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
Completed · Phase 3
Conditions studied: Lung Cancer
In brief
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).
Key facts
- Study ID
- NCT02713867
- Run by
- Bristol-Myers Squibb
- People needed
- 363
- Starts
- 2016-05-24
- Expected to finish
- 2022-01-18
- Last updated by the study team
- 2023-02-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Carcinomatous meningitis
- Untreated, symptomatic Central nervous system (CNS) metastases
- Symptomatic interstitial lung disease
- Other protocol defined inclusion/exclusion criteria could apply
Where it is running
- Local Institution - 0030 — Phoenix, Arizona, United States
- Local Institution - 0041 — Phoenix, Arizona, United States
- CBCC Global Research, Inc. — Bakersfield, California, United States
- Southern California Permanente Medical Group — Bellflower, California, United States
- St Jude Hospital Yorba Linda — Fullerton, California, United States
- Local Institution - 0046 — Los Angeles, California, United States
- Local Institution - 0126 — Orange, California, United States
- Torrance Health Association — Redondo Beach, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Local Institution - 0010 — Santa Barbara, California, United States
- Local Institution - 0044 — Santa Maria, California, United States
- Local Institution - 0130 — Vallejo, California, United States
- Local Institution - 0017 — Denver, Colorado, United States
- Local Institution - 0122 — Fort Collins, Colorado, United States
- Local Institution - 0038 — Fort Myers, Florida, United States
- Local Institution - 0089 — Hollywood, Florida, United States
- Local Institution - 0026 — Ocala, Florida, United States
- Local Institution - 0001 — Pensacola, Florida, United States
- Local Institution - 0039 — St. Petersburg, Florida, United States
- Local Institution - 0008 — Athens, Georgia, United States
- Local Institution - 0142 — Columbus, Georgia, United States
- Local Institution - 0121 — Marietta, Georgia, United States
- Ingalls Health System — Harvey, Illinois, United States
- Local Institution - 0098 — Niles, Illinois, United States
- Local Institution - 0004 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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