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)

Study 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. 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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAtezolizumab and Carboplatin

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 15, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?82 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Hoffmann-La Roche
Interventions being studied: Drug: Atezolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

California Cancer Associates for Research & Excellence, Inc.Encinitas, California
Marin Cancer Care IncGreenbrae, California
University of California San DiegoLa Jolla, California
Chao Family Comprehensive Cancer Center; UC Irvine Medical CenterOrange, California
Eastern Connecticut Hematology and Oncology Associates; (ECHO)Norwich, Connecticut
Georgetown University Medical CenterWashington D.C., District of Columbia
Mount Sinai Medical CenterMiami Beach, Florida
Florida HospitalOrlando, Florida
Straub Clinic & Hospital; OncologyHonolulu, Hawaii
Ingalls Memorial HospitalHarvey, Illinois
Consultants in Blood Disorders & CancerLouisville, Kentucky
University of MarylandBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 15, 2019. Always confirm current availability with the study team.

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