Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552234
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Phase II Efficacy Study of Repotrectinib in Frail andor Elderly Patients With ROS1-rearranged Advanced NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-label Phase II Efficacy Study of Repotrectinib in Frail PS 2 andor Elderly Patients With ROS1-rearranged Advanced NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPOROS
Brief Summary:
ROS1 rearrangements are rare accounting for only 1-2 of NSCLC cases but have been associated with response to ROS1 inhibitors such as crizotinib and entrectinib However many patients develop resistance to the tyrosine-kinase inhibitors TKIs creating a need for new treatments
Repotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies Drilon 2018 Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements TRIDENT-1 study but there are limited evidence in frail populations such as poor performance status patients andor elderly patients who are classically excluded from clinical trials or underrepresented
The present study aims to assess the activity and tolerability of repotrectinib in frail PS 2 andor elderly patients with ROS1-rearranged advanced NSCLC
Repotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies Drilon 2018 Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements TRIDENT-1 study but there are limited evidence in frail populations such as poor performance status patients andor elderly patients who are classically excluded from clinical trials or underrepresented
The present study aims to assess the activity and tolerability of repotrectinib in frail PS 2 andor elderly patients with ROS1-rearranged advanced NSCLC
Detailed Description:
This is a national multicenter phase II prospective open label non-randomized interventional study
Frail PS2 andor elderly patients 70 years with histologicallycytologically proven stage IV or stage III non-eligible to local treatment NSCLC harboring an ROS1 gene rearrangement treated by Repotrectinib 160 mg twice a day BID until progression or unacceptable toxicity in first or any line
Frail PS2 andor elderly patients 70 years with histologicallycytologically proven stage IV or stage III non-eligible to local treatment NSCLC harboring an ROS1 gene rearrangement treated by Repotrectinib 160 mg twice a day BID until progression or unacceptable toxicity in first or any line
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None