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Clinical Trial VICCTHO1420

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

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. VICCTHO1420
  • Open Date: 05/19/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the PFS, based on IRRC assessment, of nivolumab monotherapy with investigator's choice chemotherapy in subjects with stage IV or recurrent NSCLC with strongly PD-L1+ tumor expression.
  • Disease Sites: Lung
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Alimta; Gemcitabine; Nivolumab (BMS-936558); Paclitaxel; Pemetrexed
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02041533
  • Secondary Protocol No: CA209026

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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