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

Study Overview
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Brief Summary
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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.

Official Title
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Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Furmonertinib+cisplating/pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With written informed consent before any study procedure Histology or cytology diagnose of non-small cell lung cancer within 60 days Stage IIIA/IIIB, with resectable lesion(s) by radiology EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations) Without prior anti-tumor treatment With at least one measurable lesions (The longest axis ≥10mm) ECOG performance status 0-1 Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age Exclusion Criteria: EGFR Exon 20 insertions positive Mixed with small cell cancer, or other mixed types of lung cancer Any prior anti-tumor treatment Major surgery within 4 weeks before enrolment Women with pregnancy or breastfeeding Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment With history of other malignancy except for radical resected tumors without recurrence for 5 years or more With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment Severe gastrointestinal diseases which may affect the intake and absorption of study drug Prolongation of ECG QTc or with relative risk factors History of interstitial lung disease or with relative risk factors Inadequate organ function of hematology, liver and kidney Allergic to study drugs or any component Poor adherence or other situation judged by investigator Patients who had participated other clinical studies of tumors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furmonertinib plus cisplatin/pemetrexed<br>furmonertinib 80mg/d for 9 weeks and cisplatin 75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv at 21 day cycles for 3 cycles | Drug: Furmonertinib+cisplating/pemetrexed<br>* Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | The proportion of patients with complete response or partial response | Approximately 9 weeks following the first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathological response rate | The proportion of patients with pathological response in the resected tumor | 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 | Approximately 12 weeks following the first dose of study drug | 
| R0 resection rate | The proportion of patients with R0 resection | 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 | Approximately 3 years following the first dose of study drugs | 
| Overall survival | The time from enrolment to death of any reason | 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 | Approximately 12 weeks following the first dose of study drugs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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furmonertinib, AST2818