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A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia (CheckMate870)

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ClinicalTrials.gov Identifier: NCT03195491
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

Condition or disease Intervention/treatment Phase
Lung Cancer Non-Small Cell Lung Cancer Biological: Nivolumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : July 29, 2020
Estimated Study Completion Date : July 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Monotherapy
Nivolumab administered every two weeks
Biological: Nivolumab
Intravenous infusion administered over 30 minutes at 240 mg
Other Names:
  • Opdivo
  • BMS-936558




Primary Outcome Measures :
  1. Incidence of high grade treatment-related select adverse events in non-hepatitis B virus (HBV) infected participants [ Time Frame: Approximately 2 years ]
    Measured by number of incidences

  2. Severity of high grade treatment-related select adverse events in non-HBV infected participants [ Time Frame: Approximately 2 years ]
    Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)


Secondary Outcome Measures :
  1. Incidence of high grade treatment-related select adverse events in HBV infected participants [ Time Frame: Approximately 2 years ]
    Measured by number of incidences

  2. Severity of high grade treatment-related select adverse events in HBV infected participants [ Time Frame: Approximately 2 years ]
    Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)

  3. Laboratory test abnormalities [ Time Frame: Approximately 2 years ]
    Measured by laboratory test parameters

  4. Incidence of adverse events in all treated patients [ Time Frame: Approximately 2 years ]
    Measured by number of incidences

  5. Severity of adverse events in all treated patients [ Time Frame: Approximately 2 years ]
    Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)



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:

  • Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
  • 1 to 2 prior systemic therapies
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment

Exclusion Criteria:

  • Women with a positive pregnancy test at enrollment or prior to administration of study medication
  • Participants with active central nervous system metastases
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
  • Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
  • Participants with carcinomatous meningitis

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): NCT03195491


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 42 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03195491     History of Changes
Other Study ID Numbers: CA209-870
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs