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) (IMpower130)

• ClinicalTrials.gov Identifier: NCT02367781
• Recruitment Status: Completed
• First Posted: February 20, 2015
• Results First Posted: April 3, 2019
• Last Update Posted: August 9, 2021
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 723 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
• Actual Study Start Date: April 16, 2015
• Actual Primary Completion Date: March 15, 2018
• Actual Study Completion Date: January 18, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Name: MPDL3280A, RO5541267, Tecentriq; Drug: 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.; Drug: 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.
Active Comparator: 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.	Drug: 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.; Other Name: MPDL3280A, RO5541267, Tecentriq; Drug: 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.; Drug: 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.; Drug: Pemetrexed; Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.

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 ITT-WT Population [ Time Frame: Up to approximately 35 months after first patient enrolled ]
   PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.
2. Overall Survival (OS) in the ITT-WT Population [ Time Frame: Up to approximately 35 months after first patient enrolled ]
   OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.

Secondary Outcome Measures :

1. PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population [ Time Frame: Up to approximately 35 months after first subject enrolled ]
   PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
2. OS as Determined by the Investigator Using Recist v1.1 in the ITT Population [ Time Frame: Up to approximately 41 months after first subject enrolled ]
   OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
3. OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population [ Time Frame: Up to approximately 35 months after first patient enrolled ]
   OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
4. Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population [ Time Frame: Up to approximately 41 months after first subject enrolled ]
   ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.
5. Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population [ Time Frame: Up to approximately 35 months after first subject enrolled ]
   ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
6. Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population [ Time Frame: Up to approximately 35 months after first subject enrolled ]
   DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue;PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue;PD-L1 IHC TC3 or IC3 population,defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue.PD-L1 expression WT is defined as PD-L1 expression population excluding participants with activating EGFR mutation or ALK translocation.
7. Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population [ Time Frame: Up to 41 months after first patient enrolled, years 1 and 2 reported ]
   The OS rate at the 1- and 2-year landmark time points after randomization.
8. Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population [ Time Frame: Up to 35 months after first patient enrolled, years 1 and 2 reported ]
   The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
9. Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population [ Time Frame: Up to approximately 35 months after first subject enrolled ]
   Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
10. Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale [ Time Frame: Up to approximately 35 months after first subject enrolled ]
    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.
11. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 69 months after first patient enrolled ]
    Percentage of participants with at least one adverse event. Adverse event onset date before cross over.
12. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Up to approximately 35 months after first subject enrolled ]
    Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants
13. Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm [ Time Frame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days) ]
    Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
14. Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel [ Time Frame: Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days) ]
    Predose samples will be collected on the same day of treatment administration.
15. Plasma Concentrations of Carboplatin [ Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 hour after carboplatin infusion (infusion duration=15 to 30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months) ]
16. Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel [ Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months) ]

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 performance status of 0 or 1
• 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:

Cancer-Specific Exclusions:

• 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

Exclusion Criteria Related to Medications:

• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

Contacts and Locations

Locations

United States, Arkansas

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

United States, California

Kaiser Permanente Oakland Medical Center

Oakland, California, United States, 94611

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States, 95661

Kaiser Permanente - Sacramento Medical Center and Medical Offices

Sacramento, California, United States, 95825

Kaiser Permanente - San Francisco Medical Center

San Francisco, California, United States, 94118

Kaiser Permanente - San Jose Medical Center

San Jose, California, United States, 95119

Kaiser Permanente - San Leandro Medical Center

San Leandro, California, United States, 94577

Kaiser Permanente - Santa Clara

Santa Clara, California, United States, 95051

Kaiser Permanente - South San Francisco

South San Francisco, California, United States, 94080

Kaiser Permanente; Oncology Clinical Trials

Vallejo, California, United States, 94589

Kaiser Permanente - Walnut Creek

Walnut Creek, California, United States, 94596

United States, Colorado

Banner MD Anderson Cancer Center

Greeley, Colorado, United States, 85234

United States, Connecticut

Eastern Connecticut Hematology and Oncology Associates; (ECHO)

Norwich, Connecticut, United States, 06360

United States, Florida

University of Miami School of Medicine - Sylvester at Deerfield

Deerfield Beach, Florida, United States, Suite 200

SCRI Florida Cancer Specialists South

Fort Myers, Florida, United States, 33916

Florida Hospital

Orlando, Florida, United States, 32803

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

Saint Petersburg, Florida, United States, 33705

SCRI Florida Cancer Specialists East

West Palm Beach, Florida, United States, 33401

United States, Georgia

University Cancer & Blood Center, LLC; Research

Athens, Georgia, United States, 30607

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Carrollton, Georgia, United States, 30117

Suburban Hematology / Oncology Associates

Lawrenceville, Georgia, United States, 30046

Southeastern Regional Medical Center, Inc.

Newnan, Georgia, United States, 30265

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Joliet Oncology-Hematology; Associates, Ltd.

Joliet, Illinois, United States, 60435

Illinois Cancer Care

Peoria, Illinois, United States, 61615

Quincy Medical Group

Quincy, Illinois, United States, 62301

Southern Illinois University, Simmons Cancer Institute

Springfield, Illinois, United States, 62794

United States, Indiana

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, United States, 46845

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242-1083

United States, Kentucky

Lahey Clinic Med Ctr

Lexington, Kentucky, United States, 02421

United States, Maryland

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20814

Center For Cancer and Blood Disorders

Bethesda, Maryland, United States, 20817

United States, Massachusetts

Southcoast Health System

Fairhaven, Massachusetts, United States, 02719

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Mississippi

Hematology and Oncology Associates at Bridgepoint

Tupelo, Mississippi, United States, 38801

United States, Nebraska

Southeast Nebraska Cancer Ctr

Lincoln, Nebraska, United States, 68510

United States, Nevada

Va Sierra Nevada Health Care System

Reno, Nevada, United States, 89502

United States, New Jersey

Englewood Hospital and Medical Center

Englewood, New Jersey, United States, 07631

Saint Barnabas Medical Center

Livingston, New Jersey, United States, 07039

Cancer Inst. of New Jersey

New Brunswick, New Jersey, United States, 08901

United States, New York

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, United States, 10016

Clinical Research Alliance

Westbury, New York, United States, 11590

United States, North Carolina

Presbyterian Hospital

Charlotte, North Carolina, United States, 28204

Duke University Medical Center; Department of Medicine

Durham, North Carolina, United States, 27710

W.G. Bill Hefner VA Medical Center

Salisbury, North Carolina, United States

United States, Ohio

The Christ Hospital

Cincinnati, Ohio, United States, 45219

Mark H. Zangmeister Center

Columbus, Ohio, United States, 43219

Oncology Hematology Care, Inc.

Hamilton, Ohio, United States, 45103

United States, Pennsylvania

Pinnacle Health

Harrisburg, Pennsylvania, United States, 17110

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17604

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, South Carolina

Greenville Health System; Cancer Center

Greenville, South Carolina, United States, 29605-4292

United States, Tennessee

University Oncology Associates

Chattanooga, Tennessee, United States, 37403

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States, 37404

United States, Texas

SCRI The Center For Cancer and Blood Disorders

Denton, Texas, United States, 76210

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Cancer Care Network of South Texas - SAT & BC

San Antonio, Texas, United States, 78217

Belgium

Cliniques Universitaires St-Luc

Bruxelles, Belgium, 1200

CHU Ambroise Paré

Mons, Belgium, 7000

Werken Glorieux VZW

Ronse, Belgium, 9600

GasthuisZusters Antwerpen

Wilrijk, Belgium, 2610

Canada, British Columbia

BC Cancer - Surrey

Surrey, British Columbia, Canada, V3V 1Z2

Canada, Ontario

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

William Osler Health Centre

Etobicoke, Ontario, Canada, M9V 1R8

Canada, Quebec

Cite de La Sante de Laval; Hemato-Oncologie

Laval, Quebec, Canada, H7M 3L9

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, Canada, H1T 2M4

France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France, 33300

Institut Hospitalier Franco-Britannique; Cancerologie

Levallois-Perret, France, 92300

Fondation Hopital Saint Joseph;Cardiologie Clinique

Marseille, France, 13285

Clinique Clementville; Hopital De Jour

Montpellier, France, 34070

Centre D'oncologie de Gentilly; Service Oncologie Medicale

Nancy, France, 54100

Clinique Catherine de Sienne

Nantes, France, 44202

Hopital American de Paris (American Hospital of Paris)

Neuilly sur Seine, France, 92200

HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

Orleans, France, 45100

Hopital Pontchaillou

Rennes, France, 35033

Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

Saint Pierre, France, 97448

Hopital d'Instruction des Armees de Begin

Saint-Mande, France, 94160

CHRU Nancy; Pneumologie

Vandoeuvre-lès-nancy, France, 54511

Germany

Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie

Berlin, Germany, 13353

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 09116

Bezirksklinikum Obermain

Ebensfeld, Germany, 96250

Helios Klinikum Erfurt

Erfurt, Germany, 99089

St. Antonius Hospital

Eschweiler, Germany, 52249

Klinikum Esslingen GmbH; Frauenklinik

Esslingen Am Neckar, Germany, 73730

Malteser Krankenhaus St. Franziskus-Hospital

Flensburg, Germany, 24939

Krankenhaus Nordwest

Frankfurt am Main, Germany, 60488

Asklepios Fachkliniken GmbH

Gauting, Germany, 82131

SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

Gera, Germany, 07548

Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

Gerlingen, Germany, 70839

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany, 69126

Fachklinik für Lungenerkrankungen

Immenhausen, Germany, 34376

St. Vincentius Kliniken Karlsruhe

Karlsruhe, Germany, 76137

Klinikum Kassel; Hautklinik

Kassel, Germany, 34125

Katholisches Klinikum Marienhof

Koblenz Am Rhein, Germany, 56073

Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

Lubeck, Germany, 23538

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, Germany, 68167

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

LMU Klinikum der Universitat Munchen

Munchen, Germany, 80337

Universitätsklinikum Tübingen

Tuebingen, Germany, 72076

Praxis fur Haematologie und Internistische Onkologie

Velbert, Germany, 42551

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

Villingen-Schwenningen, Germany, 78052

Helios Klinik Wuppertal

Wuppertal, Germany, 42283

Israel

Soroka University Medical Centre

Beer Sheva, Israel, 8410101

Assaf Harofeh Medical Center

Beer Yaakov, Israel, 70300

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, Israel, 9112000

Meir Medical Center; Oncology

Kfar-Saba, Israel, 4428164

Galilee Medical Center

Nahariya, Israel, 22100

Rabin Medical Center

Petach Tiqwa, Israel, 49100

Chaim Sheba Medical Center

Ramat Gan, Israel, 5265601

Rambam Health Corporation; Oncology Institute

Rambam, Israel, 3525408

Kaplan Medical Center

Rehovot, Israel, 7610001

Tel Aviv Sourasky Medical Ctr; Oncology

Tel Aviv, Israel, 6423906

Italy

Ospedale Clinicizzato SS Annunziata

Chieti, Abruzzo, Italy, 66100

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

Avellino, Campania, Italy, 83100

Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

Napoli, Campania, Italy, 80131

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

Napoli, Campania, Italy, 80131

Ospedale Di Macerata; Oncologia

Macerata, Marche, Italy, 62100

Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

Perugia, Umbria, Italy, 06129

Spain

Consorcio Hospitalario Provincial de Castellon

Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002

Hospital Son Llatzer

Palma de Mallorca, Islas Baleares, Spain, 07198

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruña, Spain, 15006

Hospital Universitario de Torrejon

Torrejon de Ardoz, Madrid, Spain, 28850

Hospital Universitario de Canarias

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

Hospital Santa Creu i Sant Pau

Barcelona, Spain, 08041

Hospital de San Pedro de Alcantara

Caceres, Spain, 10003

Hospital Universitario Virgen de Las Nieves

Granada, Spain, 18012

Hospital General Universitario de Guadalajara

Guadalajara, Spain, 19002

Complejo Hospitalario de Jaen

Jaen, Spain, 23007

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Hospital NisA 9 de Octubre

Valencia, Spain, 46015

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, Spain, 50009

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 and Statistical Analysis Plan  [PDF] October 24, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02367781
• Other Study ID Numbers: GO29537; 2014-003206-32 ( EudraCT Number )
• First Posted: February 20, 2015
• Results First Posted: April 3, 2019
• Last Update Posted: August 9, 2021
• Last Verified: July 2021

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Paclitaxel; Carboplatin; Pemetrexed; Atezolizumab; Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Physiological Effects of Drugs; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Immune Checkpoint Inhibitors; Antineoplastic Agents, Immunological