A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT02367781
Last Updated: 2021-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
723 participants
INTERVENTIONAL
2015-04-16
2021-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurred first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Carboplatin
Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Nab-Paclitaxel
Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m\^2) on Days 1, 8, and 15 of each 21-day cycle.
Arm B (Nab-Paclitaxel+Carboplatin)
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurred first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Carboplatin
Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Nab-Paclitaxel
Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m\^2) on Days 1, 8, and 15 of each 21-day cycle.
Pemetrexed
Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.
Interventions
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Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Carboplatin
Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Nab-Paclitaxel
Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m\^2) on Days 1, 8, and 15 of each 21-day cycle.
Pemetrexed
Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
* Participants with no prior treatment for Stage IV non-squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from fresh 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 metastases
* 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
General Medical Exclusions:
* 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 scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Severe infection within 4 weeks prior to randomization
* Significant cardiovascular disease
* Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures
* Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
Kaiser Permanente - Sacramento Medical Center and Medical Offices
Sacramento, California, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, United States
Kaiser Permanente - San Jose Medical Center
San Jose, California, United States
Kaiser Permanente - San Leandro Medical Center
San Leandro, California, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, United States
Kaiser Permanente - South San Francisco
South San Francisco, California, United States
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich, Connecticut, United States
University of Miami School of Medicine - Sylvester at Deerfield
Deerfield Beach, Florida, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Florida Hospital
Orlando, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, United States
SCRI Florida Cancer Specialists East
West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton, Georgia, United States
Suburban Hematology / Oncology Associates
Lawrenceville, Georgia, United States
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Quincy Medical Group
Quincy, Illinois, United States
Southern Illinois University, Simmons Cancer Institute
Springfield, Illinois, United States
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Lahey Clinic Med Ctr
Lexington, Kentucky, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States
Southcoast Health System
Fairhaven, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Hematology and Oncology Associates at Bridgepoint
Tupelo, Mississippi, United States
Southeast Nebraska Cancer Ctr
Lincoln, Nebraska, United States
Va Sierra Nevada Health Care System
Reno, Nevada, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Cancer Inst. of New Jersey
New Brunswick, New Jersey, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
Clinical Research Alliance
Westbury, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Duke University Medical Center; Department of Medicine
Durham, North Carolina, United States
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Mark H. Zangmeister Center
Columbus, Ohio, United States
Oncology Hematology Care, Inc.
Hamilton, Ohio, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Greenville Health System; Cancer Center
Greenville, South Carolina, United States
University Oncology Associates
Chattanooga, Tennessee, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
SCRI The Center For Cancer and Blood Disorders
Denton, Texas, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Cancer Care Network of South Texas - SAT & BC
San Antonio, Texas, United States
Cliniques Universitaires St-Luc
Brussels, , Belgium
CHU Ambroise Paré
Mons, , Belgium
Werken Glorieux VZW
Ronse, , Belgium
GasthuisZusters Antwerpen
Wilrijk, , Belgium
BC Cancer - Surrey
Surrey, British Columbia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
William Osler Health Centre
Etobicoke, Ontario, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Institut Hospitalier Franco-Britannique; Cancerologie
Levallois-Perret, , France
Fondation Hopital Saint Joseph;Cardiologie Clinique
Marseille, , France
Clinique Clementville; Hopital De Jour
Montpellier, , France
Centre D'oncologie de Gentilly; Service Oncologie Medicale
Nancy, , France
Clinique Catherine de Sienne
Nantes, , France
Hopital American de Paris (American Hospital of Paris)
Neuilly-sur-Seine, , France
HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
Orléans, , France
Hopital Pontchaillou
Rennes, , France
Hopital d'Instruction des Armees de Begin
Saint-Mandé, , France
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
Saint-Pierre, , France
CHRU Nancy; Pneumologie
Vandœuvre-lès-Nancy, , France
Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Bezirksklinikum Obermain
Ebensfeld, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
St. Antonius Hospital
Eschweiler, , Germany
Klinikum Esslingen GmbH; Frauenklinik
Esslingen am Neckar, , Germany
Malteser Krankenhaus St. Franziskus-Hospital
Flensburg, , Germany
Krankenhaus Nordwest
Frankfurt am Main, , Germany
Asklepios Fachkliniken GmbH
Gauting, , Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera, , Germany
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
Gerlingen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
St. Vincentius Kliniken Karlsruhe
Karlsruhe, , Germany
Klinikum Kassel; Hautklinik
Kassel, , Germany
Katholisches Klinikum Marienhof
Koblenz Am Rhein, , Germany
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
Lübeck, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
LMU Klinikum der Universitat Munchen
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Praxis fur Haematologie und Internistische Onkologie
Velbert, , Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, , Germany
Helios Klinik Wuppertal
Wuppertal, , Germany
Assaf Harofeh Medical Center
Beer Yaakov, , Israel
Soroka University Medical Centre
Beersheba, , Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, , Israel
Meir Medical Center; Oncology
Kfar Saba, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center
Petach Tiqwa, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Rambam Health Corporation; Oncology Institute
Rambam, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, , Israel
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino, Campania, Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
Napoli, Campania, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, Italy
Ospedale Di Macerata; Oncologia
Macerata, The Marches, Italy
Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera
Perugia, Umbria, Italy
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon de LA Plana/castello de LA Plana, Castellon, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruña, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, Spain
Hospital Universitario de Canarias
S. Cristobal de La Laguna, Tenerife, Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital de San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital General Universitario de Guadalajara
Guadalajara, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital NisA 9 de Octubre
Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, , Spain
Countries
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References
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Socinski MA, Jotte RM, Cappuzzo F, Nishio M, Mok TSK, Reck M, Finley GG, Kaul MD, Yu W, Paranthaman N, Bara I, West HJ. Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials. JAMA Oncol. 2023 Apr 1;9(4):527-535. doi: 10.1001/jamaoncol.2022.7711.
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.
West H, McCleod M, Hussein M, Morabito A, Rittmeyer A, Conter HJ, Kopp HG, Daniel D, McCune S, Mekhail T, Zer A, Reinmuth N, Sadiq A, Sandler A, Lin W, Ochi Lohmann T, Archer V, Wang L, Kowanetz M, Cappuzzo F. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-003206-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29537
Identifier Type: -
Identifier Source: org_study_id
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