Study identifier:D926FC00001
ClinicalTrials.gov identifier:NCT04612751
EudraCT identifier:2021-000274-28
CTIS identifier:2023-505992-54-00
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, AZD7789
All
371
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
Daiichi Sankyo
This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
The primary objective is to assess the safety and tolerability of Dato-DXd in combination with immunotherapy with or without 4 cycles of carboplatin in participants with advanced or metastatic NSCLC. Two dose levels of Dato-DXd will be studied in combination with immunotherapy (durvalumab, AZD2936, MEDI5752, or AZD7789) with or without 4 cycles of carboplatin in 15 study cohorts Each cohort will start with Part 1 (dose escalation or confirmation), where 3 to 9 participants will be assessed for dose-limiting toxicities (DLT) in the first cycle of treatment. if the DLT incidence rate meets the criteria based on the modified toxicity probability interval-2 (mTPI-2), then Part 2 (dose expansion) may be opened.
Location
Status
Location
Cleveland, OH, United States, 44106
Status
Recruiting
Location
Santa Ana, CA, United States, 92705
Status
Completed
Location
Hackensack, NJ, United States, 07601
Status
Recruiting
Location
Koto-ku, Japan, 135-8550
Status
Recruiting
Location
Saint Louis, MO, United States, 63110
Status
Recruiting
Location
San Antonio, TX, United States, 78229
Status
Recruiting
Location
Dallas, TX, United States, 75230
Status
Completed
Location
Paris Cedex 05, France, 75248
Status
Withdrawn
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Datopotamab deruxtecan (Dato-DXd) + Durvalumab in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy | 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 in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy | 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 in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy | 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 in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy | 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 in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: rilvegostomig |
Experimental: Cohort 6 Datopotamab deruxtecan (Dato-DXd) + AZD2936 in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: rilvegostomig |
Experimental: Cohort 7 Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: rilvegostomig |
Experimental: Cohort 8 Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: rilvegostomig |
Experimental: Cohort 9 Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: volrustomig |
Experimental: Cohort 10 Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: volrustomig |
Experimental: Cohort 11 Datopotamab deruxtecan (Dato-DXd) + MEDI5752 in participants with treatment-naïve NSCLC | 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 every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: volrustomig |
Experimental: Cohort 12 Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: AZD7789 Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: sabestomig |
Experimental: Cohort 13 Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: AZD7789 Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: sabestomig |
Experimental: Cohort 14 Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with treatment-naïve NSCLC | Drug: Datopotamab deruxtecan Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle Other Name: Dato-DXd Drug: AZD7789 Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle Other Name: sabestomig |
Experimental: Cohort 4A Datopotamab deruxtecan (Dato-DXd) + Durvalumab + carboplatin in participants with treatment-naïve NSCLC | 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 |
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