Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06031558
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-08-31
Brief Title:
Phase III Study of SY-5007 a RET Inhibitor in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
Sponsor:
Shouyao Holdings Beijing Co LTD
Organization:
Shouyao Holdings Beijing Co LTD
Study Overview
Official Title:
A Phase III Open-Label Single-arm Multicenter Study to Evaluate the Efficacy and Safety of SY-5007 a RET Inhibitor in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III open-label single-arm multicenter study designed to evaluate the anti-tumor activity and safety of SY-5007 administered orally to participants with locally advanced or metastatic RET-positive NSCLC
Detailed Description:
This study will enroll patients with locally advanced or metastatic RET-positive NSCLC SY-5007 will be administered orally 160 mg twice daily in 28-day cycle continuously until disease progression death unacceptable toxicity withdrawal of consent or protocol-specified parameters This study is designed to evaluate the anti-tumor activity over response rate ORR disease control rate DCR duration of response DOR progression free survival PFS and overall survival OS and safety of SY-5007 in patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None