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A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC - Trial NCT06254599

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.

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NCT06254599
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06254599
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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

Study Focus

SY-3505 Capsules

Interventional

drug

Sponsor & Location

Shouyao Holdings (Beijing) Co. LTD

Beijing, China

Timeline & Enrollment

Phase 3

May 01, 2024

May 01, 2027

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 lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06254599

Non-Device Trial