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)

• Status: Active, not recruiting
• Trial end date: 2021-08-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Gemcitabine; Nivolumab; Paclitaxel; Pemetrexed

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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