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

Recruiting now · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT05430802
Run by: Tang-Du Hospital
People needed: 40
Starts: 2022-02-24
Expected to finish: 2026-09-01
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Tangdu Hospital — Xi'an, Shannxi, China (enrolling)

Full record on ClinicalTrials.gov

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