Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564324
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Multicenter Open-label Study of Taletrectinib Versus a Standard of Care ROS1-Tyrosine Kinase Inhibitor Crizotinib in TKI-Naïve Patients With ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer TRUST-III
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a Phase 3 randomized open-label comparative multicenter international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity ie ROS1 and who have not previously received an ROS1-targeted TKI ie ROS1-TKI-naïve
Approximately 138 ROS-1 TKI- naïve ROS1NSCLC patients will be randomized in a 11 ration to one of 2 study arms
Arm A Taletrectinib monotherapy at 600 mg once daily QD continuously
Arm B Crizotinib monotherapy at 250 mg twice daily BID continuously Each cycle duration will be 28 days
Participants will be stratified by the presence of intracranial metastases at baseline Yes versus No and prior chemotherapy use for locally advanced or metastatic disease Yes versus No For the purposes of stratification prior chemotherapy is defined as completion of 1 cycle of chemotherapy in the locally advanced or metastatic setting Participants will be treated until they experience progressive disease PD assessed by the BIRC intolerable toxicity or another discontinuation criterion is met Crossover from control group crizotinib to taletrectinib is also permitted at the Investigators discretion with the Sponsors approval for qualifying participants who have experienced objective progression confirmed by the BIRC
Approximately 138 ROS-1 TKI- naïve ROS1NSCLC patients will be randomized in a 11 ration to one of 2 study arms
Arm A Taletrectinib monotherapy at 600 mg once daily QD continuously
Arm B Crizotinib monotherapy at 250 mg twice daily BID continuously Each cycle duration will be 28 days
Participants will be stratified by the presence of intracranial metastases at baseline Yes versus No and prior chemotherapy use for locally advanced or metastatic disease Yes versus No For the purposes of stratification prior chemotherapy is defined as completion of 1 cycle of chemotherapy in the locally advanced or metastatic setting Participants will be treated until they experience progressive disease PD assessed by the BIRC intolerable toxicity or another discontinuation criterion is met Crossover from control group crizotinib to taletrectinib is also permitted at the Investigators discretion with the Sponsors approval for qualifying participants who have experienced objective progression confirmed by the BIRC
Detailed Description:
None
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