In this open-label, single-arm, phase 2 study, 40 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive furmonertinib for 9 weeks combined with cisplatin/pemetrexed for 3 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.
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
RECRUITINGObjective response rate
The proportion of patients with complete response or partial response
Time frame: Approximately 9 weeks following the first dose of study drug
Major pathological response rate
The proportion of patients with pathological response in the resected tumor
Time frame: Approximately 12 weeks following the first dose of study drug
Pathological complete response rate
The proportion of patients with pathological response rate in the resected tumor
Time frame: Approximately 12 weeks following the first dose of study drug
R0 resection rate
The proportion of patients with R0 resection
Time frame: Approximately 12 weeks following the first dose of study drugs
Disease free survival
The time from enrolment to disease recurrence or death, which ever comes first
Time frame: Approximately 3 years following the first dose of study drugs
Overall survival
The time from enrolment to death of any reason
Time frame: Approximately 5 years following the first dose of study drugs
Pathological downstaging of lymph node rate
The proportion of patients with pathological downstaging of lymph node rate
Time frame: Approximately 12 weeks following the first dose of study drugs
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