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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
Winston Chen and Phyllis Huang Professor
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
Millie Das
Clinical Professor, 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