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An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02750514
Recruitment Status : Terminated (The standard of care for the patient population changed and we were unable to accrue any longer.)
First Posted : April 25, 2016
Results First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: Nivolumab Drug: Dasatinib Biological: Relatlimab Biological: Ipilimumab Drug: BMS-986205 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : January 29, 2020
Actual Study Completion Date : January 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nivolumab
Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO

Experimental: Nivolumab & Dasatinib
Nivolumab in combination with Dasatinib
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO

Drug: Dasatinib
Other Names:
  • BMS-354825
  • SPRYCEL

Experimental: Nivolumab & Relatlimab
Nivolumab in combination with Relatlimab
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO

Biological: Relatlimab
Other Name: BMS-986016

Experimental: Nivolumab & Ipilimumab
Nivolumab in combination with Ipilimumab
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO

Biological: Ipilimumab
Other Names:
  • BMS-734016
  • Yervoy

Experimental: Nivolumab & BMS-986205
Nivolumab in combination with BMS- 986205
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO

Drug: BMS-986205
Specified dose on specified days




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From first dose to 2 years following last dose (up to 30 months) ]

    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.


  2. Duration of Response (DOR) [ Time Frame: From first dose to 2 years following last dose (up to 30 months) ]

    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.


  3. Progression Free Survival Rate (PFSR) at 24 Weeks [ Time Frame: From first dose to 24 weeks after first dose ]

    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.



Secondary Outcome Measures :
  1. Percentage of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose to 100 days following last dose ]
    This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame

  2. Percentage of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: From first dose to 100 days following last dose ]
    This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame

  3. Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [ Time Frame: From first dose to 100 days following last dose ]
    This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame

  4. Percentage of Participants Experiencing Death [ Time Frame: From first dose to up to 45 months following first dose ]
    This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame

  5. Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests [ Time Frame: From first dose to 100 days following last dose (approximately 9 months) ]

    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

  6. Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests [ Time Frame: From first dose to 100 days following last dose (approximately 9 months) ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750514


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] November 1, 2017
Study Protocol  [PDF] April 22, 2019

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02750514    
Other Study ID Numbers: CA018-001
First Posted: April 25, 2016    Key Record Dates
Results First Posted: March 22, 2021
Last Update Posted: March 22, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Ipilimumab
Dasatinib
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors