ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-li
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) p
| Condition(s) | NSCLC (Advanced Non-small Cell Lung Cancer), EGFR Mutation Positive Advanced Non Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * ECOG performance status score of 0-1; * Histologically or cytologically confirmed stage IV primary non-small cell lung cancer; * EGFR-sensitive mutations (L858R, 19del); * Resistance to first-line treatment with third-generation EGFR-TKIs; * At least one measurable lesion; * Patients with brain metastases may be included, but they must be asymptomatic neurologically and have stable lesions without the need for systemic corticosteroid treatment; * Men and women of reproductive age agree to contraception during the trial (surgical sterilization or oral contraceptives/intrauterine device + condoms); * Life expectancy ≥ 3 months; * Within one week before enrollment, organ function levels must meet the following criteria: 1. Bone marrow function: Hemoglobin ≥ 80 g/L, white |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-01-15 |
| NCT ID | NCT06775743 |
| Official listing | https://clinicaltrials.gov/study/NCT06775743 |