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)

Stopped early · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Key facts

Study ID

NCT02409355

Run by

Hoffmann-La Roche

People needed

8

Starts

2015-05-07

Expected to finish

2017-12-07

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marin Cancer Care Inc — Greenbrae, California, United States
• University of California San Diego — La Jolla, California, United States
• Chao Family Comprehensive Cancer Center; UC Irvine Medical Center — Orange, California, United States
• Eastern Connecticut Hematology and Oncology Associates; (ECHO) — Norwich, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Straub Clinic & Hospital; Oncology — Honolulu, Hawaii, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Consultants in Blood Disorders & Cancer — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Bay Hematology Oncology — Easton, Maryland, United States
• Montana Cancer Specialists — Missoula, Montana, United States
• Atlantic Health Cancer Center — Summit, New Jersey, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• Carolina Oncology Specialists, PA - Hickory — Hickory, North Carolina, United States
• First Health of the Carolinas — Pinehurst, North Carolina, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Wellmont Cancer Institute — Bristol, Tennessee, United States
• University Oncology Associates — Chattanooga, Tennessee, United States
• Sarah Cannon Cancer Center — Germantown, Tennessee, United States
• California Cancer Associates for Research & Excellence, Inc. — Encinitas, California, United States

Full record on ClinicalTrials.gov

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