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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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
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
No
Data Monitoring Committee
No
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
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Observation by the investigator
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Time Frame
Approximately 24 months
Secondary Outcome Measure Information:
Title
Circulating tumor DNA (ctDNA) response rate
Time Frame
Approximately 36 months
Title
ctDNA duration of response (DOR)
Time Frame
Approximately 36 months
Title
ctDNA time to response (TTR)
Time Frame
Approximately 36 months
Title
Incidence of adverse events (AEs)
Time Frame
Approximately 36 months
Title
Incidence of serious adverse events (SAEs)
Time Frame
Approximately 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
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