A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Part of paid clinical trials in La Jolla, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04026412
Phase
PHASE3
Status
Completed

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — BIOLOGICAL
    Specified dose on specified days
  • ipilimumab — BIOLOGICAL
    Specified dose on specified days
  • durvalumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Key Dates

Start date
Oct 8, 2019
Status verified
Jul 2025
Primary completion
Mar 22, 2024
Completion
Nov 26, 2024

Study Design

Enrollment
925 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: nivolumab + CCRT + ipilimumab
    Concurrent chemoradiotherapy (CCRT)
  • Experimental: Arm B: nivolumab + CCRT
    Concurrent chemoradiotherapy (CCRT)
  • Experimental: Arm C: CCRT + durvalumab
    Concurrent chemoradiotherapy (CCRT)

Primary Outcome Measure

Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR) [ Time Frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months) ]

Locations (24)

FacilityCityStateZIPSite coordinators
Local Institution - 0119La JollaCalifornia92093-
Local Institution - 0166San FranciscoCalifornia94143-
Local Institution - 0207San FranciscoCalifornia94115-
Local Institution - 0129Lone TreeColorado80124-
Local Institution - 0233JacksonvilleFlorida32207-
Local Institution - 0219OrlandoFlorida32804-
Local Institution - 0039PensacolaFlorida32504-
Local Institution - 0125AtlantaGeorgia30322-
Local Institution - 0165AugustaGeorgia30912-
Local Institution - 0218EdgewoodKentucky41017-
Local Institution - 0108BethesdaMaryland20817-
Local Institution - 0116Traverse CityMichigan49684-
Local Institution - 0053CincinnatiOhio45220-
Local Institution - 0131CincinnatiOhio45242-
Local Institution - 0188CincinnatiOhio45267-
Local Institution - 0047ClevelandOhio44109-
Local Institution - 0112ClevelandOhio44106-
Local Institution - 0124ClevelandOhio44106-
Local Institution - 0123YoungstownOhio44501-
Local Institution - 0077CharlestonSouth Carolina29414-
Local Institution - 0191AustinTexas78731-
Local Institution - 0079BryanTexas77802-
Local Institution - 0130DallasTexas75203-
Local Institution - 0071BurlingtonVermont05405-

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Find similar trials in La Jolla, CA

By research site
Local Institution - 0119· La Jolla, CALocal Institution - 0166· San Francisco, CALocal Institution - 0207· San Francisco, CALocal Institution - 0129· Lone Tree, COLocal Institution - 0233· Jacksonville, FLLocal Institution - 0219· Orlando, FL

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