Status:
RECRUITING
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)
Lead Sponsor:
Tang-Du Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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/pe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05430802
Start Date
February 24 2022
End Date
March 1 2026
Last Update
June 24 2022
Active Locations (1)
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1
Tangdu Hospital
Xi'an, Shannxi, China