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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

NCT ID: NCT03770299

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2024-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Nivolumab + SOC (chemotherapy in eligible participants or observation)

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Vinorelbine

Intervention Type DRUG

Specified dose on specified days

Gemcitabine

Intervention Type DRUG

Specified dose on specified days

Docetaxel

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Observation

Intervention Type OTHER

Observation by the investigator

Arm B

SOC (chemotherapy in eligible participants or observation)

Group Type ACTIVE_COMPARATOR

Vinorelbine

Intervention Type DRUG

Specified dose on specified days

Gemcitabine

Intervention Type DRUG

Specified dose on specified days

Docetaxel

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Observation

Intervention Type OTHER

Observation by the investigator

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Vinorelbine

Specified dose on specified days

Intervention Type DRUG

Gemcitabine

Specified dose on specified days

Intervention Type DRUG

Docetaxel

Specified dose on specified days

Intervention Type DRUG

Pemetrexed

Specified dose on specified days

Intervention Type DRUG

Cisplatin

Specified dose on specified days

Intervention Type DRUG

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Paclitaxel

Specified dose on specified days

Intervention Type DRUG

Observation

Observation by the investigator

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)


* 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

* 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


* Must have no evidence of metastatic disease after surgery
* Received a live/attenuated vaccine within 30 days of first treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2018-003719-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-9TN

Identifier Type: -

Identifier Source: org_study_id

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