A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

February 11, 2019 updated by: Hoffmann-La Roche

A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Pardubice, Czechia, 532 03
        • Multiscan s.r.o.
  • France
      • Limoges, France, 87042
        • Hôpital du Cluzeau
      • Paris, France, 75970
        • Hopital Tenon; Oncologie Radiotherapie
      • Strasbourg, France, 67085
        • Centre Paul Strauss
  • Germany
      • Hannover, Germany, 30459
        • KRH Klinikum Siloah-Oststadt-Heidehaus
      • Paderborn, Germany, 33098
        • Brüderkrankenhaus St. Josef Paderborn
  • Greece
      • Athens, Greece, 11527
        • Sotiria Chest Hospital of Athens
      • Athens, Greece, 12464
        • Attikon University General Hospital
      • Thessaloniki, Greece, 57010
        • Georgios Papanikolaou General Hosp. of Thessaloniki
      • Thessaloniki, Greece, 546 22
        • Bioclinic Thessaloniki
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Matrahaza, Hungary, 3233
        • Matrai Gyogyintezet
      • Nyiregyhaza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
      • Pecs, Hungary, 7624
        • University of Pecs, I st Dept of Internal Medicine
      • Szolnok, Hungary, 5000
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
  • Italy
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Rimini, Emilia-Romagna, Italy, 47900
        • Ospedale infermi di Rimini
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO)
    • Lombardia
      • Bergamo, Lombardia, Italy, 24100
        • ASST Papa Giovanni XXIII
      • Cremona, Lombardia, Italy, 26100
        • Azienda Ospedaliera Istituti Ospitalieri
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele S.r.l.
      • Milano, Lombardia, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
      • Monza, Lombardia, Italy, 20900
        • Asst Di Monza
      • Rozzano (MI), Lombardia, Italy, 20089
        • Istituto Clinico Humanitas
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Veneto
      • Verona, Veneto, Italy, 37126
        • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Suwon-si,, Korea, Republic of, 442-723
        • The Catholic University of Korea St. Vincent's Hospital
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
  • Romania
      • Alba Iulia, Romania, 510073
        • County Hospital Alba; Oncology
      • Baia Mare, Romania, 430031
        • Dr Constantin Opris Emergency County Hospital Baia Mare
      • Brasov, Romania, 500091
        • Teo Health SA - Saint Constantin Hospital
      • Craiova, Romania, 200347
        • Oncology Center Sf. Nectarie
      • Iasi, Romania, 700483
        • Institutul Regional de Oncologie Iasi; Clinica de Hematologie
      • Sibiu, Romania, 550245
        • Sibiu Emergency Clinical County Hospital
      • Timisoara, Romania, 300239
        • Oncomed SRL
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Oncology Dispensary
      • Kursk, Russian Federation, 305035
        • Kursk Regional Clinical Oncology Dispensary
      • Nizhny Novgorod, Russian Federation, 603081
        • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
      • Saransk, Russian Federation, 430032
        • Mordovia State University
      • St Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
      • Kragujevac, Serbia, 34000
        • Clin Hospital Center - Kragujevac; Pulmonary Diseases
      • Sremska Kamenica, Serbia, 21204
        • Institute of Lung Diseases Vojvodina
  • Spain
      • Valencia, Spain, 46026
        • Fundacion Investigacion Hospital La Fe de Valencia
      • Zaragoza, Spain, 50009
        • Hosp Clinico Univ Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Grimsby, United Kingdom, DN33 2BA
        • Diana Princess of Wales Hosp.
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
  • United States
    • California
      • Encinitas, California, United States, 92008
        • California Cancer Associates for Research & Excellence, Inc.
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care Inc
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates; (ECHO)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic & Hospital; Oncology
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders & Cancer
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Easton, Maryland, United States, 21601
        • Bay Hematology Oncology
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • New Jersey
      • Summit, New Jersey, United States, 07902
        • Atlantic Health Cancer Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
      • Hickory, North Carolina, United States, 28602
        • Carolina Oncology Specialists, PA - Hickory
      • Pinehurst, North Carolina, United States, 28374
        • First Health of the Carolinas
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Wellmont Cancer Institute
      • Chattanooga, Tennessee, United States, 37403
        • University Oncology Associates
      • Germantown, Tennessee, United States, 38138
        • Sarah Cannon Cancer Center
      • Nashville, Tennessee, United States, 37232-7610
        • Vanderbilt Medical Center
    • Washington
      • Auburn, Washington, United States, 98002-4117
        • MultiCare Regional Cancer Center - Auburn
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed Stage IV squamous NSCLC
  • Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
  • No prior treatment for Stage IV squamous NSCLC
  • Measurable disease as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases
  • Untreated or inadequately treated spinal cord compression
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
  • Any other malignancies within 5 years except those with negligible risk of metastasis or death
  • Pregnant or lactating women
  • Known hypersensitivity to any component of atezolizumab formulation or other study medication
  • History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
  • Prior allogeneic bone marrow or solid organ transplantation
  • Positive human immunodeficiency virus (HIV) test
  • Active hepatitis B or C
  • Active tuberculosis
  • Significant cardiovascular disease
  • Severe infection or major surgery within 4 weeks prior to randomization
  • Use of any approved anti-cancer therapy within 3 weeks prior to treatment
  • Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
  • Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  • Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Names:
  • MPDL3280A; Tecentriq
ACTIVE_COMPARATOR: Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
Drug: Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Drug: Cisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Drug: Gemcitabine
Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO29432
  • 2014-003106-33 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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