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)

Not Recruiting

Trial ID: NCT02041533

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology

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

Intervention(s):

biological: Nivolumab

drug: Gemcitabine

drug: Cisplatin

drug: Carboplatin

drug: Paclitaxel

drug: Pemetrexed

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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