Clinical Trial: NCT05168566
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Status:
RECRUITINGPhase:
Phase 2| Lead Sponsor: | Teligene US |
| Information Provided By: | Teligene US |
| Last Update Posted: | 2026-10-21 |
Study Overview
Brief Summary
This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Official Title
A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Sutetinib Maleate Capsule
Other Study ID Numbers
- SZCT-2020-06
Start Date (Actual)
2022-09-01
Primary Completion Date (Estimated)
2027-12
Study Completion Date (Estimated)
2028-12
Enrollment (Estimated)
128
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Teligene US |
| Information Provided By: | Teligene US |
| Last Update Posted: | 2026-10-21 |
Study Overview
Brief Summary
This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Official Title
A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Sutetinib Maleate Capsule
Other Study ID Numbers
- SZCT-2020-06
Start Date (Actual)
2022-09-01
Primary Completion Date (Estimated)
2027-12
Study Completion Date (Estimated)
2028-12
Enrollment (Estimated)
128
Study Type
Interventional
Phase
Phase 2