NCT06775743 ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs
| NCT ID | NCT06775743 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | NSCLC (Advanced Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 blood cell count ≥ 4.0 × 10\^9/L or neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L; 2. Liver: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, and when serum total
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