Clinical Trial: NCT05955391
TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Shenzhen TargetRx Co., Ltd. |
| Information Provided By: | Shenzhen TargetRx Co., Ltd. |
| Last Update Posted: | 2025-05-18 |
Study Overview
Brief Summary
This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance.
Official Title
A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: TGRX-326
Other Study ID Numbers
- TGRX-326-2001-NSCLC-CN
Start Date (Actual)
2023-01-18
Primary Completion Date (Actual)
2024-12-29
Study Completion Date (Estimated)
2025-12-31
Enrollment (Actual)
164
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Shenzhen TargetRx Co., Ltd. |
| Information Provided By: | Shenzhen TargetRx Co., Ltd. |
| Last Update Posted: | 2025-05-18 |
Study Overview
Brief Summary
This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance.
Official Title
A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: TGRX-326
Other Study ID Numbers
- TGRX-326-2001-NSCLC-CN
Start Date (Actual)
2023-01-18
Primary Completion Date (Actual)
2024-12-29
Study Completion Date (Estimated)
2025-12-31
Enrollment (Actual)
164
Study Type
Interventional
Phase
Phase 2