A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Squamous Non-Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
Exclusion Criteria:
- Active or untreated central nervous system (CNS) metastasis
- 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 Computed Tomography (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 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
Sites / Locations
- Ironwood Cancer & Research Centers
- Highlands Oncology Group
- Southern CA Permanente Med Grp
- Kaiser Permanente Oakland Medical Center
- Kaiser Permanente - Sacramento Medical Center and Medical Offices
- Kaiser Permanente - San Leandro Medical Center
- Kaiser Permanente - Santa Clara
- Kaiser Permanente; Oncology Clinical Trials
- Kaiser Permanente - Walnut Creek
- Rocky Mountain Cancer Center
- Danbury Hospital
- Holy Cross Hospital Inc
- SCRI Florida Cancer Specialists South
- Florida Cancer Specialists
- Hematology Oncology Associates of the Treasure Coast
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
- University Cancer & Blood Center, LLC; Research
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
- Central Georgia Cancer Care PC
- Southeastern Regional Medical Center, Inc.
- University of Chicago
- Joliet Oncology-Hematology; Associates, Ltd.
- Quincy Medical Group
- Fort Wayne Med Oncology & Hematology Inc
- Hematology-Oncology; Associates of the Quad Cities
- Siouxland Hematology/Oncology
- Lahey Clinic Med Ctr
- Norton Cancer Institute
- Ochsner Clinic Foundation
- New England Cancer Specialists
- Southcoast Health System; Southcoast Centers For Cancer Care
- St. Joseph Mercy Health System
- Karmanos Cancer Institute
- St. Luke's Regional Cancer Center
- Hematology and Oncology Associates at Bridgepoint
- Billings Clinic
- Valley Hospital; Oncology Research
- Regional Cancer Care Associates LLC
- Clinical Research Alliance
- W.G. Bill Hefner VA Medical Center
- University of Cincinnati
- Mark H. Zangmeister Center
- Oncology Hematology Care, Inc.
- Oregon Health & Science Uni
- St. Luke's Cancer Care Associates
- Maryland Oncology Hematology (Lanham) - USOR
- Allegheny Cancer Center
- Univ of Pittsburgh Medical Ctr
- SCRI Tennessee Oncology Chattanooga
- Tennessee Cancer Specialists
- SCRI The Center For Cancer and Blood Disorders
- Longview Cancer Center
- Virginia Cancer Specialists, PC
- Virginia Oncology Associates
- Blue Ridge Cancer Care
- Providence Regional Cancer Partnership
- Medical Oncology Associates
- Fundación CENIT para la Investigación en Neurociencias
- Sanatorio Allende
- Centro Oncologico Riojano Integral (CORI)
- Clínica Pergamino
- Fundacion Koriza
- Centro de Investigacion; Clinica - Clinica Viedma S.A.
- Chris O'Brien Lifehouse
- Calvary Mater Newcastle; Medical Oncology
- Prince Charles Hospital
- Townsville Hospital
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Austin Health
- Cabrini Hospital Malvern
- Sunshine Hospital
- Sir Charles Gairdner Hospital
- Paracelsus Medizinische Privatuniversität
- Cliniques Universitaires St-Luc
- CHU Sart-Tilman
- Clinique Ste-Elisabeth
- Werken Glorieux VZW
- GasthuisZusters Antwerpen
- Cenantron - Centro Avancado de Tratamento Oncologico
- Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica
- Liga Norte Riograndense Contra O Câncer
- IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
- Hospital Bruno Born
- Hospital das Clinicas - UFRGS
- Hospital Mae de Deus
- *X*Fundação Pio XII Hospital de Câncer de Barretos
- Hospital de Base de Sao Jose do Rio Preto
- Hospital Do Cancer A C Camargo
- Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
- Multiprofile Hospital for Active Treatment Serdika EOOD
- Royal Victoria Regional Health Centre
- William Osler Health Centre
- Lakeridge Health Center
- Cite de La Sante de Laval; Hemato-Oncologie
- Hôpital du Sacré-Coeur de Montreal
- St. Jerome Medical Research
- Health & Care SPA
- Sociedad de Investigaciones Medicas Ltda (SIM)
- CHU de Grenoble
- Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
- Clinique Clémentville
- Hopital de La Source
- Centre Hospitalier Lyon Sud
- Hopital de Pontchaillou; Service de Pneumologie
- Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
- CH de Saint Quentin
- Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques
- Charite - Universitätsmedizin Berlin
- Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
- Augusta Kranken-Anstalt gGmbH
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
- St. Elisabethen Krankenhaus
- Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
- LungenClinic Großhansdorf GmbH
- Krankenhaus Martha-Maria; Halle-Dolau gGmbH
- Universitätsklinikum Hamburg-Eppendorf
- Asklepios Klinik Harburg
- Lungenklinik Hemer
- Universität Des Saarlandes; Klinik für Innere Medizin V
- Fachklinik für Lungenerkrankungen
- Kliniken der Stadt Koln gGmbH
- Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
- Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
- Krankenhaus Barmherzige Bruder Regensburg
- Klinikum der Universität Regensburg
- Stiftung Mathias-Spital Rheine
- Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
- Soroka Medical Center
- Hadassah University Hospital - Ein Kerem
- Meir Medical Center; Oncology
- Rabin Medical Center
- Chaim Sheba Medical Center; Oncology Dept
- Rambam Health Corporation; Oncology Institute
- Tel Aviv Sourasky Medical Ctr; Oncology
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
- AORN A Cardarelli
- Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
- Azienda Ospedaliera San Camillo Forlanini
- ASL 3 Genovese; DSM
- Fondazione IRCCS Policlinico San Matteo
- IRCCS Giovanni Paolo II Istituto Oncologico
- Policlinico Vittorio Emanuele
- Ospedale Civile - Livorno
- Azienda Ospedaliero Universitaria Pisana
- Ospedale Silvestrini
- Aichi Cancer Center Hospital; Respiratory Medicine
- Nagoya University Hospital; Respiratory Medicine
- National Cancer Center Hospital East; Thoracic Oncology
- National Hospital Organization Shikoku Cancer Center; Internal Medicine
- National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
- Kyushu University Hospital; Respiratory
- Kobe City Medical Center General Hospital; Respiratory Medicine
- National Hospital Organization Himeji Medical Center
- Hyogo Cancer Center; Thoracic Oncology
- Ibaraki Prefectural Central Hospital; Division of respiratory
- Kanagawa Cancer Center;Thoracic Oncology
- Kyoto University Hospital, Respiratory Medicine
- Sendai Kousei Hospital; Pulmonary Medicine
- Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease
- Okayama University Hospital; Respiratory and Allergy Medicine
- Osaka International Cancer Institute; Thoracic Oncology
- Osaka City Uni Hospital; Respiratory Medicine
- Kansai Medical university Hospital; Thoracic Oncology
- Osaka Habikino Medical Center
- National Hospital Organization Kinki-Chuo Chest Medical Center
- Saitama Cancer Center; Thoracic Oncology
- Shizuoka Cancer Center; Thoracic Oncology
- National Cancer Center Hospital; Thoracic Medical Oncology
- Tokyo Medical University Hospital; Dept of Surgery
- Riga East Clinical University Hospital Latvian Oncology Centre
- Pauls Stradins Clinical University Hospital
- National Cancer Institute
- Centro Universitario Contra El Cancer
- Cancerología
- VU Medisch Centrum; VU University Medical Center
- Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
- Ziekenhuis Gelderse Vallei
- Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose
- St. Antonius Ziekenhuis; R&D Long
- Centro Medico Monte Carmelo
- Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
- Instituto Regional de Enfermedades Neoplásicas Del Norte
- IPO de Lisboa; Servico de Pneumologia
- Hospital Pulido Valente; Servico de Pneumologia
- Centro Hospitalar do Porto - Hospital de Santo António
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
- Hospital de Sao Joao; Servico de Pneumologia
- Moscow City Oncology Hospital #62
- Russian Oncology Research Center n.a. N.N. Blokhin
- Clinical Oncology Dispensary
- City Clinical Oncology Dispensary
- Volgograd Regional Clinical Oncology Dispensary
- National University Hospital
- National Cancer Centre
- Univerzitna nemocnica Bratislava
- Narodny onkologicky ustav
- POKO Poprad s.r.o.
- Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
- Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
- Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
- Hospital Universitario Son Espases
- Complejo Hospitalario Universitario A Coruña
- Complejo Hospitalario Universitario Insular-Materno Infantil
- Hospital Nuestra Senora de Valme
- Hospital Universitario de Canarias
- Hospital del Mar
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital Clinic de Barcelona
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
- Hospital Universitario Reina Sofia
- Hospital Lucus Augusti; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Hospital Universitario La Paz
- Hospital Ramon y Cajal; Servicio de Oncologia
- Fundación Jimenez Díaz
- Hospital Clinico San Carlos; Servicio de Oncologia
- Hospital Universitario 12 de Octubre
- HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
- Hospital Clinico Universitario de Valencia
- Hospital General Universitario de Valencia
- Hospital Universitario Miguel Servet
- Changhua Christian Hospital; Hematology-Oncology
- Kaohsiung Medical University Hospital; Department of Urology
- Chi Mei Medical Center Liou Ying Campus
- Chang Gung Memorial Hospital Chiayi
- China Medical University Hospital
- National Taiwan Uni Hospital
- Mackay Memorial Hospital
- Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy
- Uzhgorod Central City Clinical Hospital
- MNPE Zaporizhzhia Regional Antitumor Center ZRC
- Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
- Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
- MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy
- Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1
- SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
- ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
- Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Arm A: Atezolizumab + Paclitaxel + Carboplatin
Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin
Arm C: Nab-Paclitaxel + Carboplatin
The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.