A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/18/2018 |
Start Date: | August 6, 2013 |
End Date: | August 31, 2018 |
A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
This multicenter, open-label, randomized study will evaluate the efficacy and safety of
Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small
cell lung cancer after platinum failure. Participants will be randomized to receive either
Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per
meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be
continued 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.
Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small
cell lung cancer after platinum failure. Participants will be randomized to receive either
Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per
meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be
continued 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:
- Adult participants, >/= 18 years of age
- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell
lung cancer (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
- Measurable disease, as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Known active or untreated central nervous system (CNS) metastases as determined by CT
or MRI evaluation during screening and prior radiographic assessments
- 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 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 CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic
antibody or pathway-targeting agents
We found this trial at
30
sites
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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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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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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10103 RidgeGate Parkway
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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