Clinical Trial: NCT06031558
Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Shouyao Holdings (Beijing) Co. LTD |
| Information Provided By: | Shouyao Holdings (Beijing) Co. LTD |
| Last Update Posted: | 2026-06-16 |
Study Overview
Brief 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.
Official Title
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.
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: SY-5007
Other Study ID Numbers
- SY-5007-III-01
Start Date (Actual)
2023-10-31
Primary Completion Date (Actual)
2025-04-10
Study Completion Date (Estimated)
2026-06-20
Enrollment (Estimated)
120
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Shouyao Holdings (Beijing) Co. LTD |
| Information Provided By: | Shouyao Holdings (Beijing) Co. LTD |
| Last Update Posted: | 2026-06-16 |
Study Overview
Brief 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.
Official Title
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.
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: SY-5007
Other Study ID Numbers
- SY-5007-III-01
Start Date (Actual)
2023-10-31
Primary Completion Date (Actual)
2025-04-10
Study Completion Date (Estimated)
2026-06-20
Enrollment (Estimated)
120
Study Type
Interventional
Phase
Phase 3