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Clinical Trials in China / NCT05430802
Active, not recruiting Phase 2

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

NCT05430802 · tracked via the Priya Life Science China tracker
Sponsor
Tang-Du Hospital
Phase
Phase 2
Started
2022-02-24
Last updated
2026-08-11

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Furmonertinib+cisplating/pemetrexed →

Furmonertinib+cisplating/pemetrexed: Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles

Study summary

In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 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 enrollment * Women with pregnancy or breastfeeding * 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 * 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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tangdu Hospital Xi'an Shannxi

More Tang-Du Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05430802 on ClinicalTrials.gov ↗ ← All trials in China