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

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: NCT03195491
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : August 28, 2019
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

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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 13, 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

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.


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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


Locations
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United States, Texas
Local Institution
Dallas, Texas, United States, 75208
China, Beijing
Local Institution
Beijing, Beijing, China, 100001
Local Institution
Beijing, Beijing, China, 100021
Local Institution
Beijing, Beijing, China, 100142
Local Institution
Beijing, Beijing, China, 100730
Local Institution
Beijing, Beijing, China, 101149
China, Fujian
Local Institution
Fuzhou, Fujian, China, 350014
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510080
China, Hebei
Local Institution
Beijing, Hebei, China, 100031
China, Heilongjiang
Local Institution
Harbin, Heilongjiang, China, 150081
China, Henan
Local Institution
Zhengzhou, Henan, China, 450008
China, Hubei
Local Institution
Wuhan, Hubei, China, 430022
China, Hunan
Local Institution
Changsha, Hunan, China, 410013
Local Institution
Zhengzhou, Hunan, China, 450004
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210000
Local Institution
Nanjing, Jiangsu, China, 210002
China, Jilin
Local Institution
Changchun, Jilin, China, 130012
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 10041
China, Shan3xi
Local Institution
Xi'an, Shan3xi, China, 710038
China, Shandong
Local Institution
Jinan City, Shandong, China, 250031
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200020
Local Institution
Shanghai, Shanghai, China, 200032
Local Institution
Shanghai, Shanghai, China, 200433
China, Sichuan
Local Institution
Chengdu, Sichuan, China, 610041
China, Tianjin
Local Institution
Tianjin, Tianjin, China, 300222
Local Institution
Tianjin, Tianjin, China, 410013
China, Xinjiang
Local Institution
Urumqi, Xinjiang, China, 830011
Local Institution
Wulumuqi, Xinjiang, China, 830011
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310000
Local Institution
Hangzhou, Zhejiang, China, 310003
Local Institution
Hangzhou, Zhejiang, China, 310022
China
Local Institution
Guangzhou, China
Local Institution
Shanghai, China, 200030
Local Institution
Shanghai, China, 200032
Local Institution
Shenyang, China, 110042
Thailand
Local Institution
Bangkok, Thailand, 10700
Local Institution
Khon Kaen, Thailand, 40002
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: NCT03195491    
Other Study ID Numbers: CA209-870
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Antineoplastic Agents