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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 | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

NCT03770299•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

January 15, 2021

Primary Completion Date

March 14, 2023

Completion Date

March 14, 2024

Last Updated

March 24, 2022

Conditions

Non-Small Cell Lung CancerNon-Small-Cell Lung CarcinomaCirculating Tumor DNA

Interventions

Nivolumab

BIOLOGICAL

Vinorelbine

DRUG

Gemcitabine

DRUG

Docetaxel

DRUG

Pemetrexed

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Observation

OTHER

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)