oleclumab, Monalizumab - Non-small Cell Lung Cancer Phase 2 Recruiting AstraZeneca 630 2022-04-14 2026-10-21
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Conditions studied Breast Neoplasms (11) · Carcinoma, Non-Small-Cell Lung (11) · Neoplasm Metastasis (5) · Triple Negative Breast Neoplasms (4) · Urinary Bladder Neoplasms (3) · Carcinoma (2) · Carcinoma, Transitional Cell (2) · Biliary Tract Neoplasms (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Hemangiosarcoma (1) · Lung Neoplasms (1) · Neoplasm, Residual (1) · Neoplasms (1) · Ovarian Neoplasms (1)
Sponsors AstraZeneca (14) · Daiichi Sankyo (7) · Ana C Garrido-Castro, MD (1) · Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · Memorial Sloan Kettering Cancer Center (1) · QuantumLeap Healthcare Collaborative (1) · UNC Lineberger Comprehensive Cancer Center (1)
Countries United States (24) · Italy (18) · Japan (17) · Spain (17) · China (16) · France (15) · South Korea (15) · Taiwan (15) · Canada (13) · Germany (11) · Poland (11) · United Kingdom (11) · Australia (10) · Belgium (10) · Brazil (10)
Top investigators Ana Garrido-Castro, MD (1) · Barbara Pistillli, MD (1) · Helena Yu, MD (1) · Laura Esserman, MD, MBA (1) · Suresh S. Ramalingam, MD (1) · Timothy Yap (1) · Tina Cascone, MD (1) · Yara Abdou, MD (1)
Results publications PMID 21796368 , PMID 22198468 , PMID 22623692 , PMID 22649152 , PMID 27406346 , PMID 27406347 , PMID 28851423 , PMID 32031889 , PMID 32053137 , PMID 32450725 , PMID 32701140 , PMID 34529000 , PMID 34741021 , PMID 35623341 , PMID 35929986 , PMID 35993306 , PMID 36069821 , PMID 36456573 , PMID 37029329 , PMID 37249038 , PMID 37325931 , PMID 37387213 , PMID 37505107 , PMID 37526149 , PMID 38086377 , PMID 38180338 , PMID 38686016 , PMID 38745646 , PMID 39158353 , PMID 39265124 , PMID 39277671 , PMID 39277672 , PMID 39469838 , PMID 39613746 , PMID 39625569 , PMID 39917260 , PMID 40297626 , PMID 40450142 , PMID 40526879 , PMID 40551254 , PMID 40639409 , PMID 40679371 , PMID 40777112 , PMID 41466843 , PMID 41669261 , PMID 41871716 , PMID 41879562 , PMID 42142358 , PMID 42530945 , PMID 42545411
NIH funding 2023 (9), 2025 (1)