Lung Cancer Clinical Trial
A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)
Summary
This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed Stage IV squamous NSCLC
Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
No prior treatment for Stage IV squamous NSCLC
Measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic and end-organ function
Exclusion Criteria:
Active or untreated central nervous system (CNS) metastases
Untreated or inadequately treated spinal cord compression
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites
Uncontrolled tumor-related pain
Uncontrolled hypercalcemia
Any other malignancies within 5 years except those with negligible risk of metastasis or death
Pregnant or lactating women
Known hypersensitivity to any component of atezolizumab formulation or other study medication
History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
Prior allogeneic bone marrow or solid organ transplantation
Positive human immunodeficiency virus (HIV) test
Active hepatitis B or C
Active tuberculosis
Significant cardiovascular disease
Severe infection or major surgery within 4 weeks prior to randomization
Use of any approved anti-cancer therapy within 3 weeks prior to treatment
Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
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There are 80 Locations for this study
Encinitas California, 92008, United States
Greenbrae California, 94904, United States
La Jolla California, 92093, United States
Orange California, 92868, United States
Norwich Connecticut, 06360, United States
Washington District of Columbia, 20007, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32803, United States
Honolulu Hawaii, 96813, United States
Harvey Illinois, 60426, United States
Louisville Kentucky, 40207, United States
Baltimore Maryland, 21201, United States
Easton Maryland, 21601, United States
Missoula Montana, 59802, United States
Summit New Jersey, 07902, United States
Bronx New York, 10467, United States
Brooklyn New York, 11219, United States
Charlotte North Carolina, 28204, United States
Hickory North Carolina, 28602, United States
Pinehurst North Carolina, 28374, United States
Hershey Pennsylvania, 17033, United States
Spartanburg South Carolina, 29303, United States
Bristol Tennessee, 37620, United States
Chattanooga Tennessee, 37403, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37232, United States
Auburn Washington, 98002, United States
Morgantown West Virginia, 26506, United States
Pardubice , 532 0, Czechia
Limoges , 87042, France
Paris , 75970, France
Strasbourg , 67085, France
Hannover , 30459, Germany
Paderborn , 33098, Germany
Athens , 11527, Greece
Athens , 12464, Greece
Thessaloniki , 546 2, Greece
Thessaloniki , 57010, Greece
Budapest , 1083, Hungary
Budapest , 1145, Hungary
Matrahaza , 3233, Hungary
Nyiregyhaza , 4400, Hungary
Pecs , 7624, Hungary
Szolnok , 5000, Hungary
Meldola Emilia-Romagna, 47014, Italy
Rimini Emilia-Romagna, 47900, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Bergamo Lombardia, 24100, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Monza Lombardia, 20900, Italy
Rozzano (MI) Lombardia, 20089, Italy
Torino Piemonte, 10126, Italy
Verona Veneto, 37126, Italy
Gyeonggi-do , 13620, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Suwon-si, , 442-7, Korea, Republic of
Gdansk , 80-21, Poland
Alba Iulia , 51007, Romania
Baia Mare , 43003, Romania
Brasov , 50009, Romania
Craiova , 20034, Romania
Iasi , 70048, Romania
Sibiu , 55024, Romania
Timisoara , 30023, Romania
Arkhangelsk , 16304, Russian Federation
Kursk , 30503, Russian Federation
Nizhny Novgorod , 60308, Russian Federation
Saransk , 43003, Russian Federation
St Petersburg , 19429, Russian Federation
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Sremska Kamenica , 21204, Serbia
Badalona Barcelona, 08916, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Birmingham , B9 5S, United Kingdom
Grimsby , DN33 , United Kingdom
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
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