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BRIGAROS: Retrospective, Observational, Multi-center Study Evaluating the Efficacy and Tolerance of Brigatinib in the Management of Rearranged CBNPC ROS1

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Completed
CT.gov ID
NCT04718012
Collaborator
(none)
22
Enrollment
1
Location
7
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ROS1 translocated Non small cell lung cancer (NSCLC) is a rare type of lung cancer with few datas. We collected datas concerning patients with ROS1 translocated NSCLC who received Brigatinib in the Compassionate Access after two others Tyrosine kinase Inhibitors

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Lung cancer is the most common cancer worldwide and the leading cause of cancer death in Western countries. Non-small cell lung cancer (NSCLC) is the most usual form (80-85%) of lung cancers. Unfortunately, at the time of diagnosis, most patients present with metastatic or advanced disease. Significant advances have been made in recent years on knowledge of oncogenesis of NSCLC in particularly the discovery of specific oncogenic drivers playing key role in oncogenic addiction responsible for the occurrence of NSCLC.

    ROS1 translocation is found in1 to 2 % of non small cell lung cancer. Due to this rare subtype of cancer, we have few datas. ROS1 translocation is found in a rather younger population, with a predominance of woman and non smoker. ROS1 translocation can be detected by immunohistochemistry and confirmed by FISH or RNA fusion technics.

    Crizotinib demonstrated his interest in the phase 1 trial PROFILE 1001 with an objective response rate of 72% tested on 52 patients, the median progression free survival was 19,3 months, overall survival of 51% at 48 months.

    Similar datas were found in different cohortes. A chinese study of 23 patients receiving crizotinib, the objective response rate was 56,5%, a median progression free survival of 14,5 months. A european retrospective cohorte EUROS1 of 30 patients receiving crizotinib found a progression free survival of 9,1 months, an objective response rate of 80% . A prospective european study EUCROSS included 34 patients with an objective response rate of 70% and a progression free survival of 20 months. The Acsé crizotinib cohorte included 37 patients ROS1 translocated, the objective response rate was lower at 47,2% in this study with heavily pretreated population.

    Ceritinib has been studied in a phase 2 study of 32 patients in whom 30 patients where treatment naifs of crizotinib, the objective response rate was 62%.

    Lorlatinib was studied in a phase1-2 trial, including 69 ROS1 patients, 21 were TKI naifs, 40 pretreated with crizotinib and 8 treated with one or two others TKI, with objective response rate of 62% in the naive population, and 41% on the entire cohorte.

    More recently, Entrectinib demonstrated his interest in a pooled study of 3 trial, 53 patients were ROS1 translocated and had an objective response rate of 77% with this new molecule.

    Few datas are available about brigatinib in ROS1 translocated patients, only three patients ROS1 were included in the brigatinib phase 1 trial. The aim of this study is to obtain more datas of efficacy, safety, among patients receiving Brigatinib with the compationnate access in France

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective, Observational, Multi-center Study Evaluating the Efficacy and Tolerance of Brigatinib in the Management of Rearranged CBNPC ROS1
    Actual Study Start Date :
    Mar 17, 2021
    Actual Primary Completion Date :
    Oct 17, 2021
    Actual Study Completion Date :
    Oct 17, 2021

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival on Brigatinib in patients with ROS1 translocated CBNPCtransloated CBNPC [27 months]

    Secondary Outcome Measures

    1. overall survival [27 months]

    2. Number of side effects associated with brigatinib [27 months]

    3. Types of side efects associated with brigatinib [27 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patient with CBNPC transloated ROS1

    • Treatment by Brigatinib as part of compassionate access in France

    • Patient > 18 years old

    Exclusion Criteria:
    • Refusal of the patient to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHI Créteil Créteil France 94000

    Sponsors and Collaborators

    • Centre Hospitalier Intercommunal Creteil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Intercommunal Creteil
    ClinicalTrials.gov Identifier:
    NCT04718012
    Other Study ID Numbers:
    • BRIGAROS
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Intercommunal Creteil
    Brigatinib, lung cancer, ROS1
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Nov 22, 2021