NCT06031558

Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SY-5007	a RET selective Inhibitor

Timeline

• Start date: 2023-06-20
• Primary completion: 2024-09-20
• Completion: 2026-06-20
• First posted: 2023-09-11
• Last updated: 2023-09-21

Locations

1 site across 1 country: China