Education and Training

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)

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

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • biological: Nivolumab
  • drug: Gemcitabine
  • drug: Cisplatin
  • drug: Carboplatin
  • drug: Paclitaxel
  • drug: Pemetrexed

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting