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)
Trial ID or NCT#
NCT02041533
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Joel Neal, MD, PhD
Medical oncologist,
Thoracic specialist
Associate Professor of Medicine (Oncology)
Kavitha Ramchandran
Medical oncologist,
Palliative medicine doctor,
Thoracic specialist,
Internal medicine doctor
Clinical Professor, Medicine - Oncology
Millie Das
Medical oncologist,
Thoracic specialist
Clinical Associate Professor, Medicine - Oncology
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov