Clinical trial NCT02750514: An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Advanced Non Small Cell Lung Cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
* Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
* Must have at least 1 lesion with measurable disease

Exclusion Criteria:

* Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
* Subjects who need daily oxygen therapy
* People with autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose to 2 years following last dose (up to 30 months)
measure: Duration of Response (DOR)
timeFrame: From first dose to 2 years following last dose (up to 30 months)
measure: Progression Free Survival Rate (PFSR) at 24 Weeks
timeFrame: From first dose to 24 weeks after first dose
Secondary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose to 100 days following last dose
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days following last dose
measure: Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 100 days following last dose
measure: Percentage of Participants Experiencing Death
timeFrame: From first dose to up to 45 months following first dose
measure: Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
timeFrame: From first dose to 100 days following last dose (approximately 9 months)
measure: Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
timeFrame: From first dose to 100 days following last dose (approximately 9 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California (USC)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Californa, Los Angeles (UCLA)
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber/Harvard Cancer Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University, The Center for Advanced Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: Univ of NC Shool of Medicine
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Sammons Cancer Center (Uso)
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Us Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: University of Washington-Seattle Cancer Care Alliance
state: Washington
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
city: Salzburg
country: Austria
facility: Local Institution
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: University Of Ottawa - The Ottawa Hospital Cancer centre
state: Ontario
city: Edmonton
country: Canada
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution
city: Rozzano
country: Italy
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Pamplona
country: Spain
facility: Local Institution
city: Lausanne
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: