Trial Search Results

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 test the effectiveness, safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. We would like to find out what effect, good or bad, the study drug has on men and women with non-small cell lung cancer whose tumors over express a protein called PD-L1. We would also like to find out from this study if nivolumab delays the progression of lung cancer compared to a standard treatment of two chemotherapy drugs given to patients who have an advanced stage of the lung cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bristol-Myers Squibb

Collaborator: Ono Pharmaceutical Co. Ltd


  • Biological: Nivolumab
  • Drug: Gemcitabine
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: Pemetrexed


Phase 3


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


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting