drugset / Trial / NCT05430802
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)
NaSingle-groupOpen-labelTreatment
Summary
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
Timeline
- Start
- 2023-01-10
- Primary completion
- 2025-09-01
- Completion
- 2029-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firmonertinib | Small molecule | 80 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | cisplating | Unknown | 75 mg/m2 | Intravenous |