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)
Kavitha Ramchandran
Medical oncologist,
Palliative medicine doctor,
Thoracic specialist,
Internal medicine doctor
Clinical Associate Professor, Medicine - Oncology
Millie Das
Medical oncologist,
Thoracic specialist
Clinical Associate Professor, Medicine - Oncology
Joel Neal, MD, PhD
Medical oncologist,
Thoracic specialist
Associate Professor of Medicine (Oncology)
Contact us to find out if this trial is right for you.
Contact
CCTO
(650) 498-7061
View on ClinicalTrials.gov