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

Tang-Du Hospital

Status and phase

Enrolling

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Furmonertinib+cisplating/pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT05430802

PMR-21011

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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