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    DRUG:

    Datroway (datopotamab deruxtecan)

    i
    Company:
    AstraZeneca, Daiichi Sankyo
    Drug class:
    Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
    Related drugs:
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    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) (NCT04526691)
    Phase 1
    Daiichi Sankyo
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    09/15/2020
    Primary completion :
    04/15/2026
    Completion :
    04/15/2026
    EGFR • KRAS • BRAF • ALK • ROS1 • PD-L2 • NTRK • TACSTD2
    |
    KRAS mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Datroway (datopotamab deruxtecan)
    Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1) (NCT05417594)
    Phase 1/2
    AstraZeneca
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    06/24/2022
    Primary completion :
    08/28/2026
    Completion :
    08/28/2026
    HER-2 • BRCA1 • BRCA2 • IDH1 • IDH2 • HRD • BRCA • RAD51C • RAD51D
    |
    HER-2 negative • PALB2 mutation • RAD51C mutation • RAD51D mutation
    |
    temozolomide • Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan) • AZD9574
    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) (NCT04656652)
    Phase 3
    Daiichi Sankyo
    Active, not recruiting
    Last update posted :
    02/13/2025
    Initiation :
    12/21/2020
    Primary completion :
    05/10/2024
    Completion :
    06/21/2025
    EGFR • PD-L1 • BRAF • ALK • MET • RET • ROS1 • NTRK
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET exon 14 mutation
    |
    docetaxel • Datroway (datopotamab deruxtecan)
    Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2) (NCT05061550)
    Phase 2
    AstraZeneca
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    04/14/2022
    Primary completion :
    05/09/2030
    Completion :
    05/09/2030
    EGFR • PD-L1 • ALK
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan) • oleclumab (MEDI9447) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
    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 (TROPION-Breast04) (NCT06112379)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    02/06/2025
    Initiation :
    11/14/2023
    Primary completion :
    03/29/2028
    Completion :
    08/28/2030
    HER-2
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • paclitaxel • doxorubicin hydrochloride • capecitabine • cyclophosphamide • epirubicin • Datroway (datopotamab deruxtecan)
    Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04) (NCT04612751)
    Phase 1
    AstraZeneca
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    02/02/2021
    Primary completion :
    01/30/2026
    Completion :
    01/30/2026
    EGFR • PD-L1 • ALK
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • Datroway (datopotamab deruxtecan) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    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 (TROPION-Lung10) (NCT06357533)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    04/11/2024
    Primary completion :
    04/24/2028
    Completion :
    05/24/2030
    PD-L1 • TACSTD2
    |
    TROP2 positive
    |
    Keytruda (pembrolizumab) • Datroway (datopotamab deruxtecan) • rilvegostomig (AZD2936)
    Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations (AVANZAR) (NCT05687266)
    Phase 3
    AstraZeneca
    Active, not recruiting
    Last update posted :
    01/30/2025
    Initiation :
    12/29/2022
    Primary completion :
    11/01/2027
    Completion :
    11/01/2027
    EGFR • BRAF • ALK • ROS1 • TACSTD2
    |
    EGFR mutation • ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan) • Pemfexy (pemetrexed)
    Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (Tropion-Lung08) (NCT05215340)
    Phase 3
    Daiichi Sankyo
    Recruiting
    Last update posted :
    12/13/2024
    Initiation :
    03/04/2022
    Primary completion :
    02/29/2028
    Completion :
    04/30/2028
    EGFR • PD-L1 • KRAS • BRAF • ALK • RET • ROS1 • TACSTD2
    |
    PD-L1 expression • KRAS mutation
    |
    Keytruda (pembrolizumab) • Datroway (datopotamab deruxtecan)
    First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01) (NCT03401385)
    Phase 1
    Daiichi Sankyo Co., Ltd.
    Active, not recruiting
    Last update posted :
    12/03/2024
    Initiation :
    01/31/2018
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    HER-2 • ER • PGR • ERBB3 • CD4 • TACSTD2
    |
    HER-2 positive • HR positive • HER-2 negative • HER-2 expression
    |
    Datroway (datopotamab deruxtecan)
    Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) (NCT05555732)
    Phase 3
    Daiichi Sankyo
    Recruiting
    Last update posted :
    11/12/2024
    Initiation :
    01/11/2023
    Primary completion :
    08/01/2027
    Completion :
    08/01/2027
    EGFR • PD-L1 • BRAF • ALK • RET • ROS1 • TACSTD2
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan) • Pemfexy (pemetrexed)
    I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY 2) (NCT01042379)
    Phase 2
    QuantumLeap Healthcare Collaborative
    Recruiting
    Last update posted :
    10/22/2024
    Initiation :
    03/01/2010
    Primary completion :
    12/01/2030
    Completion :
    12/01/2031
    HER-2 • ER
    |
    ER positive • ER negative
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • Zejula (niraparib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • Datroway (datopotamab deruxtecan) • Ziihera (zanidatamab-hrii) • ganitumab (AMG 479) • amcenestrant (SAR439859) • anvatabart opadotin (JNJ-0683) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • vepdegestrant (ARV-471) • Cosela (trilaciclib) • Fablyn (lasofoxifene) • DAN-222 • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • rilvegostomig (AZD2936) • trebananib (AMG 386) • Kevzara (sarilumab) • Voyager-V1
    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) (NCT06103864)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    11/23/2023
    Primary completion :
    09/01/2026
    Completion :
    04/23/2029
    PD-L1
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Datroway (datopotamab deruxtecan)
    A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (BEGONIA) (NCT03742102)
    Phase 1/2
    AstraZeneca
    Recruiting
    Last update posted :
    05/21/2024
    Initiation :
    12/21/2018
    Primary completion :
    11/14/2024
    Completion :
    11/14/2024
    HER-2 • PD-L1
    |
    PD-L1 expression • HER-2 expression • PD-L1 expression + HER-2 overexpression
    |
    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Truqap (capivasertib) • Datroway (datopotamab deruxtecan) • oleclumab (MEDI9447)
    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) (NCT05104866)
    Phase 3
    AstraZeneca
    Active, not recruiting
    Last update posted :
    04/23/2024
    Initiation :
    10/18/2021
    Primary completion :
    08/15/2025
    Completion :
    08/15/2025
    HER-2
    |
    HER-2 negative
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • Datroway (datopotamab deruxtecan)
    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) (NCT05460273)
    Phase 1/2
    AstraZeneca
    Active, not recruiting
    Last update posted :
    04/17/2024
    Initiation :
    07/11/2022
    Primary completion :
    11/07/2023
    Completion :
    05/06/2024
    EGFR • HER-2 • ALK • PGR • ROS1 • TACSTD2
    |
    HER-2 negative • HER-2 expression • PGR negative
    |
    Datroway (datopotamab deruxtecan)
    Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) (NCT04484142)
    Phase 2
    Daiichi Sankyo
    Active, not recruiting
    Last update posted :
    04/09/2024
    Initiation :
    03/30/2021
    Primary completion :
    03/10/2023
    Completion :
    12/31/2024
    EGFR • KRAS • BRAF • ALK • MET • ROS1 • NTRK
    |
    KRAS mutation • EGFR mutation • MET exon 14 mutation
    |
    Datroway (datopotamab deruxtecan)
    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) (NCT05374512)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    03/21/2024
    Initiation :
    05/16/2022
    Primary completion :
    12/03/2025
    Completion :
    12/03/2025
    HER-2 • PGR
    |
    PD-L1 expression • PD-L1 negative
    |
    carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • Datroway (datopotamab deruxtecan)
    Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases (TUXEDO-2) (NCT05866432)
    Phase 2
    Medical University of Vienna
    Recruiting
    Last update posted :
    10/19/2023
    Initiation :
    07/01/2023
    Primary completion :
    05/23/2026
    Completion :
    05/23/2026
    PD-L1
    |
    HR negative
    |
    Datroway (datopotamab deruxtecan)
    Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer (ICARUS-LUNG01) (NCT04940325)
    Phase 2
    Gustave Roussy, Cancer Campus, Grand Paris
    Recruiting
    Last update posted :
    06/25/2021
    Initiation :
    05/12/2021
    Primary completion :
    11/12/2022
    Completion :
    11/12/2025
    EGFR • BRAF • ALK • MET • ROS1 • NTRK
    |
    EGFR mutation • BRAF mutation • RET mutation • MET mutation • NTRK fusion
    |
    Datroway (datopotamab deruxtecan)