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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 (CheckMate 026)
Not Recruiting
Trial ID: NCT02041533
Purpose
The purpose of this study is to show that Nivolumab will improve progression free survival in
subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared
to chemotherapy
Official Title
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
Stanford Investigator(s)
Heather Wakelee
Professor of Medicine (Oncology)
Kavitha Ramchandran
Clinical Associate Professor, Medicine - Oncology
Millie Das
Clinical Associate Professor, Medicine - Oncology
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Eligibility
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
Intervention(s):
biological: Nivolumab
drug: Gemcitabine
drug: Cisplatin
drug: Carboplatin
drug: Paclitaxel
drug: Pemetrexed
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061