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)

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 578
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 00001428
    • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • Cordoba, Argentina, X5002AOQ
    • Fundacion Clinica Colombo
  • Viedma, Argentina, R8500ACE
    • Clinica Viedma S.A.
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
    • Sydney, New South Wales, Australia, 2076
      • Sydney Adventist Hospital; Clinical Trial Unit
    • Sydney, New South Wales, Australia, 2217
      • St George Hospital; Medical Oncology
  • Queensland
    • Redcliffe, Queensland, Australia, 4020
      • Redcliffe Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Health Services
    • Frankston, Victoria, Australia, 3199
      • Peninsula and South Eastern Haematology and Oncology Group
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
• Austria
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
• Belgium
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Herstal, Belgium, 4040
    • Clinique André Renard; Pneumologie
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Rumbeke), Apotheek
• Bulgaria
  • Sofia, Bulgaria, 1303
    • Multiprofile Hospital for Active Treatment Serdika EOOD
• Chile
  • Santiago, Chile, 7500006
    • Health & Care SPA
  • Temuco, Chile, 4800827
    • Sociedad de Investigaciones Medicas Ltda (SIM)
  • Viña del Mar, Chile, 2520612
    • Hospital Clinico Vina del Mar?
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing Shi, China, 100050
    • Beijing Friendship Hospital Affiliated of Capital University of Medical Science
  • Changsha CITY, China, 410013
    • Hunan Cancer Hospital
  • Changzhou, China, 213003
    • Changzhou First People's Hospital
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou City, China, 310003
    • The First Affiliated Hospital of Medical School of Zhejiang University
  • Hangzhou City, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University
  • Hefei, China, 230001
    • Anhui Provincial Hospital; 2F,Tumor chemotherapy Department
  • Hefei, China, 230088
    • Anhui Provincial Hospital; Respiratory Department
  • Jinan City, China, 250012
    • Qilu hospital
  • Nanjing City, China, 210029
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Shanghai, China, 200000
    • Shanghai Chest Hospital
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shenyang, China, 110001
    • First Hospital of China Medical University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 3000060
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China, 430023
    • Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan City, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
• France
  • Avignon, France, 84082
    • Institut Sainte Catherine
  • Bron, France, 69677
    • Hopital Louis Pradel; Pneumologie
  • Clermont-ferrand, France, 63003
    • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
  • Creteil, France, 94010
    • Centre Hospitalier Intercommunal; Service de Pneumologie
  • Limoges, France, 87039
    • Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
  • Marseille, France, 13015
    • Hopital Nord AP-HM
  • Montpellier, France, 34298
    • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
  • Mulhouse, France, 68070
    • Centre Hospitalier de Mulhouse - Hopital Emile Muller
  • Saint-Mande, France, 94160
    • Hopital d'Instruction des Armees de Begin
  • Toulon, France, 83041
    • Hopital d Instruction des Armees de Sainte Anne
• Hungary
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Tudogyogyintezet
  • Gyor, Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház
  • Szombathely, Hungary, 9700
    • Markusovszky Hospital
  • Székesfehérvár, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• Ireland
  • Dublin, Ireland, 8
    • St James's Hospital
  • Dublin, Ireland, 7
    • Mater Misecordiae University Hospital
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center
  • Petach Tiqwa, Israel, 4941492
    • Rabin Medical Center
• Italy
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43126
      • Azienda Ospedaliero Universitaria di Parma
    • Ravenna, Emilia-Romagna, Italy, 48100
      • Ospedale Santa Maria delle Croci
  • Lazio
    • Roma, Lazio, Italy, 00144
      • Istituto Nazionale Tumori Regina Elena
    • Roma, Lazio, Italy, 00161
      • Azienda Policlinico Umberto I
  • Piemonte
    • Orbassano (TO), Piemonte, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
  • Puglia
    • Lecce, Puglia, Italy, 73044
      • Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica
    • San Giovanni Rotondo, Puglia, Italy, 71013
      • Ospedale Casa Sollievo Della Sofferenza IRCCS
  • Sicilia
    • Taormina, Sicilia, Italy, 98039
      • Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica
  • Toscana
    • Lucca, Toscana, Italy, 55100
      • Ospedale San Luca - USL2 Lucca
• Japan
  • Aichi, Japan, 460-0001
    • National Hospital Organization Nagoya Medical Center
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido, Japan, 070-8644
    • National Hospital Organization Asahikawa Medical Center
  • Hyogo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Ishikawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa cancer center
  • Miyagi, Japan, 980-8574
    • Tohoku University Hospital
  • Niigata, Japan, 951-8520
    • Niigata University Medical & Dental Hospital
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Osaka, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 141-8625
    • NTT Medical Center Tokyo
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • Tokyo, Japan, 113-8603
    • Nippon Medical School Hospital
  • Yamaguchi, Japan, 755-0241
    • National Hospital Organization Yamaguchi - Ube Medical Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Latvia
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital Latvian Oncology Centre
• Lithuania
  • Panevezys, Lithuania, 35144
    • Panevezys Hospital
• Malaysia
  • FED. Territory OF Kuala Lumpur
    • Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur
  • Penang
    • Kepala Batas, Penang, Malaysia, 13200
      • Advanced Medical and Dental Institute; Kompleks Klinikal
• Netherlands
  • Breda, Netherlands, 4819 EV
    • Amphia Ziekenhuis
  • Den Haag, Netherlands, 2547 EX
    • Haga ziekenhuis
  • EDE, Netherlands, 6716 RP
    • Ziekenhuis Gelderse Vallei
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St. Jansdal
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard Geleen
  • Tilburg, Netherlands, 5042AD
    • ETZ TweeSteden
• Peru
  • Lima, Peru, 31
    • Hospital Nacional Cayetano Heredia
• Portugal
  • Loures, Portugal, 2674-514
    • Hospital Beatriz Angelo
  • Matosinhos, Portugal, 4454-509
    • Unidade Local de Saúde de Matosinhos SA
  • Senhora Da Hora - Porto, Portugal, 4460-188
    • Hospital CUF Porto; Servico de Imunoalergologia
• Romania
  • Cluj-Napoca, Romania, 400058
    • Medisprof srl
  • Constanta, Romania, 900591
    • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
  • Iasi, Romania, 700106
    • Euroclinic Center of Oncology SRL
• Russian Federation
  • Yaroslavl, Russian Federation, 150040
    • Regional Clinical Oncology Hospital
  • Moskovskaja Oblast
    • Chelyabinsk, Moskovskaja Oblast, Russian Federation, 454087
      • Chelyabinsk Regional Clinical Oncology Dispensary
    • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
      • Moscow City Oncology Hospital #62
• Spain
  • Alicante, Spain, 03010
    • Hospital General Univ. de Alicante
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu I Sant Pau
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
  • Burgos, Spain, 09006
    • C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Madrid, Spain, 28050
    • HM Sanchinarro ? CIOCC
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Oncologia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • ICO L'Hospitalet; Servicio de oncologia medica
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Sant Andreu de La Barca, Barcelona, Spain, 08740
      • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Cantabria
    • Mataro, Cantabria, Spain, 08304
      • Hospital de Mataró
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain, 20014
      • Onkologikoa; Ensayos Clinicos
  • LA Coruña
    • A Coruna, LA Coruña, Spain, 15009
      • Centro Oncologico de Galicia COG; Medical Oncology
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oncologia
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra; Servicio de Oncologia
  • Sevilla
    • Seville, Sevilla, Spain, 41014
      • Complejo Hospitalario Nuestra Senora de Valme
• Taiwan
  • Dalin, Chiayi, Taiwan, 622
    • Buddhist Dalin Tzuchi General Hospital
  • Kaohsiung, Taiwan, 824
    • E-DA Hospital; Chest
  • Liuying Township, Taiwan, 736
    • Chi Mei Medical Center Liou Ying Campus
  • Taipei, Taiwan, 11490
    • Tri-service general hospital
  • Taipei, Taiwan, 100
    • National Taiwan Uni Hospital; Internal Medicine
  • Taipei City, Taiwan, 112
    • Taipei Veterans General Hospital
• Ukraine
  • Cherkasy, Ukraine, 18009
    • MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology
  • Kirovograd, Ukraine, 25006
    • Private Enterprise Private Manufacturing Company Acinus
  • Sumy, Ukraine, 40022
    • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department
  • Zaporizhzhya, Ukraine, 69040
    • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
  • Katerynoslav Governorate
    • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
      • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
  • Kharkiv Governorate
    • Kyiv, Kharkiv Governorate, Ukraine, 02096
      • Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Gartnavel General Hospital; Beatson West of Scotland Cancer Centre
  • Inverness, United Kingdom, IV2 3UV
    • Raigmore Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SW17 ORE
    • St George?s Hospital
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital; Plymouth Oncology Centre
  • Romford, United Kingdom, RM7 0AG
    • Queen's Hospital
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital
• United States
  • California
    • Los Angeles, California, United States, 90017
      • Los Angeles Hematology Oncology Medical Group
    • Sebastopol, California, United States, 95472
      • St. Joseph Heritage Healthcare
  • Connecticut
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital; BCC, MOHR
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Inc.
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Tinley Park, Illinois, United States, 60487
      • HealthCare Research Network II, LLC - PPDS
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Med Oncology & Hematology Inc
    • Goshen, Indiana, United States, 46526
      • Goshen Health System
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky; Markey Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0934
      • University of Michigan
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • CHI Health St. Francis
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Cary, North Carolina, United States, 27513
      • Swedish Cancer Institute
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Oncology Consultants PA
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists (Fairfax) - USOR
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute
    • Roanoke, Virginia, United States, 24014
      • Blue Ridge Cancer Care
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • St. Vincent Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed; Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.	Drug: Atezolizumab; Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.; Other Names: MPDL3280A; TECENTRIQ; Drug: Carboplatin; Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.; Drug: Cisplatin; Participants received IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.; Drug: Pemetrexed; Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Active Comparator: Arm B (Carboplatin or Cisplatin + Pemetrexed); Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.	Drug: Carboplatin; Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.; Drug: Cisplatin; Participants received IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.; Drug: Pemetrexed; Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.	Randomization up to approximately 39 months
Overall Survival (OS)	OS is defined as time from randomization to death from any cause.	Randomization up to approximately 39 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate at Year 1	The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization.	Year 1
Overall Survival Rate Year 2	The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.	Year 2
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1	An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response.	Randomization up to approximately 25 months
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1	DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.	Randomization up to approximately 25 months
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score	EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).	Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score	The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).	Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score	Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.	Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Minimum Observed Serum Atezolizumab Concentration (Cmin)	Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)	Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months)
Maximum Observed Serum Atezolizumab Concentration (Cmax)	Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)	Day 1 of Cycle 1 (Cycle length=21 days)
Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)		Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)		Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)		Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab	Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)	Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.
• Lu S, Fang J, Wang Z, Fan Y, Liu Y, He J, Zhou J, Hu J, Xia J, Liu W, Shi J, Yi J, Cao L. Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer. Cancer Med. 2023 Feb;12(3):2666-2676. doi: 10.1002/cam4.5144. Epub 2022 Sep 2.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2016
• Primary Completion (Actual): July 18, 2019
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimated): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Carboplatin; Pemetrexed; Atezolizumab
• Other Study ID Numbers: GO29438; 2015-003605-42 (EudraCT Number)