OncoMatch/Clinical Trials/NCT06775743
ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs
Is NCT06775743 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ORIENT-31 regimen for nsclc (advanced non-small cell lung cancer).
Treatment: ORIENT-31 regimen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: third-generation EGFR TKI — first-line
Resistance to first-line treatment with third-generation EGFR-TKIs
Lab requirements
Blood counts
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
Kidney function
serum creatinine level < 1.5 times the upper limit of normal or creatinine clearance rate ≥ 50 ml/min, blood urea nitrogen ≤ 200 mg/l; serum albumin ≥ 30 g/l
Liver function
serum total bilirubin level ≤ 1.5 times the upper limit of normal, and when serum total bilirubin level > 1.5 times the upper limit of normal, direct bilirubin level must be ≤ the upper limit of normal, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 times the upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify