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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
Overall Recruitment Status: Active, enrollment completed
 
Official Title
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
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym KP IRB No.
CN-13-1590-B
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Non-Small Cell Lung Cancer
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
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

 
Keywords and/or Specific Medical Conditions
  • Non-small cell lung cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Louis Fehrenbacher, MD
Contact Information:


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