Study identifier:D926FC00001
ClinicalTrials.gov identifier:NCT04612751
EudraCT identifier:2021-000274-28
CTIS identifier:N/A
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)
Advanced or Metastatic NSCLC
Phase 1
No
Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Durvalumab, Durvalumab, Durvalumab, Durvalumab, Carboplatin, Carboplatin, Carboplatin, Carboplatin, Carboplatin, Carboplatin, AZD2936, AZD2936, AZD2936, AZD2936, MEDI5752, MEDI5752, MEDI5752
All
232
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2023 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Datopotamab deruxtecan (Dato-DXd) + Durvalumab | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Durvalumab Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Imfinzi |
Experimental: Cohort 2 Datopotamab deruxtecan (Dato-DXd) + Durvalumab | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Durvalumab Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Imfinzi |
Experimental: Cohort 3 Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Durvalumab Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Imfinzi Drug: Carboplatin Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle |
Experimental: Cohort 4 Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Durvalumab Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Imfinzi Drug: Carboplatin Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle |
Experimental: Cohort 5 Datopotamab deruxtecan (Dato-DXd) + AZD2936 | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: AZD2936 Intravenous infusion prior to Dato-DXd |
Experimental: Cohort 6 Datopotamab deruxtecan (Dato-DXd) + AZD2936 | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: AZD2936 Intravenous infusion prior to Dato-DXd |
Experimental: Cohort 7 Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Carboplatin Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle Drug: AZD2936 Intravenous infusion prior to Dato-DXd |
Experimental: Cohort 8 Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Carboplatin Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle Drug: AZD2936 Intravenous infusion prior to Dato-DXd |
Experimental: Cohort 9 Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Carboplatin Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle Drug: MEDI5752 Intravenous infusion prior to Dato-DXd |
Experimental: Cohort 10 Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: Carboplatin Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle Drug: MEDI5752 Intravenous infusion prior to Dato-DXd |
Experimental: Cohort 11 Datopotamab deruxtecan (Dato-DXd) + MEDI5752 | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: MEDI5752 Intravenous infusion prior to Dato-DXd |