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Active, Not Recruiting

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 - CA209-384

Updated: 2 June, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Active Comparator: Nivolumab 240 mg
Biological: Nivolumab
Experimental: Nivolumab 480 mg
Biological: Nivolumab

Key Eligibility Criteria

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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