Clinical trial NCT03195491: A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia
Official title: An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events
timeFrame: From first dose up to 100 days post dose, up to approximately 36 months
Secondary outcomes:
measure: Number of HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events
timeFrame: From first dose up to 100 days post dose, up to approximately 36 months
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose up to 100 days post dose, up to approximately 36 months
measure: Overall Survival (OS)
timeFrame: From the first dose up to the date of death. Participants without documentation of death will be censored on the late date known to be alive, up to approximately 32 months
measure: Progression-Free Survival (PFS)
timeFrame: From the first dose up to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, up to approximately 30 months
measure: Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose up to 100 days post last dose, up to approximately 36 months
measure: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days post last dose, up to 36 months
measure: Objective Response Rate
timeFrame: From the first dose date up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. Up to approximately 36 months
measure: Duration of Tumor Response
timeFrame: From the date of first confirmed response to the date of the first documented tumor progression, up to approximately 30 months
measure: Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From randomization to 100 days post last dose, up to 36 months
measure: Time to Treatment Failure (TTF)
timeFrame: From treatment assignment to disease progression, death or last dose date, up to approximately 16 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Fuzhou
country: China
facility: Local Institution
state: Fujian
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Beijing
country: China
facility: Local Institution
state: Hebei
city: Harbin
country: China
facility: Local Institution
state: Heilongjiang
city: Zhengzhou
country: China
facility: Local Institution
state: Henan
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Changsha
country: China
facility: Local Institution - 0017
state: Hunan
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Xi'an
country: China
facility: Local Institution
state: Shan3xi
city: Jinan
country: China
facility: Local Institution
state: Shandong
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Tianjin
country: China
facility: Local Institution
state: Tianjin
city: Urumqi
country: China
facility: Local Institution
state: Xinjiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Guangzhou
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Shenyang
country: China
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Khon Kaen
country: Thailand
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: