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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
NSCLC (advanced Non-small Cell Lung Cancer)EGFR Mutation Positive Advanced Non Small Cell Lung Cancer
Interventions
DRUG

ORIENT-31 regimen

Sintilimab plus bevacizumab plus platinum-doublet chemotherapy

RADIATION

SBRT

"Based on the results of the response evaluation, personalized SBRT will be arranged after cycle 4:~A. Complete response, CR: continue with maintenance therapy of PD-1 antibody + pemetrexed + VEGF antibody until disease progression, intolerable toxic side effects, or up to two years.~B. Stable disease, SD/partial response, PR: if the residual lesions do not exceed three organs and five lesions, and if the investigator deems SBRT feasible, curative-dose stereotactic radiotherapy covering all residual lesions will be administered, with dosing based on the NRG-BR001 study.~C. If the residual lesions exceed three organs or five lesions, SBRT (24 Gy/3 Fx) targeting 1-3 selected tumor lesions will be performed, and then continue with maintenance therapy of PD-1 antibody + pemetrexed + VEGF antibody until disease progression.~D. Progressive disease, PD: subsequent treatment is conducted according to the standard guidelines."

All Listed Sponsors
lead

Fudan University

OTHER