Lung Cancer Clinical Trial
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
Summary
This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Adequate hematologic and end-organ function
Exclusion Criteria:
Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Pregnant or lactating women
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Positive test for Human Immunodeficiency Virus (HIV)
Active hepatitis B or hepatitis C
Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
Severe infection within 4 weeks prior to randomization
Significant history of cardiovascular disease
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There are 136 Locations for this study
La Jolla California, 92093, United States
New Haven Connecticut, 06520, United States
Boca Raton Florida, 33428, United States
Baltimore Maryland, 21201, United States
Portland Oregon, 97239, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37204, United States
Fredericksburg Virginia, 22408, United States
Seattle Washington, 98108, United States
Salvador BA, 41820, Brazil
Cachoeiro de Itapemirim ES, 29308, Brazil
Rio de Janeiro RJ, 20560, Brazil
Ijui RS, 98700, Brazil
Passo Fundo RS, 99010, Brazil
Porto Alegre RS, 90020, Brazil
Porto Alegre RS, 90610, Brazil
Joinville SC, 89201, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 08270, Brazil
São Paulo SP, 01246, Brazil
Harbin City , 15008, China
Angers , 49933, France
Clamart , 92141, France
Limoges , 87042, France
Montpellier , 34070, France
Nancy , 54100, France
Paris , 75020, France
Saint Denis Cedex , 97405, France
Saint-Mande , 94160, France
Saint-pierre , 97448, France
Strasbourg , 67000, France
Gauting , 82131, Germany
Oldenburg , 26121, Germany
Athens , 11527, Greece
Athens , 155 6, Greece
Athens , 185 4, Greece
Chaidari , 124 6, Greece
Larissa , 412 2, Greece
Patras , 265 0, Greece
Thermi, Thessaloniki , 57001, Greece
Thessaloniki , 546 2, Greece
Thessaloniki , 54645, Greece
Thessaloniki , 564 2, Greece
Thessaloniki , 57010, Greece
Budapest , 1145, Hungary
Nyiregyhaza , 4400, Hungary
Pecs , 7624, Hungary
Szolnok , 5004, Hungary
Meldola Emilia-Romagna, 47014, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Bergamo Lombardia, 24100, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20141, Italy
Monza Lombardia, 20052, Italy
Monza Lombardia, 20052, Italy
Rozzano (MI) Lombardia, 20089, Italy
Torino Piemonte, 10126, Italy
Catania Sicilia, 95123, Italy
Verona Veneto, 37126, Italy
Aichi , 464-8, Japan
Aichi , 466-8, Japan
Fukuoka , 812-8, Japan
Hokkaido , 060-8, Japan
Hyogo , 650-0, Japan
Hyogo , 673-8, Japan
Ibaraki , 309-1, Japan
Miyagi , 980-0, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Osaka , 573-1, Japan
Osaka , 583-8, Japan
Sakai-shi , 591-8, Japan
Satima , 362-0, Japan
Tokyo , 104-0, Japan
Tokyo , 160-0, Japan
Jeollanam-do , 58128, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03181, Korea, Republic of
Gdansk , , Poland
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Poznan , 60-56, Poland
Poznan , 60-69, Poland
Brasov , 50009, Romania
Cluj Napoca , 40001, Romania
Craiova , 20034, Romania
Iasi , 70048, Romania
Sibiu , 55024, Romania
Timi?oara , 30021, Romania
Timisoara , 30023, Romania
Arkhangelsk Arhangelsk, 16304, Russian Federation
Obninsk Kaluga, 24903, Russian Federation
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow Moskovskaja Oblast, 10522, Russian Federation
St. Petersburg Sankt Petersburg, 19401, Russian Federation
Kazan Tatarstan, 42002, Russian Federation
Ryazan , 39004, Russian Federation
Saransk , 43003, Russian Federation
St Petersburg , 19429, Russian Federation
St Petersburg , 19708, Russian Federation
Volgograd , 40013, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Sremska Kamenica , 21204, Serbia
Badalona Barcelona, 08916, Spain
Castellon DE LA Plana/castello DE LA Plana Castellon, 12002, Spain
Palma de Mallorca Islas Baleares, 07010, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
Coruna LA Coruña, 15006, Spain
Barakaldo Vizcaya, 48903, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Jaen , 23007, Spain
Madrid , 28040, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Zaragoza , 50009, Spain
Hat Yai , 90110, Thailand
Khon Kaen , 40002, Thailand
Muang , 57000, Thailand
Phitsanulok , 65000, Thailand
Adana , 1330, Turkey
Ankara , 06100, Turkey
Istanbul , 34000, Turkey
Izmir , 35100, Turkey
Izmir , 35110, Turkey
Malatya , 44280, Turkey
Kharkiv Kharkiv Governorate, 61070, Ukraine
Odesa Kherson Governorate, 65055, Ukraine
Sumy Kholm Governorate, 40005, Ukraine
Dnipro KIEV Governorate, 49102, Ukraine
Kyiv KIEV Governorate, 02096, Ukraine
Vinnytsia KIEV Governorate, 21029, Ukraine
Lutsk Volhynian Governorate, 43018, Ukraine
Kirovograd , 25006, Ukraine
Birmingham , B9 5S, United Kingdom
Colchester, Essex , CO4 5, United Kingdom
Manchester , M20 3, United Kingdom
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