RecruitingPhase 3NCT06031558

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.


Sponsor

Shouyao Holdings (Beijing) Co. LTD

Enrollment

120 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called SY-5007 for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called a RET fusion — a mutation that drives cancer growth. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic NSCLC confirmed by biopsy - Your tumor has a RET fusion gene change (confirmed by genetic test) - You have not received any prior treatment for advanced/metastatic NSCLC - You have at least one measurable tumor lesion - You are in reasonably good physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to the brain and is untreated - You have an active autoimmune disease requiring ongoing treatment - You have significant heart, liver, or kidney problems - You have had a prior organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSY-5007

a RET selective Inhibitor


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06031558


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