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

Korábbi kezelés

• Any prior anti-tumor treatment
• Major surgery within 4 weeks before enrollment
• Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment

Más betegség

• Mixed with small cell cancer, or other mixed types of lung cancer
• 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
• History of interstitial lung disease or with relative risk factors
• Allergic to study drugs or any component

Laborértékek

• EGFR Exon 20 insertions positive
• Prolongation of ECG QTc or with relative risk factors

Egyéb

• Women with pregnancy or breastfeeding
• Inadequate organ function of hematology, liver and kidney
• Poor adherence or other situation judged by investigator
• Patients who had participated other clinical studies of tumors

• With written informed consent before any study procedure
• Histology or cytology diagnose of non-small cell lung cancer within 60 days
• Stage IIA-IIIB (T3N2M0 only), 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
• 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