drugset / Trial / NCT07818304

SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC

NCT07818304 ↗

Phase 2 Not yet recruiting 61 enrolled The First People's Hospital of Lianyungang
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

EvaluationDrugModalityDoseRoute
Subject Endostar Protein / enzyme biologic 210 mg Intravenous
Subject Envafolimab Monoclonal antibody 300 mg Subcutaneous