Furmonertinib before surgery for stage II–IIIB EGFR-mutant NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates neoadjuvant furmonertinib in adults with resectable stage II–IIIB NSCLC that harbors EGFR mutations. Eligible participants receive furmonertinib before planned surgical resection to assess tumor response and safety. The study includes patients with measurable disease and adequate organ function, and required baseline imaging and tumor mutation confirmation. Outcomes focus on tumor shrinkage, surgical feasibility, safety, and preliminary data on disease control. The trial aims to determine whether this EGFR TKI can improve operability and early outcomes compared with standard approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1）Provide informed consent prior to any study specific procedures
* 2）at least 18 years of age，not more than 75 years
* 3）Histology or cytology diagnose of non-small cell lung cancer within 60 days
* 4）ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
* 5）Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients
* 6）According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
* 7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
* 8）Without prior anti-tumor treatment
* 9\) Withe adequate organ function of hematology, liver and kidney
* 10）Using adequate and effective contraception, Male patients should be use condoms; 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:

* 1）Dual or multiple primary NSCLC
* 2）Any prior anti-tumor treatment
* 3）With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
* 4）History of interstitial lung disease or with relative risk factors
* 5）Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
* 6）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
* 7）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
* 8）Prolongation of ECG QTc or with relative risk factors
* 9）psychopath and/or mental illness
* 10）Pre-existing or coexisting bleeding disorders
* 11）Women with pregnancy or breastfeeding
* 12）Allergic to study drugs or any component
* 13）Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate

Where it's running

• 180 Fenglin Road
  Shanghai, China Recruiting

Study contacts

• Study coordinator: di ge
• Email: gedi@zs-hospital.sh.cn
• Phone: 86-18202188606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.