NCT06254599Not yet recruiting

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

Name: Clinical Trial NCT06254599
Creator: Shouyao Holdings (Beijing) Co. LTD
Keywords: Non-small Cell Lung Cancer, SY-3505 Capsules, Phase 3, drug, clinical trial, China

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

Shouyao Holdings (Beijing) Co. LTDPhase 3ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Non-small Cell Lung Cancer
Drug/Device/Intervention: SY-3505 Capsules
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Shouyao Holdings (Beijing) Co. LTD
Location: Beijing, China

Timeline & enrollment

Phase: Phase 3
Start date: May 01, 2024
End date: May 01, 2027
Enrollment: 255 participants

Primary outcome

Progression-free survival (PFS) assessed by independent radiology review (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria.

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.

ICD-10 classifications

Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06254599
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06254599 through Pure Global AI's free database. This Phase 3 trial is sponsored by Shouyao Holdings (Beijing) Co. LTD and is currently Not yet recruiting. The study focuses on Non-small Cell Lung Cancer. Target enrollment is 255 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.