Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (POD1UM-304)
Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Metastatic Squamous Non-Small Cell Lung Cancer focused on measuring Metastatic, non-small cell lung cancer, nonsquamous, squamous, PD-1, PD-L1
Eligibility Criteria
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)
Sites / Locations
- Pacific Cancer Medical Center
- Innovative Clinical Research Institute
- Reading Hospital and Medical Center
- Fundacao Pio Xii Hospital de Cancer de Barretos
- Incan - Instituto Do Cancer - Hospital Pompeia
- Centro Regional Integrado de Oncologia
- Oncosite - Centro de Pesquisa Clinica E Oncologia
- Clinica de Neoplasias Litoral Ltda
- Hospital Do Cancer de Londrina
- Instituto Mederi de Pesquisa E Saude
- Hgb - Hospital Giovanni Battista - Mae de Deus Center
- Inca - Instituto Nacional de Cancer
- Sao Camilo Oncologia
- Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
- Mc Women'S Health-Nadezhda Eood
- Acibadem Cityclinica Mhat Tokuda
- Umhat Sv. Ivan Rilski Ead
- Mhat Serdika Eood
- Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
- Shatod Dr Marko Marko - Varna Ltd
- Hunan Cancer Hospital
- The First Affiliated Hospital Sun Yat-Sen University
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
- Hangzhou Cancer Hospital
- The First Affiliated Hospital of Zhejiang University
- Zhejiang Cancer Hospital
- Harbin Medical University Cancer Hospital
- University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
- The Second Hospital of Anhui Medical University
- Jinan Central Hospital
- Linyi Cancer Hospital
- The Second Affiliated Hospital of Nanchang University
- The First Affiliated Hospital of Guangxi Medical University
- Shanghai Chest Hospital
- General Hospital of Tianjin
- The Affiliated Cancer Hospital of Xinjiang Medical University
- Henan Cancer Hostipal
- Henan Provincial Peoples Hospital
- The First Affiliated Hospital of Zhengzhou University
- University Hospital Hradec Kralove
- Fakultni Nemocnice Olomouc
- Nemocnice Agel Ostrava - Vitkovice A.S
- Fakultni Nemocnice V Motole
- High Technology Hospital Medcenter
- Jsc Evex Hospitals
- Archangel St. Michael Multi Profile Clinical Hospital
- Israel-Georgian Medical Research Clinic Helsicore
- New Hospitals
- Medulla Chemotherapy and Immunotherapy Clinic
- Tbilisi State Medical University First University Clinic
- High Technology Medical Center, University Clinic
- Institute of Clinical Oncology Ltd
- Cancer Research Center Ltd
- Orszagos Koranyi Tbc Es Pulmonological Intezet
- Bacs Kiskun Megyei Oktatokorhaz
- Advanced Medical and Dental Institute Husm
- University Malaya Medical Centre
- Hospital Tengku Ampuan Afzan
- Sarawak General Hospital
- Beacon Hospital Sdn Bhd
- Hospital Pulau Pinang
- Institut Kanser Negara - National Cancer Institute
- Cebu Doctors University Hospital
- Davao Doctors Hospital
- West Visayas State University Medical Center
- Makati Medical Center
- Makati Medical Center
- Philippine General Hospital
- Asian Hospital and Medical Center
- The Medical City
- St. Lukes Medical Center
- Ko-Med Centra Kliniczne Biala Podlaska
- Przychodnia Lekarska Komed
- Centrum Medyczne Plejady
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
- Przychodnia Med-Polonia Sp. Z O.O.
- S.C Oncopremium Team S.R.L
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
- Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
- Spitalul Clinic Judetean de Urgenta Constanta
- S C Oncocenter Oncologie Medicala S R L
- Oncomed Srl
- Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
- Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
- Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
- Llc Tonus
- Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
- Bhi of Omsk Region Clinical Oncology Dispensary
- Pavlov First Saint Petersburg State Medical University
- N.N. Petrov Research Institute of Oncology
- N.N. Petrov Research Institute of Oncology
- Sbhi Volgograd Regional Onclogy Dispensary
- Clinical Center of Serbia
- Clinical Center Bezanijska Kosa
- Clinical Center of Serbia
- Oncomed-System
- Clinical Center Kragujevac
- Institute For Pulmonary Diseases of Vojvodina
- Cape Town Oncology Trials (Pty) Ltd
- Cancercare Rondebosch Oncology Centre
- Wits Clinical Research
- Sandton Oncology Centre
- University of Pretoria Oncology Department
- Mary Potter Oncology Centre
- Acibadem Adana Hospital
- Adana Sehir Hastanesi
- Hacettepe Universitesi Tip Fakultesi Hastanesi
- Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
- Memorial Ankara Hospital
- Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
- Memorial Antalya Hastanesi
- Trakya Universitesi Tip Fakultesi
- Gaziantep University Gaziantep Oncology Hospital
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
- Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
- Medipol University Medical Faculty
- Izmir Medicalpark Hospital
- Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
- Inonu Universitesi Turgut Ozal Tip Merkezi
- Multifield Clinical Hospital No 4
- Ci Carpathian Clinical Oncological Center
- Communal Non-Profit Enterprise Regional Center of Oncology
- V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
- Kherson Regional Oncologic Dispensary
- Pp Ppc Acinus Medical and Diagnostic Centre
- Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
- Kyiv City Clinical Oncological Center
- Medical Center Asklepion Llc
- Ci of Krc Kyiv Regional Oncologic Dispensary
- Volyn Regional Oncological Dispensary
- Rmi Sumy Regional Clinical Oncology Dispensary
- Cne Ccch of Uzh Cc Oncological Center
- Medical Center Oncolife Llc
- Can Tho Oncology Hospital
- 103 Military Hospital
- Bach Mai Hospital
- Hanoi Oncology Hospital
- National Cancer Hospital
- National Lung Hospital
- Hcmc Oncology Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
INCMGA00012 + chemotherapy (nonsquamous NSCLC)
Placebo + chemotherapy (nonsquamous NSCLC)
INCMGA00012 + chemotherapy (squamous NSCLC)
Placebo + chemotherapy (squamous NSCLC)
INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
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.
INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
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.