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

Lung Cancer Clinical Trial

— CheckMate870  

Official title:

An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195491
• Other study ID #: CA209-870
• Status: Completed
• Phase: Phase 3
• Start date: December 25, 2017
• Est. completion date: June 8, 2021

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Biological:
• Nivolumab
Intravenous infusion administered over 30 minutes at 240 mg

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Hebei
China	Local Institution	Changchun	Jilin
China	Local Institution	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Fuzhou	Fujian
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Harbin	Heilongjiang
China	Local Institution	Jinan	Shandong
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai
China	Local Institution	Shanghai
China	Local Institution	Shenyang
China	Local Institution	Tianjin	Tianjin
China	Local Institution	Urumqi	Xinjiang
China	Local Institution	Wuhan	Hubei
China	Local Institution	Xi'an	Shan3xi
China	Local Institution	Zhengzhou	Henan
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of high grade treatment-related select adverse events in non-hepatitis B virus (HBV) infected participants	Measured by number of incidences	Approximately 2 years
Primary	Severity of high grade treatment-related select adverse events in non-HBV infected participants	Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)	Approximately 2 years
Secondary	Incidence of high grade treatment-related select adverse events in HBV infected participants	Measured by number of incidences	Approximately 2 years
Secondary	Severity of high grade treatment-related select adverse events in HBV infected participants	Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)	Approximately 2 years
Secondary	Laboratory test abnormalities	Measured by laboratory test parameters	Approximately 2 years
Secondary	Incidence of adverse events in all treated patients	Measured by number of incidences	Approximately 2 years
Secondary	Severity of adverse events in all treated patients	Measured by National Cancer Institute- Common Terminology Criteria for Adverse Events version 4 (NCI-CTCAE v4)	Approximately 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls