Study Stopped
The standard of care for the patient population changed and we were unable to accrue any longer.
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
FRACTION-Lung
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)
1 other identifier
interventional
295
7 countries
49
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Typical duration for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 25, 2016
CompletedStudy Start
First participant enrolled
May 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2020
CompletedResults Posted
Study results publicly available
March 22, 2021
CompletedMarch 22, 2021
February 1, 2021
3.7 years
April 21, 2016
January 27, 2021
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
From first dose to 2 years following last dose (up to 30 months)
Duration of Response (DOR)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
From first dose to 2 years following last dose (up to 30 months)
Progression Free Survival Rate (PFSR) at 24 Weeks
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
From first dose to 24 weeks after first dose
Secondary Outcomes (6)
Percentage of Participants Experiencing Adverse Events (AEs)
From first dose to 100 days following last dose
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
From first dose to 100 days following last dose
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
From first dose to 100 days following last dose
Percentage of Participants Experiencing Death
From first dose to up to 45 months following first dose
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
From first dose to 100 days following last dose (approximately 9 months)
- +1 more secondary outcomes
Study Arms (5)
Nivolumab
ACTIVE COMPARATORNivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator
Nivolumab & Dasatinib
EXPERIMENTALNivolumab in combination with Dasatinib
Nivolumab & Relatlimab
EXPERIMENTALNivolumab in combination with Relatlimab
Nivolumab & Ipilimumab
EXPERIMENTALNivolumab in combination with Ipilimumab
Nivolumab & BMS-986205
EXPERIMENTALNivolumab in combination with BMS- 986205
Interventions
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of Southern California (USC)
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Californa, Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
University of California San Diego
San Diego, California, 92122, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Yale Cancer Center
New Haven, Connecticut, 06511, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University, The Center for Advanced Medicine
St Louis, Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89119, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Univ of NC Shool of Medicine
Chapel Hill, North Carolina, 27514, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Northwest Cancer Specialists
Portland, Oregon, 97225, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15217, United States
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, 38138, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Sammons Cancer Center (Uso)
Dallas, Texas, 75246, United States
Texas Oncology, P.A.
Fort Worth, Texas, 76104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Us Oncology
Tyler, Texas, 75702, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Local Institution
Clayton, Victoria, Australia
Local Institution
Salzburg, 5020, Austria
Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
University Of Ottawa - The Ottawa Hospital Cancer centre
Ottawa, Ontario, K1H 8L6, Canada
Local Institution
Edmonton, T6G 1Z2, Canada
Local Institution
Paris, 75005, France
Local Institution
Toulouse, 31059, France
Local Institution
Villejuif, 94805, France
Local Institution
Milan, 20141, Italy
Local Institution
Milan, 20132, Italy
Local Institution
Rozzano, 20089, Italy
Local Institution
Madrid, 28041, Spain
Local Institution
Madrid, 28050, Spain
Local Institution
Pamplona, 31008, Spain
Local Institution
Lausanne, CH-1011, Switzerland
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early by sponsor for reasons unrelated to safety.
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2016
First Posted
April 25, 2016
Study Start
May 9, 2016
Primary Completion
January 29, 2020
Study Completion
January 29, 2020
Last Updated
March 22, 2021
Results First Posted
March 22, 2021
Record last verified: 2021-02