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)
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | May 7, 2015 |
End Date: | December 7, 2017 |
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 Therefore the planned objectives of this study are no
longer applicable and formal analyses of efficacy or safety have not been performed.
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 Therefore the planned objectives of this study are no
longer applicable and formal analyses of efficacy or safety have not been performed.
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
We found this trial at
29
sites
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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2406 Century Place Southeast
Hickory, North Carolina 28602
Hickory, North Carolina 28602
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Florida Hospital Florida Hospital is one of the country
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Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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