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)

INCMGA 0012-304

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).

2020-09-11

2023-12-15

2025-04-15

Active (not recruiting)

Early phase I

583

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)

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2024-05-16