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CompletedPhase 3NCT02713867
Official study title

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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?129 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • 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
Reasons someone may not be able to joinExclusion criteria
  • Carcinomatous meningitis
  • Untreated, symptomatic Central nervous system (CNS) metastases
  • Symptomatic interstitial lung disease Other protocol defined inclusion/

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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