An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease

Sponsor
Bristol-Myers Squibb
Study ID
NCT03770299
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Vinorelbine — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days
  • Observation — OTHER
    Observation by the investigator

Study Details

The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.

Key Dates

Start date
Jan 15, 2021
Status verified
Mar 2022
Primary completion
Mar 14, 2023
Completion
Mar 14, 2024

Study Design

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

Arms

  • Experimental: Arm A
    Nivolumab + SOC (chemotherapy in eligible participants or observation)
  • Active Comparator: Arm B
    SOC (chemotherapy in eligible participants or observation)

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: Approximately 24 months ]

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