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
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Biological: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.