Lung Cancer Clinical Trial
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
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).
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)
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There are 126 Locations for this study
Anaheim California, 92801, United States
Whittier California, 90603, United States
Reading Pennsylvania, 19612, United States
Barretos , 14784, Brazil
Caxias Do Sul , 95010, Brazil
Fortaleza , 60336, Brazil
Ijui , 98700, Brazil
Itajai , 88301, Brazil
Londrina , 86015, Brazil
Passo Fundo , 99010, Brazil
Porto Alegre , 90470, Brazil
Rio de Janeiro , 20230, Brazil
S?O Paulo , 03102, Brazil
Santo Andre , 09060, Brazil
Sao Jose , 15090, Brazil
Sofia , 01330, Bulgaria
Sofia , 01407, Bulgaria
Sofia , 01431, Bulgaria
Sofia , 01632, Bulgaria
Sofia , 01797, Bulgaria
Varna , 09002, Bulgaria
Changsha , 41001, China
Guangzhou , 51008, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Harbin , 15008, China
Hefei , 23000, China
Hefei , 23060, China
Jinan , 25001, China
Linyi , 27600, China
Nanchang , 33000, China
Nanning , 53002, China
Shanghai , 20003, China
Tianjing , 30005, China
Urumqi , 83000, China
Zhengzhou , 45000, China
Zhengzhou , 45000, China
Zhengzhou , 45005, China
Hradec Kralove , 50333, Czechia
Olomouc , 775 2, Czechia
Ostrava - Vitkovice , 703 8, Czechia
Praha 5 , 150 0, Czechia
Batumi , 06000, Georgia
Kutaisi , 04600, Georgia
Tbilisi , 00102, Georgia
Tbilisi , 00112, Georgia
Tbilisi , 00114, Georgia
Tbilisi , 00141, Georgia
Tbilisi , 00141, Georgia
Tbilisi , 00144, Georgia
Tbilisi , 00159, Georgia
Tbilisi , 00177, Georgia
Budapest , 01121, Hungary
Kecskemet , 06000, Hungary
Kepala Batas , 13200, Malaysia
Kuala Lumpur , 59100, Malaysia
Kuantan , 25100, Malaysia
Kuching , 93586, Malaysia
Petaling Jaya , 46050, Malaysia
Pulau Pinang , 10990, Malaysia
Putrajaya , 62250, Malaysia
Cebu City , 06000, Philippines
Davao City , 08000, Philippines
Iloilo City , 05000, Philippines
Makati City , 01229, Philippines
Makati , 01229, Philippines
Manila , 01000, Philippines
Muntinlupa , 01781, Philippines
Pasig City , 01605, Philippines
Quezon City , 01102, Philippines
Biala Podlaska , 21-50, Poland
Konin , 62-50, Poland
Krakow , 30-36, Poland
Lodz , 90-24, Poland
Poznan , 60-69, Poland
Baia Mare , 43029, Romania
Cluj Napoca , 40001, Romania
Cluj-napoca , 40013, Romania
Constanta , 90059, Romania
Timisoara , 30016, Romania
Timisoara , 30023, Romania
Arkhangelsk , 16304, Russian Federation
Kursk , 30503, Russian Federation
Moscow , 12130, Russian Federation
Nizniy Novgorod , 60308, Russian Federation
Novosibirsk , 63010, Russian Federation
Omsk , 64401, Russian Federation
Saint-petersburg , 19702, Russian Federation
Saint-petersburg , 19775, Russian Federation
St Petersburg , 19775, Russian Federation
Volgograd , 40013, Russian Federation
Belgrade , 11 00, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrad , 11000, Serbia
Kragujevac , 34000, Serbia
Sremska Kamenica , 21204, Serbia
Cape Town , 07570, South Africa
Cape Town , 07700, South Africa
Johannesburg , 02193, South Africa
Johannesburg , 02196, South Africa
Pretoria , 00002, South Africa
Pretoria , 00181, South Africa
Adana , 01130, Turkey
Adana , 01230, Turkey
Ankara , 06100, Turkey
Ankara , 06105, Turkey
Ankara , 06520, Turkey
Ankara , 06800, Turkey
Antalya , 07020, Turkey
Edirne , 22030, Turkey
Gaziantep , 27310, Turkey
Istanbul , 34098, Turkey
Istanbul , 34147, Turkey
Istanbul , 34214, Turkey
Izmir , 35530, Turkey
Konya , 42080, Turkey
Malatya , 44280, Turkey
Dnipro , 49102, Ukraine
Ivano-frankivsk , 76018, Ukraine
Kharkiv , 61070, Ukraine
Kharkiv , 61103, Ukraine
Kherson , 73000, Ukraine
Kropyvnytskyi , 25006, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03115, Ukraine
Kyiv , 03126, Ukraine
Kyiv , 04107, Ukraine
Lutsk , 43018, Ukraine
Sumy , 40022, Ukraine
Uzhgorod , 88000, Ukraine
Zaporizhzhia , 69059, Ukraine
Can Tho , 00000, Vietnam
Hanoi , 00000, Vietnam
Hanoi , 10000, Vietnam
Hanoi , 10000, Vietnam
Hanoi , 10000, Vietnam
Hanoi , 10000, Vietnam
Ho Chi Minh City , 72268, Vietnam
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