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

A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03770299

Acronym

CheckMate 9TN

Enrollment

0

Registered

2018-12-10

Start date

2021-01-15

Completion date

2024-03-14

Last updated

2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor DNA, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma

Brief summary

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.

Interventions

BIOLOGICALNivolumab

Specified dose on specified days

DRUGVinorelbine

Specified dose on specified days

DRUGGemcitabine

Specified dose on specified days

DRUGDocetaxel

Specified dose on specified days

DRUGPemetrexed

Specified dose on specified days

DRUGCisplatin

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGPaclitaxel

Specified dose on specified days

OTHERObservation

Observation by the investigator

Sponsors

Bristol-Myers Squibb

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

prior to Surgery: * Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable * Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC * Treatment naive (no previous systemic treatment) Inclusion Criteria prior to Treatment Randomization: * Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC * Must have adequately recovered from surgery at the time of randomization * Minimal residual disease (MRD) positive results as detected by ctDNA

Exclusion criteria

prior to Surgery: * Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites) * Active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS)	Approximately 24 months

Secondary

Measure	Time frame
ctDNA duration of response (DOR)	Approximately 36 months
ctDNA time to response (TTR)	Approximately 36 months
Incidence of adverse events (AEs)	Approximately 36 months
Incidence of serious adverse events (SAEs)	Approximately 36 months
Circulating tumor DNA (ctDNA) response rate	Approximately 36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026