Clinical Trial: NCT04205812
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Incyte Corporation |
| Information Provided By: | Incyte Corporation |
| Last Update Posted: | 2026-07-06 |
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
Official Title
A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)
Conditions
Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: Retifanlimab
- Drug: Placebo
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: nab-Paclitaxel
Other Study ID Numbers
- INCMGA 0012-304
- 2022-501987-16-00
- 2019-003372-39
- 2019
Start Date (Actual)
2020-09-11
Primary Completion Date (Actual)
2023-12-15
Study Completion Date (Actual)
2026-05-28
Enrollment (Actual)
583
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Incyte Corporation |
| Information Provided By: | Incyte Corporation |
| Last Update Posted: | 2026-07-06 |
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
Official Title
A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)
Conditions
Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: Retifanlimab
- Drug: Placebo
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: nab-Paclitaxel
Other Study ID Numbers
- INCMGA 0012-304
- 2022-501987-16-00
- 2019-003372-39
- 2019
Start Date (Actual)
2020-09-11
Primary Completion Date (Actual)
2023-12-15
Study Completion Date (Actual)
2026-05-28
Enrollment (Actual)
583
Study Type
Interventional
Phase
Phase 3