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]

• ClinicalTrials.gov Identifier: NCT02367794
• Recruitment Status: Completed
• First Posted: February 20, 2015
• Results First Posted: November 12, 2019
• Last Update Posted: April 13, 2021
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

Condition or disease	Intervention/treatment	Phase
Squamous Non-Small Cell Lung Cancer	Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel; Drug: Paclitaxel	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1021 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
• Actual Study Start Date: June 11, 2015
• Actual Primary Completion Date: October 3, 2018
• Actual Study Completion Date: February 17, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A: Atezolizumab + 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.	Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.; Other Name: Tecentriq; Drug: Carboplatin; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Drug: Paclitaxel; Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.
Experimental: Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin; 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.	Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody; Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.; Other Name: Tecentriq; Drug: Carboplatin; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Drug: Nab-Paclitaxel; Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Active Comparator: Arm C: Nab-Paclitaxel + Carboplatin; 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.	Drug: Carboplatin; Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.; Drug: Nab-Paclitaxel; Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
   PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.
2. Overall Survival (OS) in the ITT Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
   OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.

Secondary Outcome Measures :

1. OS in the Tumor Gene Expression (tGE) Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
2. PFS as Determined by the Investigator Using RECIST v1.1 in the tGE Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
3. PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
4. PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
5. OS in the TC2/3 or IC2/3 Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
6. OS in the TC1/2/3 or IC1/2/3 Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
7. Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
8. Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
9. OS at 1 and 2 Years in the ITT Population [ Time Frame: 1 and 2 years ]
   OS rates at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population
10. Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
11. TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population [ Time Frame: Up to approximately 30 months after the first participant enrolled ]
12. Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population [ Time Frame: Baseline up to approximately 30 months after first participant enrolled ]
13. PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs. Arm B) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
14. OS in the ITT Population (Arm A vs. Arm B) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
15. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 39 months after first participant enrolled ]
16. Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration.
17. Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle up to 39 months; 30 minutes postdose on Day 1 of Cycles 1 and 3; at treatment discontinuation (up to 39 months), and at 120 days after last dose of atezolizumab (up to 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
18. Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration.
19. Plasma Concentrations for Paclitaxel [ Time Frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) ]
20. Plasma Concentrations for Nab-Paclitaxel [ Time Frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) ]
21. Plasma Concentrations for Carboplatin [ Time Frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Arizona

Ironwood Cancer & Research Centers

Chandler, Arizona, United States, 85224

United States, Arkansas

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

United States, California

Southern CA Permanente Med Grp

Bellflower, California, United States

Kaiser Permanente Oakland Medical Center

Oakland, California, United States, 94611

Kaiser Permanente - Sacramento Medical Center and Medical Offices

Sacramento, California, United States, 95825

Kaiser Permanente - San Leandro Medical Center

San Leandro, California, United States, 94577

Kaiser Permanente - Santa Clara

Santa Clara, California, United States, 95051

Kaiser Permanente; Oncology Clinical Trials

Vallejo, California, United States, 94589

Kaiser Permanente - Walnut Creek

Walnut Creek, California, United States, 94596

United States, Colorado

Rocky Mountain Cancer Center

Denver, Colorado, United States, 80218

United States, Connecticut

Danbury Hospital

Danbury, Connecticut, United States, 06810

United States, Florida

Holy Cross Hospital Inc

Fort Lauderdale, Florida, United States, 33308

SCRI Florida Cancer Specialists South

Fort Myers, Florida, United States, 33916

Florida Cancer Specialists

Palm Beach Gardens, Florida, United States, 33410

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States, 34952

Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

Saint Petersburg, Florida, United States, 33705

United States, Georgia

University Cancer & Blood Center, LLC; Research

Athens, Georgia, United States, 30607

Northwest Georgia Oncology Centers P.C.

Carrollton, Georgia, United States, 30117

Central Georgia Cancer Care PC

Macon, Georgia, United States, 31201

Southeastern Regional Medical Center, Inc.

Newnan, Georgia, United States, 30265

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Joliet Oncology-Hematology; Associates, Ltd.

Joliet, Illinois, United States, 60435

Quincy Medical Group

Quincy, Illinois, United States, 62301

United States, Indiana

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, United States, 46845

United States, Iowa

Hematology-Oncology; Associates of the Quad Cities

Bettendorf, Iowa, United States, 52722

Siouxland Hematology/Oncology

Sioux City, Iowa, United States, 51101

United States, Kentucky

Lahey Clinic Med Ctr

Lexington, Kentucky, United States, 02421

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Maine

New England Cancer Specialists

Scarborough, Maine, United States, 04074

United States, Massachusetts

Southcoast Health System; Southcoast Centers For Cancer Care

Fairhaven, Massachusetts, United States, 02719

United States, Michigan

St. Joseph Mercy Health System

Ann Arbor, Michigan, United States, 48106

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

United States, Minnesota

St. Luke's Regional Cancer Center

Duluth, Minnesota, United States, 55805

United States, Mississippi

Hematology and Oncology Associates at Bridgepoint

Tupelo, Mississippi, United States, 38801

United States, Montana

Billings Clinic

Billings, Montana, United States, 59102

United States, New Jersey

Valley Hospital; Oncology Research

Paramus, New Jersey, United States, 07652

Regional Cancer Care Associates LLC

Sewell, New Jersey, United States, 08080

United States, New York

Clinical Research Alliance

New Hyde Park, New York, United States, 11042-1083

United States, North Carolina

W.G. Bill Hefner VA Medical Center

Salisbury, North Carolina, United States

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45203-0542

Mark H. Zangmeister Center

Columbus, Ohio, United States, 43219

Oncology Hematology Care, Inc.

Hamilton, Ohio, United States, 45103

United States, Oregon

Oregon Health & Science Uni

Portland, Oregon, United States, 97239

United States, Pennsylvania

St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, United States, 18015

Maryland Oncology Hematology (Lanham) - USOR

Gettysburg, Pennsylvania, United States, 17325

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States, 15212

Univ of Pittsburgh Medical Ctr

Pittsburgh, Pennsylvania, United States, 15232

United States, Tennessee

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States, 37404

Tennessee Cancer Specialists

Knoxville, Tennessee, United States, 37920

United States, Texas

SCRI The Center For Cancer and Blood Disorders

Denton, Texas, United States, 76210

Longview Cancer Center

Longview, Texas, United States, 75601

United States, Virginia

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Blue Ridge Cancer Care

Roanoke, Virginia, United States, 24014

United States, Washington

Providence Regional Cancer Partnership

Everett, Washington, United States, 98201

Medical Oncology Associates

Spokane, Washington, United States, 99208

Argentina

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina, C1125ABD

Sanatorio Allende

Cordoba, Argentina, X5000JHQ

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina, F5300COE

Clínica Pergamino

Pergamino, Argentina, 2700

Fundacion Koriza

Santa Rosa, Argentina, 6300

Centro de Investigacion; Clinica - Clinica Viedma S.A.

Viedma, Argentina, R8500ACE

Australia, New South Wales

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia, 2050

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia, 2298

Australia, Queensland

Prince Charles Hospital

Chermside, Queensland, Australia, 4032

Townsville Hospital

Townsville, Queensland, Australia, 4810

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Austin Health

Heidelberg, Victoria, Australia, 3084

Cabrini Hospital Malvern

Malvern, Victoria, Australia, 3144

Sunshine Hospital

St Albans, Victoria, Australia, 3021

Australia, Western Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Austria

Paracelsus Medizinische Privatuniversität

Salzburg, Austria, 5020

Belgium

Cliniques Universitaires St-Luc

Bruxelles, Belgium, 1200

CHU Sart-Tilman

Liège, Belgium, 4000

Clinique Ste-Elisabeth

Namur, Belgium, 5000

Werken Glorieux VZW

Ronse, Belgium, 9600

GasthuisZusters Antwerpen

Wilrijk, Belgium, 2610

Brazil

Cenantron - Centro Avancado de Tratamento Oncologico

Belo Horizonte, MG, Brazil, 30130-090

Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

Londrina, PR, Brazil, 86 015 520

Liga Norte Riograndense Contra O Câncer

Natal, RN, Brazil, 59040150

IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

Caxias do Sul, RS, Brazil, 95070-560

Hospital Bruno Born

Lajeado, RS, Brazil, 95900-000

Hospital das Clinicas - UFRGS

Porto Alegre, RS, Brazil, 90035-903

Hospital Mae de Deus

Porto Alegre, RS, Brazil, 90470-340

*X*Fundação Pio XII Hospital de Câncer de Barretos

Barretos, SP, Brazil, 14784-400

Hospital de Base de Sao Jose do Rio Preto

Sao Jose do Rio Preto, SP, Brazil, 15090-000

Hospital Do Cancer A C Camargo

Sao Paulo, SP, Brazil, 01525-001

Bulgaria

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, Bulgaria, 4000

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, Bulgaria, 1303

Canada, Ontario

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

William Osler Health Centre

Etobicoke, Ontario, Canada, M9V 1R8

Lakeridge Health Center

Oshawa, Ontario, Canada, L1J 2J2

Canada, Quebec

Cite de La Sante de Laval; Hemato-Oncologie

Laval, Quebec, Canada, H7M 3L9

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada, H4J 1C5

St. Jerome Medical Research

St. Jerome, Quebec, Canada, J7Z 5T3

Chile

Health & Care SPA

Santiago, Chile, 7500006

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, Chile, 4810469

France

CHU de Grenoble

Grenoble, France, 38043

Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

Le Mans, France, 72000

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

Lyon, France, 69008

Clinique Clémentville

Montpellier, France, 34070

Hopital de La Source

Orleans, France, 45067

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

Hopital de Pontchaillou; Service de Pneumologie

Rennes, France, 35033

Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

Saint Pierre, France, 97448

CH de Saint Quentin

Saint Quentin, France, 2100

Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques

Toulon Cedex 9, France, 83800

Germany

Charite - Universitätsmedizin Berlin

Berlin, Germany, 12203

Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

Bielefeld, Germany, 33611

Augusta Kranken-Anstalt gGmbH

Bochum, Germany, 44791

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, Germany, 01307

St. Elisabethen Krankenhaus

Frankfurt am Main, Germany, 60487

Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

Gerlingen, Germany, 70839

LungenClinic Großhansdorf GmbH

Großhansdorf, Germany, 22927

Krankenhaus Martha-Maria; Halle-Dolau gGmbH

Halle, Germany, 06120

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246

Asklepios Klinik Harburg

Hamburg, Germany, 21075

Lungenklinik Hemer

Hemer, Germany, 58675

Universität Des Saarlandes; Klinik für Innere Medizin V

Homburg, Germany, 66421

Fachklinik für Lungenerkrankungen

Immenhausen, Germany, 34376

Kliniken der Stadt Koln gGmbH

Koln, Germany, 51109

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

München, Germany, 81925

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, Germany, 93049

Klinikum der Universität Regensburg

Regensburg, Germany, 93053

Stiftung Mathias-Spital Rheine

Rheine, Germany, 48431

Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

Villingen-Schwenningen, Germany, 78052

Israel

Soroka Medical Center

Beer Sheva, Israel, 8410101

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel, 9112001

Meir Medical Center; Oncology

Kfar-Saba, Israel, 4428164

Rabin Medical Center

Petach Tiqwa, Israel, 49100

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, Israel, 5262100

Rambam Health Corporation; Oncology Institute

Rambam, Israel, 3525408

Tel Aviv Sourasky Medical Ctr; Oncology

Tel Aviv, Israel, 6423906

Italy

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

Avellino, Campania, Italy, 83100

AORN A Cardarelli

Napoli, Campania, Italy, 80131

Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata

Napoli, Campania, Italy, 80131

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

Napoli, Campania, Italy, 80131

Azienda Ospedaliera San Camillo Forlanini

Roma, Lazio, Italy, 00152

ASL 3 Genovese; DSM

Genova, Liguria, Italy, 16147

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardia, Italy, 27100

IRCCS Giovanni Paolo II Istituto Oncologico

Bari, Puglia, Italy, 70124

Policlinico Vittorio Emanuele

Catania, Sicilia, Italy, 95123

Ospedale Civile - Livorno

Livorno, Toscana, Italy, 57124

Azienda Ospedaliero Universitaria Pisana

Pisa, Toscana, Italy, 56100

Ospedale Silvestrini

Perugia, Umbria, Italy, 06122

Japan

Aichi Cancer Center Hospital; Respiratory Medicine

Aichi, Japan, 464-8681

Nagoya University Hospital; Respiratory Medicine

Aichi, Japan, 466-8560

National Cancer Center Hospital East; Thoracic Oncology

Chiba, Japan, 277-8577

National Hospital Organization Shikoku Cancer Center; Internal Medicine

Ehime, Japan, 791-0280

National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

Fukuoka, Japan, 810-8563

Kyushu University Hospital; Respiratory

Fukuoka, Japan, 812-8582

Kobe City Medical Center General Hospital; Respiratory Medicine

Hyogo, Japan, 650-0047

National Hospital Organization Himeji Medical Center

Hyogo, Japan, 670-8520

Hyogo Cancer Center; Thoracic Oncology

Hyogo, Japan, 673-8558

Ibaraki Prefectural Central Hospital; Division of respiratory

Ibaraki, Japan, 309-1793

Kanagawa Cancer Center;Thoracic Oncology

Kanagawa, Japan, 241-8515

Kyoto University Hospital, Respiratory Medicine

Kyoto, Japan, 606-8507

Sendai Kousei Hospital; Pulmonary Medicine

Miyagi, Japan, 980-0873

Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease

Niigata, Japan, 951-8520

Okayama University Hospital; Respiratory and Allergy Medicine

Okayama, Japan, 700-8558

Osaka International Cancer Institute; Thoracic Oncology

Osaka, Japan, 541-8567

Osaka City Uni Hospital; Respiratory Medicine

Osaka, Japan, 545-8586

Kansai Medical university Hospital; Thoracic Oncology

Osaka, Japan, 573-1191

Osaka Habikino Medical Center

Osaka, Japan, 583-8588

Saitama Cancer Center; Thoracic Oncology

Saitama, Japan, 362-0806

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai-shi, Japan, 591-8555

Shizuoka Cancer Center; Thoracic Oncology

Shizuoka, Japan, 411-8777

National Cancer Center Hospital; Thoracic Medical Oncology

Tokyo, Japan, 104-0045

Tokyo Medical University Hospital; Dept of Surgery

Tokyo, Japan, 160-0023

Latvia

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, Latvia, LV-1079

Pauls Stradins Clinical University Hospital

Rīga, Latvia, LV-1002

Lithuania

National Cancer Institute

Vilnius, Lithuania, 08660

Mexico

Centro Universitario Contra El Cancer

Monterrey, Mexico, 64020

Cancerología

Queretaro, Mexico, 76090

Netherlands

VU Medisch Centrum; VU University Medical Center

Amsterdam, Netherlands, 1007 MB

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands, 1066 CX

Ziekenhuis Gelderse Vallei

EDE, Netherlands, 6716 RP

Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose

Eindhoven, Netherlands, 5623 EJ

St. Antonius Ziekenhuis; R&D Long

Nieuwegein, Netherlands, 3435 CM

Peru

Centro Medico Monte Carmelo

Arequipa, Peru, 04001

Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

Lima, Peru, Lima 13

Instituto Regional de Enfermedades Neoplásicas Del Norte

Trujillo, Peru, 12345

Portugal

IPO de Lisboa; Servico de Pneumologia

Lisboa, Portugal, 1099-023

Hospital Pulido Valente; Servico de Pneumologia

Lisboa, Portugal, 1796-001

Centro Hospitalar do Porto - Hospital de Santo António

Porto, Portugal, 4099-001

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

Porto, Portugal, 4200-072

Hospital de Sao Joao; Servico de Pneumologia

Porto, Portugal, 4200

Russian Federation

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423

Russian Oncology Research Center n.a. N.N. Blokhin

Moscow, Russian Federation, 115478

Clinical Oncology Dispensary

Omsk, Russian Federation, 644013

City Clinical Oncology Dispensary

Saint-Petersburg, Russian Federation, 197022

Volgograd Regional Clinical Oncology Dispensary

Volgograd, Russian Federation, 400138

Singapore

National University Hospital

Singapore, Singapore, 119074

National Cancer Centre

Singapore, Singapore, 169610

Slovakia

Univerzitna nemocnica Bratislava

Bratislava, Slovakia, 813 69

Narodny onkologicky ustav

Bratislava, Slovakia, 833 10

POKO Poprad s.r.o.

Poprad, Slovakia, 058 01

Spain

Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

L'Hospitalet de Llobregat, Barcelona, Spain, 08908

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain, 8208

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain, 39008

Hospital Universitario Son Espases

Palma De Mallorca, Islas Baleares, Spain, 07014

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruña, Spain, 15006

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016

Hospital Nuestra Senora de Valme

Seville, Sevilla, Spain, 41014

Hospital Universitario de Canarias

S. Cristobal De La Laguna, Tenerife, Spain, 38320

Hospital del Mar

Barcelona, Spain, 08003

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, Spain, 08041

Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

Hospital Lucus Augusti; Servicio de Oncologia

Lugo, Spain, 27003

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, Spain, 28007

Hospital Universitario La Paz

Madrid, Spain, 280146

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, Spain, 28034

Fundación Jimenez Díaz

Madrid, Spain, 28040

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, Spain, 28040

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, Spain, 28050

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Taiwan

Changhua Christian Hospital; Hematology-Oncology

Changhua, Taiwan, 500

Kaohsiung Medical University Hospital; Department of Urology

Kaohsiung City, Taiwan, 807

Chi Mei Medical Center Liou Ying Campus

Liuying Township, Taiwan, 736

Chang Gung Memorial Hospital Chiayi

Putzu, Taiwan, 613

China Medical University Hospital

Taichung, Taiwan, 40447

National Taiwan Uni Hospital

Taipei City, Taiwan, 10041

Mackay Memorial Hospital

Taipei, Taiwan, 104

Ukraine

Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102

Uzhgorod Central City Clinical Hospital

Uzhhorod, Katerynoslav Governorate, Ukraine, 88000

MNPE Zaporizhzhia Regional Antitumor Center ZRC

Zaporizhzhia, Katerynoslav Governorate, Ukraine, 69040

Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

Kharkiv, Kharkiv Governorate, Ukraine, 61070

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, KIEV Governorate, Ukraine, 21029

MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

Lviv, Volhynian Governorate, Ukraine, 79031

Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1

Chernivtsi, Ukraine, 58013

SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

Kharkiv, Ukraine, 61024

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

Kryvyi Rih, Ukraine, 50048

Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

Poltava, Ukraine, 36011

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, Ukraine, 40005

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] October 24, 2018

Statistical Analysis Plan  [PDF] January 11, 2018

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02367794
• Other Study ID Numbers: GO29437; 2014-003208-59 ( EudraCT Number )
• First Posted: February 20, 2015
• Results First Posted: November 12, 2019
• Last Update Posted: April 13, 2021
• Last Verified: March 2021

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Atezolizumab; Antibodies; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Physiological Effects of Drugs