Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

NCT04205812 ↗

Phase 3 Completed 583 enrolled Incyte Corporation

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2020-09-11
Primary completion: 2023-12-15
Completion: 2026-05-28

Publications

Lu S, Vynnychenko O, Kulyaba Y, Kuchava V, Ibrahim A, Moiseenko F, Arslan C, Nguyen DT, Petrovic M, Cicin I, Bibichadze K, Cil T, Shi J, Olmez OF, Gogishvili M, Artac M, Nguyen HG, Cornfeld M, Tian C, Munteanu MC, Sette CVM, Bondarenko I; POD1UM-304 Study Team. Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study. Lancet Respir Med. 2025 Dec;13(12):1096-1107. doi: 10.1016/S2213-2600(25)00209-7. Epub 2025 Sep 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Retifanlimab	Monoclonal antibody	375 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

Summary

Timeline

Publications

Drugs

Indications