Clinical trial NCT05430802: Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: furmonertinib
AST2818
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: Approximately 9 weeks following the first dose of study drug
Secondary outcomes:
measure: Major pathological response rate
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Pathological complete response rate
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: R0 resection rate
timeFrame: Approximately 12 weeks following the first dose of study drugs
measure: Disease free survival
timeFrame: Approximately 3 years following the first dose of study drugs
measure: Overall survival
timeFrame: Approximately 5 years following the first dose of study drugs
measure: Pathological downstaging of lymph node rate
timeFrame: Approximately 12 weeks following the first dose of study drugs
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shannxi
Study officials:
References: