An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease (CheckMate 9TN)
March 9, 2022 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Status
Withdrawn
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
|
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Observation by the investigator
|
|
ACTIVE_COMPARATOR: Arm B
SOC (chemotherapy in eligible participants or observation)
|
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Observation by the investigator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disease-free survival (DFS)
Time Frame: Approximately 24 months
|
Approximately 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Circulating tumor DNA (ctDNA) response rate
Time Frame: Approximately 36 months
|
Approximately 36 months
|
|
ctDNA duration of response (DOR)
Time Frame: Approximately 36 months
|
Approximately 36 months
|
|
ctDNA time to response (TTR)
Time Frame: Approximately 36 months
|
Approximately 36 months
|
|
Incidence of adverse events (AEs)
Time Frame: Approximately 36 months
|
Approximately 36 months
|
|
Incidence of serious adverse events (SAEs)
Time Frame: Approximately 36 months
|
Approximately 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 15, 2021
Primary Completion (ANTICIPATED)
March 14, 2023
Study Completion (ANTICIPATED)
March 14, 2024
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 7, 2018
First Posted (ACTUAL)
December 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2022
Last Update Submitted That Met QC Criteria
March 9, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neoplastic Processes
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Neoplasm, Residual
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Folic Acid Antagonists
- Gemcitabine
- Docetaxel
- Carboplatin
- Paclitaxel
- Cisplatin
- Nivolumab
- Vinorelbine
- Pemetrexed
Other Study ID Numbers
- CA209-9TN
- 2018-003719-23 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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