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

Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Associate Professor, Medicine - Oncology

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

Associate Professor of 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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