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Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC - Trial NCT06031558

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.

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NCT06031558
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06031558
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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.

Study Focus

SY-5007

Interventional

drug

Sponsor & Location

Shouyao Holdings (Beijing) Co. LTD

Shanghai, China

Timeline & Enrollment

Phase 3

Jun 20, 2023

Jun 20, 2026

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 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

NCT06031558

Non-Device Trial