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 (Jun 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
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
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.
Frequently asked questions
Is NCT06775743 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received third-generation EGFR TKI.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualifyRelated pages