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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770299
Recruitment Status : Withdrawn (Business objectives have changed)
First Posted : December 10, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Non-Small-Cell Lung Carcinoma Circulating Tumor DNA Biological: Nivolumab Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Other: Observation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : March 14, 2023
Estimated Study Completion Date : March 14, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A
Nivolumab + SOC (chemotherapy in eligible participants or observation)
Biological: Nivolumab
Specified dose on specified days

Drug: Vinorelbine
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Drug: Pemetrexed
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Drug: Paclitaxel
Specified dose on specified days

Other: Observation
Observation by the investigator

Active Comparator: Arm B
SOC (chemotherapy in eligible participants or observation)
Drug: Vinorelbine
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Drug: Pemetrexed
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Drug: Paclitaxel
Specified dose on specified days

Other: Observation
Observation by the investigator




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Circulating tumor DNA (ctDNA) response rate [ Time Frame: Approximately 36 months ]
  2. ctDNA duration of response (DOR) [ Time Frame: Approximately 36 months ]
  3. ctDNA time to response (TTR) [ Time Frame: Approximately 36 months ]
  4. Incidence of adverse events (AEs) [ Time Frame: Approximately 36 months ]
  5. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770299


Locations
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United States, Florida
Local Institution
Jacksonville, Florida, United States, 32224
United States, Kentucky
Local Institution
Lexington, Kentucky, United States, 40503-1489
Local Institution
Louisville, Kentucky, United States, 40241
United States, South Carolina
Local Institution
Charleston, South Carolina, United States, 29414
United States, Texas
Local Institution
Tyler, Texas, United States, 75701
Germany
Local Institution
Gauting, Germany, 82131
Local Institution
Grosshansdorf, Germany, 22927
Local Institution
Heidelberg, Germany, 69126
Switzerland
Local Institution
Lausanne, Switzerland, 1011
Local Institution
Zuerich, Switzerland, 8091
United Kingdom
Local Institution
Birmingham, United Kingdom, B9 5SS
Local Institution
London, United Kingdom, NW1 2BU
Local Institution
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03770299    
Other Study ID Numbers: CA209-9TN
2018-003719-23 ( EudraCT Number )
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm, Residual
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Gemcitabine
Paclitaxel
Vinorelbine
Docetaxel
Carboplatin
Nivolumab
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents