At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Retifanlimab, Placebo, and 5 other interventions for Metastatic Squamous Non-Small Cell Lung Cancer and Metastatic Nonsquamous Non-Small Cell Lung Cancer. Completed, enrolled 583 participants across 140 sites in 17 countries.
Signals
Detailed 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).
Study Details
Timeline
Arms & Interventions
INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.
INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.
Interventions
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.