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)

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

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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Squamous Non-Small Cell Lung
• Intervention / Treatment: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel; Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 723
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
  • Ronse, Belgium, 9600
    • Werken Glorieux VZW
  • Wilrijk, Belgium, 2610
    • GasthuisZusters Antwerpen
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer - Surrey
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Etobicoke, Ontario, Canada, M9V 1R8
      • William Osler Health Centre
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Cite de La Sante de Laval; Hemato-Oncologie
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve - Rosemont
• France
  • Bordeaux, France, 33300
    • Polyclinique Bordeaux Nord Aquitaine
  • Levallois-Perret, France, 92300
    • Institut Hospitalier Franco-Britannique; Cancerologie
  • Marseille, France, 13285
    • Fondation Hopital Saint Joseph;Cardiologie Clinique
  • Montpellier, France, 34070
    • Clinique Clementville; Hopital De Jour
  • Nancy, France, 54100
    • Centre D'oncologie de Gentilly; Service Oncologie Medicale
  • Nantes, France, 44202
    • Clinique Catherine de Sienne
  • Neuilly sur Seine, France, 92200
    • Hopital American de Paris (American Hospital of Paris)
  • Orleans, France, 45100
    • HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
  • Rennes, France, 35033
    • Hopital Pontchaillou
  • Saint Pierre, France, 97448
    • Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
  • Saint-Mande, France, 94160
    • Hopital d'Instruction des Armees de Begin
  • Vandoeuvre-lès-nancy, France, 54511
    • CHRU Nancy; Pneumologie
• Germany
  • Berlin, Germany, 13353
    • Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Ebensfeld, Germany, 96250
    • Bezirksklinikum Obermain
  • Erfurt, Germany, 99089
    • Helios Klinikum Erfurt
  • Eschweiler, Germany, 52249
    • St. Antonius Hospital
  • Esslingen Am Neckar, Germany, 73730
    • Klinikum Esslingen GmbH; Frauenklinik
  • Flensburg, Germany, 24939
    • Malteser Krankenhaus St. Franziskus-Hospital
  • Frankfurt am Main, Germany, 60488
    • Krankenhaus Nordwest
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken GmbH
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
  • Gerlingen, Germany, 70839
    • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Immenhausen, Germany, 34376
    • Fachklinik für Lungenerkrankungen
  • Karlsruhe, Germany, 76137
    • St. Vincentius Kliniken Karlsruhe
  • Kassel, Germany, 34125
    • Klinikum Kassel; Hautklinik
  • Koblenz Am Rhein, Germany, 56073
    • Katholisches Klinikum Marienhof
  • Lubeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH Universitätsklinikum
  • Minden, Germany, 32429
    • Johannes Wesling Klinikum Minden
  • Munchen, Germany, 80337
    • LMU Klinikum der Universität München
  • Tuebingen, Germany, 72076
    • Universitatsklinikum Tubingen
  • Velbert, Germany, 42551
    • Praxis fur Haematologie und Internistische Onkologie
  • Villingen-Schwenningen, Germany, 78052
    • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
  • Wuppertal, Germany, 42283
    • HELIOS Klinik Wuppertal
• Israel
  • Beer Sheva, Israel, 8410101
    • Soroka University Medical Centre
  • Beer Yaakov, Israel, 70300
    • Assaf Harofeh Medical Center
  • Jerusalem, Israel, 9112000
    • Hadassah Ein Karem Hospital; Oncology Dept
  • Kfar-Saba, Israel, 4428164
    • Meir Medical Center; Oncology
  • Nahariya, Israel, 22100
    • Galilee Medical Center
  • Petach Tiqwa, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 5265601
    • Chaim Sheba Medical Center
  • Rambam, Israel, 3525408
    • Rambam Health Corporation; Oncology Institute
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Ctr; Oncology
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Ospedale Clinicizzato SS Annunziata
  • Campania
    • Avellino, Campania, Italy, 83100
      • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
    • Napoli, Campania, Italy, 80131
      • 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
  • Marche
    • Macerata, Marche, Italy, 62100
      • Ospedale Di Macerata; Oncologia
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera
• Spain
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau
  • Caceres, Spain, 10003
    • Hospital de San Pedro de Alcantara
  • Granada, Spain, 18012
    • Hospital Universitario Virgen de las Nieves
  • Guadalajara, Spain, 19002
    • Hospital General Universitario de Guadalajara
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46015
    • Hospital NisA 9 de Octubre
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Castellon
    • Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002
      • Consorcio Hospitalario Provincial de Castellón
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llatzer
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña
  • Madrid
    • Torrejon de Ardoz, Madrid, Spain, 28850
      • Hospital Universitario de Torrejon
  • Tenerife
    • S. Cristobal De La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Medical Center
    • Roseville, California, United States, 95661
      • Kaiser Permanente Medical Center - Roseville
    • Sacramento, California, United States, 95825
      • Kaiser Permanente - Sacramento Medical Center and Medical Offices
    • San Francisco, California, United States, 94118
      • Kaiser Permanente - San Francisco Medical Center
    • San Jose, California, United States, 95119
      • Kaiser Permanente - San Jose Medical Center
    • San Leandro, California, United States, 94577
      • Kaiser Permanente - San Leandro Medical Center
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente - Santa Clara
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente - South San Francisco
    • Vallejo, California, United States, 94589
      • Kaiser Permanente; Oncology Clinical Trials
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente - Walnut Creek
  • Colorado
    • Greeley, Colorado, United States, 85234
      • Banner MD Anderson Cancer Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Associates; (ECHO)
  • Florida
    • Deerfield Beach, Florida, United States, Suite 200
      • University of Miami School of Medicine - Sylvester at Deerfield
    • Fort Myers, Florida, United States, 33916
      • SCRI Florida Cancer Specialists South
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
    • West Palm Beach, Florida, United States, 33401
      • SCRI Florida Cancer Specialists East
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer & Blood Center, LLC; Research
    • Carrollton, Georgia, United States, 30117
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Lawrenceville, Georgia, United States, 30046
      • Suburban Hematology / Oncology Associates
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology; Associates, Ltd.
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University, Simmons Cancer Institute
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Med Oncology & Hematology Inc
  • Iowa
    • Iowa City, Iowa, United States, 52242-1083
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Lexington, Kentucky, United States, 02421
      • Lahey Clinic Med Ctr
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
    • Bethesda, Maryland, United States, 20814
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Fairhaven, Massachusetts, United States, 02719
      • Southcoast Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Hematology and Oncology Associates at Bridgepoint
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Cancer Ctr
  • Nevada
    • Reno, Nevada, United States, 89502
      • VA Sierra Nevada Health Care System
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Cancer Inst. of New Jersey
  • New York
    • New York, New York, United States, 10016
      • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center; Department of Medicine
    • Salisbury, North Carolina, United States
      • W.G. Bill Hefner VA Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Columbus, Ohio, United States, 43219
      • Mark H. Zangmeister Center
    • Hamilton, Ohio, United States, 45103
      • Oncology Hematology Care, Inc.
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Pinnacle Health
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605-4292
      • Greenville Health System; Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • SCRI Tennessee Oncology Chattanooga
    • Chattanooga, Tennessee, United States, 37403
      • University Oncology Associates
  • Texas
    • Denton, Texas, United States, 76210
      • SCRI The Center For Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • University of Texas M.D. Anderson Cancer Center
    • San Antonio, Texas, United States, 78217
      • Cancer Care Network of South Texas - SAT & BC

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (Atezolizumab+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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to approximately 35 months after first patient enrolled
Overall Survival (OS) in the ITT-WT Population	OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.	Up to approximately 35 months after first patient enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population	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.	Up to approximately 35 months after first subject enrolled
OS as Determined by the Investigator Using Recist v1.1 in the ITT Population	OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.	Up to approximately 41 months after first subject enrolled
OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population	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.	Up to approximately 35 months after first patient enrolled
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	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.	Up to approximately 41 months after first subject enrolled
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	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.	Up to approximately 35 months after first subject enrolled
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	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.	Up to approximately 35 months after first subject enrolled
Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population	The OS rate at the 1- and 2-year landmark time points after randomization.	Up to 41 months after first patient enrolled, years 1 and 2 reported
Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population	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.	Up to 35 months after first patient enrolled, years 1 and 2 reported
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population	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.	Up to approximately 35 months after first subject enrolled
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale	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.	Up to approximately 35 months after first subject enrolled
Percentage of Participants With Adverse Events	Percentage of participants with at least one adverse event. Adverse event onset date before cross over.	Up to approximately 69 months after first patient enrolled
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab	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	Up to approximately 35 months after first subject enrolled
Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm	Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.	Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel	Predose samples will be collected on the same day of treatment administration.	Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days)
Plasma Concentrations of Carboplatin		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)
Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel		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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2015
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): January 18, 2021

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Folic Acid Antagonists; Carboplatin; Paclitaxel; Antibodies; Antibodies, Monoclonal; Pemetrexed; Atezolizumab
• Other Study ID Numbers: GO29537; 2014-003206-32 (EudraCT Number)