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Non-Small Cell Lung CancerPhase 3NCT02409355

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)

A Phase 3 study testing Atezolizumab, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 82 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Atezolizumab, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
82 sitesin 14 countries
Study dates
7 May 2015to 7 Dec 2017
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

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

82 sites in 14 countries.

82 sites in 14 countries

United States28 sites

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98002-4117

  • University of Maryland

    Baltimore, Maryland, 21201

  • Wellmont Cancer Institute

    Bristol, Tennessee, 37620

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • University Oncology Associates

    Chattanooga, Tennessee, 37403

  • Bay Hematology Oncology

    Easton, Maryland, 21601

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92008

  • Sarah Cannon Cancer Center

    Germantown, Tennessee, 38138

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Carolina Oncology Specialists, PA - Hickory

    Hickory, North Carolina, 28602

  • Straub Clinic & Hospital; Oncology

    Honolulu, Hawaii, 96813

  • University of California San Diego

    La Jolla, California, 92093

  • Consultants in Blood Disorders & Cancer

    Louisville, Kentucky, 40207

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232-7610

  • Eastern Connecticut Hematology and Oncology Associates; (ECHO)

    Norwich, Connecticut, 06360

  • Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

    Orange, California, 92868

  • Florida Hospital

    Orlando, Florida, 32803

  • First Health of the Carolinas

    Pinehurst, North Carolina, 28374

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Atlantic Health Cancer Center

    Summit, New Jersey, 07902

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Italy12 sites

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24100

  • Azienda Ospedaliera Istituti Ospitalieri

    Cremona, Lombardy, 26100

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele S.r.l.

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Asst Di Monza

    Monza, Lombardy, 20900

  • Ospedale Infermi di Rimini

    Rimini, Emilia-Romagna, 47900

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

  • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

    Verona, Veneto, 37126

Other trials in Italy

Romania7 sites

  • County Hospital Alba; Oncology

    Alba Iulia, 510073

  • Dr Constantin Opris Emergency County Hospital Baia Mare

    Baia Mare, 430031

  • Teo Health SA - Saint Constantin Hospital

    Brasov, 500091

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie

    Iași, 700483

  • Sibiu Emergency Clinical County Hospital

    Sibiu, 550245

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Hungary6 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Matrai Gyogyintezet

    Mátraháza, 3233

  • Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • University of Pecs, I st Dept of Internal Medicine

    Pécs, 7624

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

    Szolnok, 5000

Other trials in Hungary

Russia5 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • Kursk Regional Clinical Oncology Dispensary

    Kursk, 305035

  • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

    Nizhny Novgorod, 603081

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Mordovia State University

    Saransk, 430032

Other trials in Russia

Greece4 sites

  • Sotiria Chest Hospital of Athens

    Athens, 11527

  • Attikon University General Hospital

    Athens, 12464

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22

  • Georgios Papanikolaou General Hosp. of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

United Kingdom4 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Diana Princess of Wales Hosp.

    Grimsby, DN33 2BA

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

Other trials in United Kingdom

France3 sites

  • Hôpital du Cluzeau

    Limoges, 87042

  • Hopital Tenon; Oncologie Radiotherapie

    Paris, 75970

  • Centre Paul Strauss

    Strasbourg, 67085

Other trials in France

Serbia3 sites

  • Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

    Belgrade, 11000

  • Institute of Lung Diseases Vojvodina

    Kamenitz, 21204

  • Clin Hospital Center - Kragujevac; Pulmonary Diseases

    Kragujevac, 34000

Other trials in Serbia

South Korea3 sites

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 442-723

Other trials in South Korea

Spain3 sites

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Fundacion Investigacion Hospital La Fe de Valencia

    Valencia, 46026

  • Hosp Clinico Univ Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Germany2 sites

  • KRH Klinikum Siloah-Oststadt-Heidehaus

    Hanover, 30459

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098

Other trials in Germany

Czechia1 site

  • Multiscan s.r.o.

    Pardubice, 532 03

Other trials in Czechia

Poland1 site

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

Other trials in Poland

About this study

Official title: 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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AtezolizumabDrug

    Also called MPDL3280A; Tecentriq

    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.

  • CarboplatinDrug

    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.

  • CisplatinDrug

    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.

  • GemcitabineDrug

    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.

Study groups in NCT02409355
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
Receives: Drug: Atezolizumab
Gemcitabine + Cisplatin/CarboplatinActive comparatorParticipants 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.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine

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)

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)

Timeline

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

  1. First posted6 Apr 2015 (estimated)
  2. Study start7 May 2015
  3. Primary completion7 Dec 2017
  4. Study completion7 Dec 2017

Why it stopped: 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.

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02409355
Sponsor's protocol ID
GO29432
Other IDs
2014-003106-33, 2014
Status last verified
Feb 2019
First submitted
1 Apr 2015
Last updated
15 Feb 2019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 82 sites in 14 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 21 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: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Italy, Romania, Hungary, Russia and 9 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 14 Nov 2018). 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) (time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)). 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 NCT02409355.

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 15 Feb 2019.

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