AzTrials
AzTrials

Carcinoma, Non-Squamous Non-Small Cell LungPhase 3IMpower130NCT02367781

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)

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin and Nab-Paclitaxel in people with Carcinoma, Non-Squamous Non-Small Cell Lung, run by Hoffmann-La Roche at 132 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
723 participants
Where
132 sitesin 8 countries
Study dates
16 Apr 2015to 18 Jan 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

132 sites in 8 countries.

132 sites in 8 countries

United States57 sites

  • University Cancer & Blood Center, LLC; Research

    Athens, Georgia, 30607

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814

  • Center For Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Carrollton, Georgia, 30117

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • University Oncology Associates

    Chattanooga, Tennessee, 37403

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • University of Miami School of Medicine - Sylvester at Deerfield

    Deerfield Beach, Florida, Suite 200

  • SCRI The Center For Cancer and Blood Disorders

    Denton, Texas, 76210

  • Duke University Medical Center; Department of Medicine

    Durham, North Carolina, 27710

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Southcoast Health System

    Fairhaven, Massachusetts, 02719

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • Fort Wayne Med Oncology & Hematology Inc

    Fort Wayne, Indiana, 46845

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 85234

  • Greenville Health System; Cancer Center

    Greenville, South Carolina, 29605-4292

  • Oncology Hematology Care, Inc.

    Hamilton, Ohio, 45103

  • Pinnacle Health

    Harrisburg, Pennsylvania, 17110

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242-1083

  • Joliet Oncology-Hematology; Associates, Ltd.

    Joliet, Illinois, 60435

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Suburban Hematology / Oncology Associates

    Lawrenceville, Georgia, 30046

  • Lahey Clinic Med Ctr

    Lexington, Kentucky, 02421

  • Southeast Nebraska Cancer Ctr

    Lincoln, Nebraska, 68510

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Cancer Inst. of New Jersey

    New Brunswick, New Jersey, 08901

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016

  • Southeastern Regional Medical Center, Inc.

    Newnan, Georgia, 30265

  • Eastern Connecticut Hematology and Oncology Associates; (ECHO)

    Norwich, Connecticut, 06360

  • Kaiser Permanente Oakland Medical Center

    Oakland, California, 94611

  • Florida Hospital

    Orlando, Florida, 32803

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Va Sierra Nevada Health Care System

    Reno, Nevada, 89502

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • Kaiser Permanente - Sacramento Medical Center and Medical Offices

    Sacramento, California, 95825

  • W.G. Bill Hefner VA Medical Center

    Salisbury, North Carolina

  • Cancer Care Network of South Texas - SAT & BC

    San Antonio, Texas, 78217

  • Kaiser Permanente - San Francisco Medical Center

    San Francisco, California, 94118

  • Kaiser Permanente - San Jose Medical Center

    San Jose, California, 95119

  • Kaiser Permanente - San Leandro Medical Center

    San Leandro, California, 94577

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente - South San Francisco

    South San Francisco, California, 94080

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Southern Illinois University, Simmons Cancer Institute

    Springfield, Illinois, 62794

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

    St. Petersburg, Florida, 33705

  • Hematology and Oncology Associates at Bridgepoint

    Tupelo, Mississippi, 38801

  • Kaiser Permanente; Oncology Clinical Trials

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

  • SCRI Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

  • Clinical Research Alliance

    Westbury, New York, 11590

Other trials in United States

Germany25 sites

  • Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie

    Berlin, 13353

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Bezirksklinikum Obermain

    Ebensfeld, 96250

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • St. Antonius Hospital

    Eschweiler, 52249

  • Klinikum Esslingen GmbH; Frauenklinik

    Esslingen am Neckar, 73730

  • Malteser Krankenhaus St. Franziskus-Hospital

    Flensburg, 24939

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Asklepios Fachkliniken GmbH

    Gauting, 82131

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548

  • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

    Gerlingen, 70839

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • St. Vincentius Kliniken Karlsruhe

    Karlsruhe, 76137

  • Klinikum Kassel; Hautklinik

    Kassel, 34125

  • Katholisches Klinikum Marienhof

    Koblenz Am Rhein, 56073

  • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

    Lübeck, 23538

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • LMU Klinikum der Universitat Munchen

    München, 80337

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Praxis fur Haematologie und Internistische Onkologie

    Velbert, 42551

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

    Villingen-Schwenningen, 78052

  • Helios Klinik Wuppertal

    Wuppertal, 42283

Other trials in Germany

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, LA Coruña, 15006

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital de San Pedro de Alcantara

    Cáceres, 10003

  • Consorcio Hospitalario Provincial de Castellon

    Castellon de LA Plana/castello de LA Plana, Castellon, 12002

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18012

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Hospital Universitario de Canarias

    S. Cristobal de La Laguna, Tenerife, 38320

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital NisA 9 de Octubre

    Valencia, 46015

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

France12 sites

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Institut Hospitalier Franco-Britannique; Cancerologie

    Levallois-Perret, 92300

  • Fondation Hopital Saint Joseph;Cardiologie Clinique

    Marseille, 13285

  • Clinique Clementville; Hopital De Jour

    Montpellier, 34070

  • Centre D'oncologie de Gentilly; Service Oncologie Medicale

    Nancy, 54100

  • Clinique Catherine de Sienne

    Nantes, 44202

  • Hopital American de Paris (American Hospital of Paris)

    Neuilly-sur-Seine, 92200

  • HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

    Orléans, 45100

  • Hopital Pontchaillou

    Rennes, 35033

  • Hopital d'Instruction des Armees de Begin

    Saint-Mandé, 94160

  • Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

    Saint-Pierre, 97448

  • CHRU Nancy; Pneumologie

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Israel10 sites

  • Assaf Harofeh Medical Center

    Beer Yaakov, 70300

  • Soroka University Medical Centre

    Beersheba, 8410101

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112000

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 22100

  • Rabin Medical Center

    Petach Tiqwa, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Rambam Health Corporation; Oncology Institute

    Rambam, 3525408

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Ctr; Oncology

    Tel Aviv, 6423906

Other trials in Israel

Italy6 sites

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

    Avellino, Campania, 83100

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100

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

    Naples, Campania, 80131

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

    Naples, Campania, 80131

  • Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

    Perugia, Umbria, 06129

  • Ospedale Di Macerata; Oncologia

    Province of Macerata, The Marches, 62100

Other trials in Italy

Canada5 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Etobicoke, Ontario, M9V 1R8

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec, H7M 3L9

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • BC Cancer - Surrey

    Surrey, British Columbia, V3V 1Z2

Other trials in Canada

Belgium4 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • CHU Ambroise Paré

    Mons, 7000

  • Werken Glorieux VZW

    Ronse, 9600

  • GasthuisZusters Antwerpen

    Wilrijk, 2610

Other trials in Belgium

About this study

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

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).

Being tested
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Nab-Paclitaxel, Pemetrexed
Medical subject headings
Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibodyDrug

    Also called MPDL3280A, RO5541267, Tecentriq

    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.

  • CarboplatinDrug

    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-PaclitaxelDrug

    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.

  • PemetrexedDrug

    Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.

Study groups in NCT02367781
Study groupRoleWhat they receive
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)ExperimentalParticipants 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel
Arm B (Nab-Paclitaxel+Carboplatin)Active comparatorParticipants 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Up to approximately 35 months after first patient enrolled

  2. 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.

    Measured: Up to approximately 35 months after first patient enrolled

Secondary outcomes (16)

  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

    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.

    Measured: Up to approximately 35 months after first subject enrolled

  2. 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.

    Measured: Up to approximately 41 months after first subject enrolled

  3. 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.

    Measured: Up to approximately 35 months after first patient enrolled

  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

    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.

    Measured: Up to approximately 41 months after first subject enrolled

  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

    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.

    Measured: Up to approximately 35 months after first subject enrolled

  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

    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.

    Measured: Up to approximately 35 months after first subject enrolled

  7. 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.

    Measured: Up to 41 months after first patient enrolled, years 1 and 2 reported

  8. 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.

    Measured: Up to 35 months after first patient enrolled, years 1 and 2 reported

  9. 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.

    Measured: Up to approximately 35 months after first subject enrolled

  10. 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.

    Measured: Up to approximately 35 months after first subject enrolled

  11. Percentage of Participants With Adverse Events

    Percentage of participants with at least one adverse event. Adverse event onset date before cross over.

    Measured: Up to approximately 69 months after first patient enrolled

  12. 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

    Measured: Up to approximately 35 months after first subject enrolled

  13. 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.

    Measured: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)

  14. 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.

    Measured: Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days)

  15. Plasma Concentrations of Carboplatin

    Measured: 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study start16 Apr 2015
  3. Primary completion15 Mar 2018
  4. Study completion18 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
723 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02367781
Sponsor's protocol ID
GO29537
Other IDs
2014-003206-32, 2014
Acronym
IMpower130
Status last verified
Jul 2021
First submitted
13 Feb 2015
Last updated
9 Aug 2021

Publications

  • 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.

    PubMed 36795388

  • 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.

    PubMed 35511917

  • 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.

    PubMed 31122901

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin and Nab-Paclitaxel in people with Carcinoma, Non-Squamous Non-Small Cell Lung, run by Hoffmann-La Roche at 132 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Germany, Spain, France, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02367781, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.

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