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

Conditions

• Metastatic Nonsquamous Non-Small Cell Lung Cancer
• Metastatic Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Retifanlimab — DRUG
  INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
• Placebo — DRUG
  Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
• Pemetrexed — DRUG
  Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
• Cisplatin — DRUG
  Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
• Carboplatin — DRUG
  Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
• Paclitaxel — DRUG
  Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
• nab-Paclitaxel — DRUG
  nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.

Study Details

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).

Key Dates

Start date

Sep 11, 2020

Status verified

Mar 2026

Primary completion

Dec 15, 2023

Completion

Aug 28, 2026

Study Design

Enrollment

583 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: INCMGA00012 + chemotherapy (nonsquamous NSCLC)
  INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
• Active Comparator: Placebo + chemotherapy (nonsquamous NSCLC)
  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.
• Experimental: INCMGA00012 + chemotherapy (squamous NSCLC)
  INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
• Active Comparator: Placebo + chemotherapy (squamous NSCLC)
  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.

Primary Outcome Measure

Overall Survival [ Time Frame: up to 39.1 months ]

Locations (3)

Find similar trials in Anaheim, CA