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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT04205812

Run by

Incyte Corporation

People needed

583

Starts

2020-09-11

Expected to finish

2026-05-28

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Innovative Clinical Research Institute — Whittier, California, United States
• Reading Hospital and Medical Center — Reading, Pennsylvania, United States
• Fundacao Pio Xii Hospital de Cancer de Barretos — Barretos, Brazil
• Incan - Instituto Do Cancer - Hospital Pompeia — Caxias do Sul, Brazil
• Centro Regional Integrado de Oncologia — Fortaleza, Brazil
• Oncosite - Centro de Pesquisa Clinica E Oncologia — Ijuí, Brazil
• Clinica de Neoplasias Litoral Ltda — Itajaí, Brazil
• Hospital Do Cancer de Londrina — Londrina, Brazil
• Instituto Mederi de Pesquisa E Saude — Passo Fundo, Brazil
• Hgb - Hospital Giovanni Battista - Mae de Deus Center — Porto Alegre, Brazil
• Inca - Instituto Nacional de Cancer — Rio de Janeiro, Brazil
• Sao Camilo Oncologia — S?O Paulo, Brazil
• Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia — Santo André, Brazil
• Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto — São José, Brazil
• Mc Women'S Health-Nadezhda Eood — Sofia, Bulgaria
• Acibadem Cityclinica Mhat Tokuda — Sofia, Bulgaria
• Umhat Sv. Ivan Rilski Ead — Sofia, Bulgaria
• Mhat Serdika Eood — Sofia, Bulgaria
• Multiprofile Hospital For Active Treatment Central Onco Hospital Ood — Sofia, Bulgaria
• Shatod Dr Marko Marko - Varna Ltd — Varna, Bulgaria
• Hunan Cancer Hospital — Changsha, China
• The First Affiliated Hospital Sun Yat-Sen University — Guangzhou, China
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China
• Hangzhou Cancer Hospital — Hangzhou, China
• Pacific Cancer Medical Center — Anaheim, California, United States

Full record on ClinicalTrials.gov

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