drugset / Trial / NCT06775743

ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs

NCT06775743 ↗

Phase 2 Recruiting 53 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this prospective study is to explore the safety and preliminary efficacy of stereotactic body radiotherapy (SBRT) combined with ORIENT-31 regimen (Sintilimab plus bevacizumab plus platinum-doublet chemotherapy) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients who failed first-line third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. Participants will first receive the standard four-drug combination therapy: PD-1 antibody + vascular endothelial growth factor (VEGF) antibody + platinum + pemetrexed. The efficacy will be evaluated every two courses. According to the efficacy evaluation results, personalized SBRT was be administered.

Timeline

Start
2025-01-15
Primary completion
2026-12-31
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — —
Subject Pemetrexed Small molecule — —
Subject Sintilimab Monoclonal antibody — —