Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC
A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and med
| Condition(s) | MRD |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS). |
| Who can participate | Inclusion Criteria: 1. Written informed consent provided. 2. Males or females aged ≥18 years, \< 80 years. 3. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. 4. Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating mutation. 5. Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy. 6. ECOG performance status 0-1. 7. Life expectancy ≥12 weeks. 8. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.8 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level). 9. Adequate liver function: Total bilirubin ≤ 1.5 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Guangdong Association of Clinical Trials |
| Locations | Beijing, China; Chongqing, China; Foshan, China; Fuzhou, China; Guangzhou, China; Guangzhou, China (+10 more sites) |
| Start date | 2022-09-13 |
| NCT ID | NCT05536505 |
| Official listing | https://clinicaltrials.gov/study/NCT05536505 |