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NCT06031558Recruiting

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.
Shouyao Holdings (Beijing) Co. LTDPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Non-Small Cell Lung Cancer
Drug/Device/Intervention
SY-5007
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shouyao Holdings (Beijing) Co. LTD
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 3
Start date
Jun 20, 2023
End date
Jun 20, 2026
Enrollment
120 participants
Primary outcome

Assessment of ORR by independent review committee (IRC).

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.

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
NCT06031558
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06031558 through Pure Global AI's free database. This Phase 3 trial is sponsored by Shouyao Holdings (Beijing) Co. LTD and is currently Recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 120 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.