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, Durvalumab, Carboplatin, AZD2936, MEDI5752
All
232
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 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 |