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).

View Eligibility Criteria

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)

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT04205812

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 141 Locations for this study

See Locations Near You

Pacific Cancer Medical Center
Anaheim California, 92801, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Instituto de Investigaciones Metabolicas (Idim)
Ciudad Autonoma Buenos Aires , C1012, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Cordoba , 05016, Argentina
Sanatorio Parque S.A.
Rosario , S2000, Argentina
Cer San Juan Centro Polivalente de Asistencia E Inv. Clinica
San Juan , 05400, Argentina
Centro Medico San Roque S.R.L.
San Miguel de Tucuman , 04000, Argentina
Clinicas Viedma S.A.
Viedma , R8500, Argentina
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos , 14784, Brazil
Incan - Instituto Do Cancer - Hospital Pompeia
Caxias Do Sul , 95010, Brazil
Centro Regional Integrado de Oncologia
Fortaleza , 60336, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
IJU , 98700, Brazil
Clinica de Neoplasias Litoral Ltda
Itaja , 88301, Brazil
Hospital Do Cancer de Londrina
Londrina , 86015, Brazil
Instituto Mederi de Pesquisa E Saude
Passo Fundo , 99010, Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre , 90470, Brazil
Inca - Instituto Nacional de Cancer
Rio de Janeiro , 20230, Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo ANDR , 09060, Brazil
A. C. Camargo Cancer Center
Santo Paulo , 01509, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose , 15090, Brazil
Sao Camilo Oncologia
S�O Paulo , 03102, Brazil
Mc Women'S Health-Nadezhda Eood
Sofia , 01330, Bulgaria
Acibadem Cityclinica Mhat Tokuda
Sofia , 01407, Bulgaria
Umhat Sv. Ivan Rilski Ead
Sofia , 01431, Bulgaria
Mhat Serdika Eood
Sofia , 01632, Bulgaria
Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
Sofia , 01797, Bulgaria
Shatod Dr Marko Marko - Varna Ltd
Varna , 09002, Bulgaria
Hunan Cancer Hospital
Changsha , 41001, China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou , 51008, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou , 31000, China
Hangzhou Cancer Hospital
Hangzhou , 31000, China
The First Affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
Zhejiang Cancer Hospital
Hangzhou , 31002, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei , 23000, China
The Second Hospital of Anhui Medical University
Hefei , 23060, China
Jinan Central Hospital
Jinan , 25001, China
Linyi Cancer Hospital
Linyi , 27600, China
The Second Affiliated Hospital of Nanchang University
Nanchang , 33000, China
The First Affiliated Hospital of Guangxi Medical University
Nanning , 53002, China
Shanghai Chest Hospital
Shanghai , 20003, China
General Hospital of Tianjin
Tianjing , 30005, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Urumqi , 83000, China
Henan Cancer Hostipal
Zhengzhou , 45000, China
Henan Provincial Peoples Hospital
Zhengzhou , 45000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou , 45005, China
University Hospital Hradec Kralove
Hradec Kralove , 50333, Czechia
Fakultni Nemocnice Olomouc
Olomouc , 775 2, Czechia
Nemocnice Agel Ostrava - Vitkovice A.S
Ostrava - Vitkovice , 703 8, Czechia
Fakultni Nemocnice V Motole
Praha 5 , 150 0, Czechia
High Technology Hospital Medcenter
Batumi , 06000, Georgia
Jsc Evex Hospitals
Kutaisi , 04600, Georgia
Archangel St. Michael Multi Profile Clinical Hospital
Tbilisi , 00102, Georgia
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi , 00112, Georgia
New Hospitals
Tbilisi , 00114, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi , 00141, Georgia
Tbilisi State Medical University First University Clinic
Tbilisi , 00141, Georgia
HIGH TECHNOLOGY MEDICAL�CENTER, UNIVERSITY CLINIC
Tbilisi , 00144, Georgia
Institute of Clinical Oncology Ltd
Tbilisi , 00159, Georgia
Cancer Research Center Ltd
Tbilisi , 00177, Georgia
Orszagos Koranyi Tbc Es Pulmonological Intezet
Budapest , 01121, Hungary
Bacs Kiskun Megyei Oktatokorhaz
Kecskemet , 06000, Hungary
Advanced Medical and Dental Institute Husm
Kepala Batas , 13200, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan , 25100, Malaysia
Sarawak General Hospital
Kuching , 93586, Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya , 46050, Malaysia
Hospital Pulau Pinang
Pulau Pinang , 10990, Malaysia
Institut Kanser Negara - National Cancer Institute
Putrajaya , 62250, Malaysia
Centro Oncologico de Chihuahua (Coc)
Chihuahua , 31217, Mexico
Investigacion Onco Farmaceutica S. de R.L. de C.V. (Oncotech)
La Paz , 23040, Mexico
Health Pharma Professional Research S.A. de C.V.
Mexico City , 03810, Mexico
Coi Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico , 04700, Mexico
Axis Heilsa S. de R.L. de C.V.
Monterrey , 64060, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey , 64460, Mexico
Clinical Medical Research S.C.
Orizaba , 94300, Mexico
Oncologico Potosino
SAN LUIS Potos , 78250, Mexico
Cebu Doctors University Hospital
Cebu City , 06000, Philippines
Davao Doctors Hospital
Davao City , 08000, Philippines
West Visayas State University Medical Center
Iloilo City , 05000, Philippines
Makati Medical Center
Makati City , 01229, Philippines
Makati Medical Center
Makati , 01229, Philippines
Philippine General Hospital
Manila , 01000, Philippines
Asian Hospital and Medical Center
Muntinlupa , 01781, Philippines
The Medical City
Pasig City , 01605, Philippines
St. Lukes Medical Center
Quezon City , 01102, Philippines
Ko-Med Centra Kliniczne Biala Podlaska
Biala Podlaska , 21-50, Poland
Przychodnia Lekarska Komed
Konin , 62-50, Poland
Centrum Medyczne Plejady
KRAK�W , 30-36, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
Lodz , 90-24, Poland
Przychodnia Med-Polonia Sp. Z O.O.
Poznan , 60-69, Poland
S.C Oncopremium Team S.R.L
Baia Mare , 43029, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj Napoca , 40001, Romania
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
Cluj-napoca , 40013, Romania
Spitalul Clinic Judetean de Urgenta Constanta
Constanta , 90059, Romania
S C Oncocenter Oncologie Medicala S R L
Timisoara , 30016, Romania
Oncomed Srl
Timisoara , 30023, Romania
Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk , 16304, Russian Federation
Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
Kursk , 30503, Russian Federation
Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
Moscow , 12130, Russian Federation
Llc Tonus
Nizniy Novgorod , 60308, Russian Federation
Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
Novosibirsk , 63010, Russian Federation
Bhi of Omsk Region Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
Pavlov First Saint Petersburg State Medical University
Saint-petersburg , 19702, Russian Federation
N.N. Petrov Research Institute of Oncology
Saint-petersburg , 19775, Russian Federation
N.N. Petrov Research Institute of Oncology
St Petersburg , 19775, Russian Federation
Sbhi Volgograd Regional Onclogy Dispensary
Volgograd , 40013, Russian Federation
Clinical Center of Serbia
Belgrade , 11 00, Serbia
Clinical Center Bezanijska Kosa
Belgrade , 11000, Serbia
Clinical Center of Serbia
Belgrade , 11000, Serbia
Oncomed-System
Belgrad , 11000, Serbia
Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Institute For Pulmonary Diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
Cape Town Oncology Trials (Pty) Ltd
Cape Town , 07570, South Africa
Cancercare Rondebosch Oncology Centre
Cape Town , 07700, South Africa
Wits Clinical Research
Johannesburg , 02193, South Africa
Sandton Oncology Centre
Johannesburg , 02196, South Africa
University of Pretoria Oncology Department
Pretoria , 00002, South Africa
Mary Potter Oncology Centre
Pretoria , 00181, South Africa
Acibadem Adana Hospital
Adana , 01130, Turkey
Adana Sehir Hastanesi
Adana , 01230, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara , 06100, Turkey
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
Ankara , 06105, Turkey
Memorial Ankara Hospital
Ankara , 06520, Turkey
Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
Ankara , 06800, Turkey
Memorial Antalya Hastanesi
Antalya , 07020, Turkey
Trakya Universitesi Tip Fakultesi
Edirne , 22030, Turkey
Gaziantep University Gaziantep Oncology Hospital
Gaziantep , 27310, Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
Istanbul , 34147, Turkey
Medipol University Medical Faculty
Istanbul , 34214, Turkey
Izmir Medicalpark Hospital
Izmir , 35530, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya , 42080, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya , 44280, Turkey
Multifield Clinical Hospital No 4
Dnipro , 49102, Ukraine
Ci Carpathian Clinical Oncological Center
Ivano-frankivsk , 76018, Ukraine
Communal Non-Profit Enterprise Regional Center of Oncology
Kharkiv , 61070, Ukraine
V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
Kharkiv , 61103, Ukraine
Kherson Regional Oncologic Dispensary
Kherson , 73000, Ukraine
Pp Ppc Acinus Medical and Diagnostic Centre
Kropyvnytskyi , 25006, Ukraine
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih , 50048, Ukraine
Kyiv City Clinical Oncological Center
Kyiv , 03115, Ukraine
Medical Center Asklepion Llc
Kyiv , 03126, Ukraine
Ci of Krc Kyiv Regional Oncologic Dispensary
Kyiv , 04107, Ukraine
Volyn Regional Oncological Dispensary
Lutsk , 43018, Ukraine
Rmi Sumy Regional Clinical Oncology Dispensary
Sumy , 40022, Ukraine
Cne Ccch of Uzh Cc Oncological Center
Uzhgorod , 88000, Ukraine
Medical Center Oncolife Llc
Zaporizhzhia , 69059, Ukraine
Can Tho Oncology Hospital
Can Tho , 00000, Vietnam
103 Military Hospital
Hanoi , 00000, Vietnam
Bach Mai Hospital
Hanoi , 10000, Vietnam
Hanoi Oncology Hospital
Hanoi , 10000, Vietnam
National Cancer Hospital
Hanoi , 10000, Vietnam
National Lung Hospital
Hanoi , 10000, Vietnam
Hcmc Oncology Hospital
Ho Chi Minh City , 72268, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT04205812

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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