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A Phase III, Open-label, Multicenter, Randomzed Study Evaluating the Efficacy and Safety of MPDL3208A (Anti-PDL-1 Antibody) in Combination With Carboplatin + Paclitaxel or MPDL3208A in Combination With Carboplatin + Nab-paclitaxel Versus Carboplatin + Nab-paclitaxel in Chemotherapy-naive Patients With Stage IV Squamous Non-small Cell Lung Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase III, Open-label, Multicenter, Randomzed Study Evaluating the Efficacy and Safety of MPDL3208A (Anti-PDL-1 Antibody) in Combination With Carboplatin + Paclitaxel or MPDL3208A in Combination With Carboplatin + Nab-paclitaxel Versus Carboplatin + Nab-paclitaxel in Chemotherapy-naive Patients With Stage IV Squamous Non-small Cell Lung Cancer
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym KP IRB No.
CN-15-2289-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Non-Small Cell Lung Cancer
 
Purpose
This randomized, open-label study will evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naïve patients with Stage IV squamous non-small cell lung cancer (NSCLC)
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
  • Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function
 
Exclusion Criteria
  • Active or untreated central nervous system (CNS) metastasis
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Active hepatitis B or hepatitis C
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti PD-1, and anti-PD-L1 therapeutic antibody
  • Severe infection within 4 weeks prior to randomization
  • Significant history of cardiovascular disease

 
Keywords and/or Specific Medical Conditions
  • Non-Small Cell Lung Cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga
Contact Information:
- Desiree Goldstein
-desiree.goldstein@kp.org
-Vallejo Medical Center


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