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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02750514
Registration number
NCT02750514
Ethics application status
Date submitted
21/04/2016
Date registered
25/04/2016
Date last updated
22/03/2021
Titles & IDs
Public title
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
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Scientific 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)
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Secondary ID [1]
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CA018-001
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Universal Trial Number (UTN)
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Trial acronym
FRACTION-Lung
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Dasatinib
Other interventions - Relatlimab
Other interventions - Ipilimumab
Treatment: Drugs - BMS-986205
Active Comparator: Nivolumab - Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator
Experimental: Nivolumab & Dasatinib - Nivolumab in combination with Dasatinib
Experimental: Nivolumab & Relatlimab - Nivolumab in combination with Relatlimab
Experimental: Nivolumab & Ipilimumab - Nivolumab in combination with Ipilimumab
Experimental: Nivolumab & BMS-986205 - Nivolumab in combination with BMS- 986205
Other interventions: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Treatment: Drugs: Dasatinib
Other interventions: Relatlimab
Other interventions: Ipilimumab
Treatment: Drugs: BMS-986205
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose to 2 years following last dose (up to 30 months)
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Primary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose to 2 years following last dose (up to 30 months)
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Primary outcome [3]
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Progression Free Survival Rate (PFSR) at 24 Weeks
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose to 24 weeks after first dose
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Secondary outcome [1]
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Percentage of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
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Timepoint [1]
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From first dose to 100 days following last dose
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Secondary outcome [2]
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Percentage of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [2]
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This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
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Timepoint [2]
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From first dose to 100 days following last dose
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Secondary outcome [3]
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Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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Assessment method [3]
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This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
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Timepoint [3]
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From first dose to 100 days following last dose
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Secondary outcome [4]
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Percentage of Participants Experiencing Death
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Assessment method [4]
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This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
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Timepoint [4]
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From first dose to up to 45 months following first dose
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Secondary outcome [5]
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Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
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Assessment method [5]
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The following measurements will be considered laboratory abnormalities for hepatic tests:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
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Timepoint [5]
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From first dose to 100 days following last dose (approximately 9 months)
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Secondary outcome [6]
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Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
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Assessment method [6]
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The following measurements will be considered laboratory abnormalities for thyroid tests:
TSH value > ULN and
With baseline TSH value = ULN
At least one T3/T4 test value < LLN
Low TSH < LLN and
With baseline TSH value = LLN
At least one T3/T4 test value > ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
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Timepoint [6]
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From first dose to 100 days following last dose (approximately 9 months)
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/01/2020
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Sample size
Target
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Accrual to date
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Final
295
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - Clayton
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Recruitment postcode(s) [1]
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- Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Kansas
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Country [5]
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United States of America
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State/province [5]
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Maryland
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Country [6]
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Missouri
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Country [9]
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United States of America
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State/province [9]
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Nevada
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Country [10]
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United States of America
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State/province [10]
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New York
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Country [11]
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United States of America
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State/province [11]
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North Carolina
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United States of America
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State/province [12]
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Ohio
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United States of America
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State/province [13]
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Oregon
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Pennsylvania
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United States of America
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Tennessee
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Texas
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Utah
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Country [18]
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Virginia
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Country [19]
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United States of America
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Washington
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Country [20]
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Austria
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State/province [20]
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Salzburg
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Country [21]
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Canada
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State/province [21]
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Ontario
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Country [22]
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Canada
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Edmonton
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France
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Paris
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France
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Toulouse
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France
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Villejuif Cedex
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Italy
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Milano
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Italy
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Milan
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Italy
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Rozzano
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Spain
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State/province [29]
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Madrid
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Country [30]
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Spain
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State/province [30]
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Pamplona
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Country [31]
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Switzerland
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State/province [31]
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Lausanne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02750514
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02750514
Download to PDF