A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04025879
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days

Study Details

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Key Dates

Start date
Nov 5, 2019
Status verified
Jan 2025
Primary completion
Jul 26, 2023
Completion
Jul 30, 2027

Study Design

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

Arms

  • Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
  • Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.

Primary Outcome Measure

Event-Free Survival (EFS) by BICR [ Time Frame: From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 0104TampaFlorida33612-
Local Institution - 0040AtlantaGeorgia30342-
Local Institution - 0120AugustaGeorgia30912-
Local Institution - 0078ChicagoIllinois60612-
Local Institution - 0145ChicagoIllinois60611-
Local Institution - 0121Orland ParkIllinois60462-
Rcca Md LlcBethesdaMaryland20817-
Local Institution - 0076BostonMassachusetts02215-
Local Institution - 0074NewtonMassachusetts02459-
Local Institution - 0086Traverse CityMichigan49684-
Local Institution - 0100LebanonNew Hampshire03756-
Local Institution - 0055CincinnatiOhio45220-
Local Institution - 0102ClevelandOhio44106-
Local Institution - 0054HoustonTexas77030-
Local Institution - 0103FredericksburgVirginia22408-

Find similar trials in Tampa, FL

By research site
Local Institution - 0104· Tampa, FLLocal Institution - 0040· Atlanta, GALocal Institution - 0120· Augusta, GALocal Institution - 0078· Chicago, ILLocal Institution - 0145· Chicago, ILLocal Institution - 0121· Orland Park, IL

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