Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterat
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely
| Condition(s) | NSCLC |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors. |
| Who can participate | Inclusion Criteria: * The subjects will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures; * Male and female, ≥18 years old; * Primary non-squamous NSCLC confirmed histologically by the central laboratory; * The subject was clinically confirmed as stage IA2-IB by imaging with tumor lesion size \> 2 cm; * As confirmed by the central laboratory, the tumor contains no common EGFR mutations and ALK fusion variants; * The primary NSCLC must be completely resected by surgery, and all lesions must be removed at the end of the surgery.All surgical margins must be negative. Lobectomy can be done with open surgery or thoracoscopic (VATS); * Central laboratory pathology confirmed solid and/or micropapillary component ≥10%, and/or ST |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Tianjin, Tianjin Municipality, China |
| Start date | 2024-03-20 |
| NCT ID | NCT06221670 |
| Official listing | https://clinicaltrials.gov/study/NCT06221670 |