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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Secondary ID [1] 0 0
CA018-001
Universal Trial Number (UTN)
Trial acronym
FRACTION-Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
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


Treatment: Other: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Treatment: Drugs: BMS-986205
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From first dose to 2 years following last dose (up to 30 months)
Primary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
From first dose to 2 years following last dose (up to 30 months)
Primary outcome [3] 0 0
Progression Free Survival Rate (PFSR) at 24 Weeks
Timepoint [3] 0 0
From first dose to 24 weeks after first dose
Secondary outcome [1] 0 0
Percentage of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
From first dose to 100 days following last dose
Secondary outcome [2] 0 0
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose to 100 days following last dose
Secondary outcome [3] 0 0
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Timepoint [3] 0 0
From first dose to 100 days following last dose
Secondary outcome [4] 0 0
Percentage of Participants Experiencing Death
Timepoint [4] 0 0
From first dose to up to 45 months following first dose
Secondary outcome [5] 0 0
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
Timepoint [5] 0 0
From first dose to 100 days following last dose (approximately 9 months)
Secondary outcome [6] 0 0
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
Timepoint [6] 0 0
From first dose to 100 days following last dose (approximately 9 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2020
Sample size
Target
Accrual to date
Final
295
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Clayton
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Austria
State/province [20] 0 0
Salzburg
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Edmonton
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Villejuif Cedex
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Milan
Country [28] 0 0
Italy
State/province [28] 0 0
Rozzano
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Pamplona
Country [31] 0 0
Switzerland
State/province [31] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02750514
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02750514