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An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease (CheckMate 9TN)

Primary Purpose

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

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nivolumab

Vinorelbine

Gemcitabine

Docetaxel

Pemetrexed

Cisplatin

Carboplatin

Paclitaxel

Observation

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria prior to Treatment Randomization:

Must continue to meet Exclusion Criteria prior to Surgery
Must have no evidence of metastatic disease after surgery
Received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Nivolumab + SOC (chemotherapy in eligible participants or observation)

SOC (chemotherapy in eligible participants or observation)

Outcomes

Primary Outcome Measures

Disease-free survival (DFS)

Secondary Outcome Measures

Circulating tumor DNA (ctDNA) response rate

ctDNA duration of response (DOR)

ctDNA time to response (TTR)

Incidence of adverse events (AEs)

Incidence of serious adverse events (SAEs)

Full Information

NCT ID

NCT03770299

First Posted

December 7, 2018

Last Updated

March 9, 2022

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03770299

Brief Title

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

Acronym

CheckMate 9TN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Business objectives have changed

Study Start Date

January 15, 2021 (Anticipated)

Primary Completion Date

March 14, 2023 (Anticipated)

Study Completion Date

March 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Nivolumab + SOC (chemotherapy in eligible participants or observation)

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

SOC (chemotherapy in eligible participants or observation)

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Intervention Description