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Not Recruiting
Trial ID: NCT02041533
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Professor of Medicine (Oncology)
Clinical Associate Professor, Medicine - Oncology
Clinical Associate Professor, Medicine - Oncology
Associate Professor of Medicine (Oncology)
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
- Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic
anticancer therapy
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per
response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
- PD-L1+ on immunohistochemistry testing performed by central lab
- Men and women, ages ≥ 18 years of age
Exclusion Criteria:
- Known epidermal growth factor receptor (EGFR) mutations which are sensitive to
available targeted inhibitor therapy
- Known anaplastic lymphoma kinase (ALK) translocations
- Untreated central nervous system (CNS) metastases
- Previous malignancies
- Active, known or suspected autoimmune disease
biological: Nivolumab
drug: Gemcitabine
drug: Cisplatin
drug: Carboplatin
drug: Paclitaxel
drug: Pemetrexed
Not Recruiting
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