Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04718012 |
| Other study ID # |
BRIGAROS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 17, 2021 |
| Est. completion date |
October 17, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Centre Hospitalier Intercommunal Creteil |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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
