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

NCT04205812 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 583

Last updated 2026-03-31

Study results available
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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).

Conditions

Interventions

DRUG

Retifanlimab

INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

DRUG

Placebo

Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

DRUG

Pemetrexed

Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.

DRUG

Cisplatin

Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

DRUG

Carboplatin

Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

DRUG

Paclitaxel

Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

DRUG

nab-Paclitaxel

nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.

Sponsors & Collaborators

Principal Investigators

  • Incyte Medical Monitor · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2023-12-15
Completion
2026-08-28
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Bulgaria
  • China
  • Czechia
  • Georgia
  • Hungary
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205812 on ClinicalTrials.gov