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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles
Tangdu Hospital
Xi'an, Shannxi, China
Objective response rate
the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1
Time frame: 7 days before surgery
Major pathological response rate
MPR was defined as the presence of ≤10% residual viable tumor cells in the primary tumor and all lymph nodes from surgical specimens following R0 resection, and the MPR rate was subsequently calculated as the proportion of patients who achieved MPR
Time frame: 7 days after surgery
Pathological complete response rate
pCR was defined as the absence of viable tumor cells in the primary tumor and all sampled regional lymph nodes from surgical specimens following R0 resection, and the pCR rate was calculated as the proportion of patients achieving this response
Time frame: 7 days after surgery
R0 resection rate
the proportion of patients achieving R0 resection among all patients undergoing tumor resection surgery
Time frame: 7 days after surgery
the TNM downstaging rate
defined as the proportion of patients whose post-neoadjuvant therapy TNM stage (prior to surgery) was lower than their baseline TNM stage
Time frame: 7 days before surgery
Event-free survival
defined as the time from the date of informed consent to loss of surgical eligibility due to disease progression, postoperative recurrence, or death from any cause
Time frame: 2 years
Overall survival
The time from enrolment to death of any reason
Time frame: Approximately 5 years following the first dose of study drugs
drug safety and surgical complications
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and Number of participants with surgical complications as assessed by Clavien-Dindo
Time frame: Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.
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