drugset / Trial / NCT07818304
SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene alterations and with PD-L1 TPS ≥ 1%. A total of 61 eligible participants will receive combination treatment of stereotactic radiotherapy, envafolimab and endostar. Tumor response will be evaluated every 6 weeks according to RECIST v1.1, and treatment-related adverse events will be monitored based on NCI-CTCAE v5.0. The treatment will continue until disease progression, patient withdrawal, loss of follow-up or death.
Timeline
- Start
- 2026-10
- Primary completion
- 2028-04
- Completion
- 2028-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Endostar | Protein / enzyme biologic | 210 mg | Intravenous |
| Subject | Envafolimab | Monoclonal antibody | 300 mg | Subcutaneous |