Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
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).
Checked against the public recordLast updated Jul 6, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: Retifanlimab; Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: nab-Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8). * No prior systemic treatment for the advanced/metastatic NSCLC * Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy * Measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least 3 months. * Willingness to avoid pregnancy or fathering children. * Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening. Exclusion Criteria: * Clinically significant cardiac disease within 6 months of start of study treatment. * Any major surgery within 3 weeks of the first dose of study treatment. * Thoracic radiation therapy of \> 30 Gy within 6 months of the first dose of study treatment. * History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel. * Untreated central nervous system metastases and/or carcinomatous meningitis. * Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids. * Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained. * Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers. * Has contraindications to chemotherapy agents used in the study. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment. * Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug). Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained. • Has known active HBV or HCV (testing must be performed to determine eligibility)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Pacific Cancer Medical CenterAnaheim, California
- Innovative Clinical Research InstituteWhittier, California
- Reading Hospital and Medical CenterReading, Pennsylvania
- Fundacao Pio Xii Hospital de Cancer de BarretosBarretos
- Incan - Instituto Do Cancer - Hospital PompeiaCaxias do Sul
- Centro Regional Integrado de OncologiaFortaleza
- Oncosite - Centro de Pesquisa Clinica E OncologiaIjuí
- Clinica de Neoplasias Litoral LtdaItajaí
- Hospital Do Cancer de LondrinaLondrina
- Instituto Mederi de Pesquisa E SaudePasso Fundo
- Hgb - Hospital Giovanni Battista - Mae de Deus CenterPorto Alegre
- Inca - Instituto Nacional de CancerRio de Janeiro
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2026. Always confirm current availability with the study team.