Lung Cancer Clinical Trial
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
Summary
This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are eligible if the major histological component appears to be non-squamous
No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and ALK status require test results at screening from a local or central laboratory
Participants who have received prior neo-adjuvant, radiotherapy, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy
Participants should submit a pre-treatment tumor tissue sample if available before or within 4 weeks after enrollment. If tumor tissue is not available, participants are still eligible
For participants enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end organ function
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of cisplatin
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Exclusion Criteria:
Cancer-Specific Exclusions
Participants with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than or equal to (>= 2) weeks prior to randomization
Leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper limit of normal)
Malignancies other than NSCLC within 5 years prior to randomization
Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not eligible are excluded)
General Medical Exclusions:
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
History of certain autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
All participants will be tested for human immunodeficiency virus (HIV) prior to the inclusion into the study and HIV-positive participants will be excluded from the clinical study
Severe infections within 4 weeks prior to randomization
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
Exclusion Criteria Related to Medications and Chemotherapy:
Prior treatment with EGFR inhibitors or ALK inhibitors
Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to initiation of study treatment
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
Treatment with systemic immunosuppressive medications
Exclusion Criteria Related to Chemotherapy:
History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
Participants with hearing impairment (cisplatin)
Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)
Creatinine clearance (CRCL) <60 milliliters/minute (mL/min) for cisplatin or <45 mL/min for carboplatin
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There are 180 Locations for this study
Los Angeles California, 90017, United States
Sebastopol California, 95472, United States
Stamford Connecticut, 06904, United States
Orlando Florida, 32806, United States
Tallahassee Florida, 32308, United States
Atlanta Georgia, 30342, United States
Harvey Illinois, 60426, United States
Peoria Illinois, 61615, United States
Tinley Park Illinois, 60487, United States
Fort Wayne Indiana, 46845, United States
Goshen Indiana, 46526, United States
Lexington Kentucky, 40536, United States
Ann Arbor Michigan, 48109, United States
Grand Island Nebraska, 68803, United States
Omaha Nebraska, 68114, United States
Bronx New York, 10461, United States
Cary North Carolina, 27513, United States
Portland Oregon, 97213, United States
Gettysburg Pennsylvania, 17325, United States
Pittsburgh Pennsylvania, 15212, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Newport News Virginia, 23601, United States
Roanoke Virginia, 24014, United States
Seattle Washington, 98195, United States
Green Bay Wisconsin, 54311, United States
Buenos Aires , 00001, Argentina
Cordoba , X5002, Argentina
Viedma , R8500, Argentina
Darlinghurst New South Wales, 2010, Australia
Sydney New South Wales, 2076, Australia
Sydney New South Wales, 2217, Australia
Redcliffe Queensland, 4020, Australia
South Brisbane Queensland, 4101, Australia
Hobart Tasmania, 7000, Australia
Ballarat Victoria, 3350, Australia
Frankston Victoria, 3199, Australia
Geelong Victoria, 3220, Australia
Wels , 4600, Austria
Gent , 9000, Belgium
Herstal , 4040, Belgium
Roeselare , 8800, Belgium
Sofia , 1303, Bulgaria
Santiago , 75000, Chile
Temuco , 48104, Chile
Viña del Mar , 25206, Chile
Beijing Shi , 10005, China
Beijing , 10014, China
Changsha CITY , 41001, China
Changzhou , 21300, China
Guangzhou , 51012, China
Hangzhou City , 31000, China
Hangzhou City , 31001, China
Hefei , 23000, China
Hefei , 23008, China
Jinan City , 25001, China
Nanjing City , 21002, China
Shanghai , 20000, China
Shanghai , 20003, China
Shenyang , 11000, China
Tianjing , 30006, China
Tianjin , 30005, China
Wuhan City , 43003, China
Wuhan , 43002, China
Zhejiang , 31002, China
Avignon , 84082, France
Bron , 69677, France
Clermont-ferrand , 63003, France
Creteil , 94010, France
Limoges , 87039, France
Marseille , 13015, France
Montpellier , 34298, France
Mulhouse , 68070, France
Saint-Mande , 94160, France
Toulon , 83041, France
Farkasgyepu , 8582, Hungary
Gyor , 9024, Hungary
Szombathely , 9700, Hungary
Székesfehérvár , 8000, Hungary
Torokbalint , 2045, Hungary
Dublin , 7, Ireland
Dublin , 8, Ireland
Ashkelon , 78306, Israel
Holon , 58220, Israel
Petach Tiqwa , 49414, Israel
Parma Emilia-Romagna, 43126, Italy
Ravenna Emilia-Romagna, 48100, Italy
Roma Lazio, 00144, Italy
Roma Lazio, 00161, Italy
Orbassano (TO) Piemonte, 10043, Italy
Lecce Puglia, 73044, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Taormina Sicilia, 98039, Italy
Lucca Toscana, 55100, Italy
Aichi , 460-0, Japan
Chiba , 277-8, Japan
Hiroshima , 734-8, Japan
Hokkaido , 070-8, Japan
Hyogo , 670-8, Japan
Ishikawa , 920-8, Japan
Kagoshima , 890-8, Japan
Kanagawa , 241-8, Japan
Miyagi , 980-8, Japan
Niigata , 951-8, Japan
Osaka , 565-0, Japan
Osaka , 569-8, Japan
Saga , 849-8, Japan
Tokushima , 770-8, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Tokyo , 141-8, Japan
Yamaguchi , 755-0, Japan
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Riga , LV-10, Latvia
Panevezys , 35144, Lithuania
Kepala Batas Penang, 13200, Malaysia
Kuala Lumpur , 50586, Malaysia
Breda , 4819 , Netherlands
Den Haag , 2547 , Netherlands
EDE , 6716 , Netherlands
Harderwijk , 3844 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Tilburg , 5042A, Netherlands
Lima , 31, Peru
Loures , 2674-, Portugal
Matosinhos , 4454-, Portugal
Senhora Da Hora - Porto , 4460-, Portugal
Cluj-Napoca , 40005, Romania
Constanta , 90059, Romania
Iasi , 70010, Romania
Chelyabinsk Moskovskaja Oblast, 45408, Russian Federation
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Yaroslavl , 15004, Russian Federation
Elche Alicante, 03203, Spain
Badalona Barcelona, 08916, Spain
L Hospitalet De Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 8208, Spain
Mataro Cantabria, 08304, Spain
Donostia Guipuzcoa, 20014, Spain
A Coruna LA Coruña, 15009, Spain
El Palmar Murcia, 30120, Spain
Pamplona Navarra, 31008, Spain
Pamplona Navarra, 31008, Spain
Seville Sevilla, 41014, Spain
Alicante , 03010, Spain
Barcelona , 08025, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Burgos , 09006, Spain
Girona , 17007, Spain
Lugo , 27003, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Valencia , 46009, Spain
Valencia , 46026, Spain
Dalin, Chiayi , 622, Taiwan
Kaohsiung , 824, Taiwan
Liuying Township , 736, Taiwan
Taipei City , 112, Taiwan
Taipei , 100, Taiwan
Taipei , 11490, Taiwan
Dnipropetrovsk Katerynoslav Governorate, 49102, Ukraine
Kyiv Kharkiv Governorate, 02096, Ukraine
Cherkasy , 18009, Ukraine
Kirovograd , 25006, Ukraine
Sumy , 40022, Ukraine
Zaporizhzhya , 69040, Ukraine
Bristol , BS2 8, United Kingdom
Cardiff , CF14 , United Kingdom
Glasgow , G12 0, United Kingdom
Inverness , IV2 3, United Kingdom
London , SW17 , United Kingdom
London , W6 8R, United Kingdom
Oxford , OX3 7, United Kingdom
Plymouth , PL6 8, United Kingdom
Romford , RM7 0, United Kingdom
Truro , TR1 3, United Kingdom
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