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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo + Chemotherapy vs Retifanlimab + Chemotherapy; p = 0.0042; Hazard Ratio (HR) 0.75 (95% CI 0.60 to 0.93) NCT04205812 ↗

paper Median overall survival was longer in the retifanlimab plus chemotherapy group than in the placebo plus chemotherapy group PMID 40983066 ↗

release “The POD1UM-304 trial results show a clinically meaningful and statistically significant improvement over chemotherapy alone.” incyte.com ↗

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	Nab-paclitaxel	Small molecule	100 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications