CompletedPhase 3NCT02713867

A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Checked against the public recordLast updated Feb 14, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations129
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Interventions being studied
Biological: Nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy * Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD) * Measurable disease before start of pre-study nivolumab treatment * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2 Exclusion Criteria: * Carcinomatous meningitis * Untreated, symptomatic Central nervous system (CNS) metastases * Symptomatic interstitial lung disease Other protocol defined inclusion/exclusion criteria could apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Local Institution - 0004Birmingham, Alabama
  • Local Institution - 0030Phoenix, Arizona
  • Local Institution - 0041Phoenix, Arizona
  • CBCC Global Research, Inc.Bakersfield, California
  • Southern California Permanente Medical GroupBellflower, California
  • St Jude Hospital Yorba LindaFullerton, California
  • Local Institution - 0046Los Angeles, California
  • Local Institution - 0126Orange, California
  • Torrance Health AssociationRedondo Beach, California
  • Sharp Memorial HospitalSan Diego, California
  • Local Institution - 0010Santa Barbara, California
  • Local Institution - 0044Santa Maria, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 14, 2023. Always confirm current availability with the study team.

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