drugset / Trial / NCT05430802

Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)

NCT05430802 ↗

Phase 2 Active not recruiting 40 enrolled Tang-Du Hospital
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

EvaluationDrugModalityDoseRoute
Subject Firmonertinib Small molecule 80 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject cisplating Unknown 75 mg/m2 Intravenous