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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer ROS Translocated

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Chi Creteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CBNPC when they visit the respiratory ward

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival on Brigatinib in patients with ROS1 translocated CBNPCtransloated CBNPC	27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	27 months
Number of side effects associated with brigatinib	27 months
Types of side efects associated with brigatinib	27 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ACTUAL): October 17, 2021
• Study Completion (ACTUAL): October 17, 2021

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Brigatinib, lung cancer, ROS1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: BRIGAROS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No