NCT06254599

A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.

Detailed description

This is a multicenter, randomized controlled phase III trial to evaluate the efficacy and safety of SY-3505 capsule vs. crizotinib capsule in treatment-naive patients with ALK-positive NSCLC. Participants will be randomized in a 2:1 ratio to receive SY-3505, 600 milligrams (mg) orally once daily (QD), or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SY-3505 Capsules	A third-generation ALK tyrosine kinase inhibitor
DRUG	Crizotinib Capsules	An oral ALK tyrosine kinase inhibitor

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

1 site across 1 country: China