A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | March 11, 2014 |
End Date: | January 9, 2019 |
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
This global, multicenter, open-label, randomized, controlled study will evaluate the efficacy
and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared
with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer
(NSCLC) after failure with platinum-containing chemotherapy. Participants will be randomized
1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as
participants are experiencing clinical benefit as assessed by the investigator, i.e., in the
absence of unacceptable toxicity or symptomatic deterioration attributed to disease
progression.
and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared
with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer
(NSCLC) after failure with platinum-containing chemotherapy. Participants will be randomized
1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as
participants are experiencing clinical benefit as assessed by the investigator, i.e., in the
absence of unacceptable toxicity or symptomatic deterioration attributed to disease
progression.
Inclusion Criteria:
- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
- Disease progression during or following treatment with a prior platinum-containing
regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease
recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant
regimen or combined modality (e.g., chemoradiation) regimen with curative intent
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Known active or untreated central nervous system (CNS) metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death and treated with
expected curative outcome
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation
field (fibrosis) is permitted
- Active hepatitis B or hepatitis C
- Prior treatment with docetaxel
- Prior treatment with cluster of differentiation 137 (CD137) agonists,
anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1
(anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
We found this trial at
63
sites
4100 John R Street
Detroit, Michigan 48201
Detroit, Michigan 48201
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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2151 North Harbor Boulevard
Fullerton, California 92835
Fullerton, California 92835
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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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7015 A C Skinner Parkway
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
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2045 Franklin Street
Lone Tree, Colorado 80205
Lone Tree, Colorado 80205
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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1 Valley Health Plaza
Paramus, New Jersey 07652
Paramus, New Jersey 07652
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UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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