Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770299
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : September 25, 2019
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : June 15, 2020
Estimated Primary Completion Date : March 14, 2023
Estimated Study Completion Date : March 14, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Layout table for location information
United States, Florida
Local Institution Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Site 0015         
United States, Kentucky
Local Institution Not yet recruiting
Lexington, Kentucky, United States, 40503-1489
Contact: Site 0014         
Local Institution Not yet recruiting
Louisville, Kentucky, United States, 40241
Contact: Site 0016         
United States, South Carolina
Local Institution Not yet recruiting
Charleston, South Carolina, United States, 29414
Contact: Site 0010         
United States, Texas
Local Institution Not yet recruiting
Tyler, Texas, United States, 75701
Contact: Site 0013         
Germany
Local Institution Not yet recruiting
Gauting, Germany, 82131
Contact: Site 0005         
Local Institution Not yet recruiting
Grosshansdorf, Germany, 22927
Contact: Site 0006         
Local Institution Not yet recruiting
Heidelberg, Germany, 69126
Contact: Site 0007         
Switzerland
Local Institution Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Site 0009         
Local Institution Not yet recruiting
Zuerich, Switzerland, 8091
Contact: Site 0008         
United Kingdom
Local Institution Not yet recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Site 0004         
Local Institution Not yet recruiting
London, United Kingdom, NW1 2BU
Contact: Site 0001         
Local Institution Not yet recruiting
Manchester, United Kingdom, M23 9LT
Contact: Site 0003         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03770299     History of Changes
Other Study ID Numbers: CA209-9TN
2018-003719-23 ( EudraCT Number )
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Vinorelbine
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
Enzyme Inhibitors
Immunosuppressive Agents