NCT06864624 Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
| NCT ID | NCT06864624 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tang-Du Hospital |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
This is a single-arm, phase 2 study to investigate the efficacy and safety of sunvozertinib as neoadjuvant and adjuvant treatment for stage II-IIIB non-small-cell lung cancer patients with EGFR exon20 insertion mutation.
Eligibility Criteria
Inclusion Criteria: 1. Patients must understand the requirements and content of the clinical trial and provide a handwritten signed and dated informed consent. 2. Age ≥ 18 years old. 3. Non-small cell lung cancer confirmed by histopathology or cytology, clinical stage II, IIIA or IIIB (N2) assessed by the investigator according to AJCC 8th edition. 4. EGFR exon 20 insertion mutation confirmed by an approved local laboratory. 5. No disease progression in the past two weeks of signing the informed consent form and a score of 0-1 according to the ECOG criteria, and no significant progression within 2 weeks before the first dose. 6. At least one measurable target lesion according to RECIST v1.1. 7. Adequate bone marrow and other organ reserve: * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L * Platelets ≥ 100 × 109/L * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 1.5 ×ULN; in patients with Gilbert syndrome, total bilirubin ≤ 3 × ULN * ALT≤ 2.5 × ULN and AST≤ 2.5 × ULN * Creatinine ≤ 1.5 × ULN, a