NCT05869162

Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI

A Phase II, Open-Label, Single-Arm, Multicenter Study of Efficacy and Safety of SY-3505 in Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer Who Have Progressed On or Are Intolerant to Second-Generation ALK TKI

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multicenter, phase II study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK tyrosine kinase inhibitor (TKI).

Detailed description

SY-3505 is a potent, brain-penetrant, third-generation ALK tyrosine kinase inhibitor (TKI) with preclinical activity against both wild-type and most known resistance mutations of ALK occurring in first-generation and second-generation ALK TKI-resistant patients. In this phase 2 study, patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK TKI will be treated with SY-3505 capsules at 600 mg once daily (QD) orally until disease progression, refusal or unacceptable toxicity. Cycles of treatment are every 21 days with continuous dosing of SY-3505. During the study, patients will be followed-up for safety and efficacy evaluation at study protocol defined time points.

Conditions

• Non-small-cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	SY-3505	A Third-generation ALK TKI

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-06-10
• Completion: 2025-06-10
• First posted: 2023-05-22
• Last updated: 2023-08-25

Locations

1 site across 1 country: China