Neoadjuvant treatment for resectable lung cancer with specific mutations
Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study
This study is testing a new treatment combining furmonertinib with chemotherapy for people with specific types of lung cancer before they have surgery to see if it helps them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tang-Du Hospital Academic / other |
| Drugs / interventions | furmonertinib |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT05430802 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm phase 2 study aims to recruit 40 patients with EGFR mutated stage IIIA-IIIB resectable non-small cell lung cancer (NSCLC). Participants will receive furmonertinib for 9 weeks in combination with cisplatin and pemetrexed for 3 cycles as neoadjuvant therapy prior to radical surgery. The study will evaluate the efficacy of this treatment through radiological and pathological assessments before and after therapy, while also monitoring adverse events and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with EGFR mutation positive, resectable stage IIIA-IIIB NSCLC who have not received prior anti-tumor treatment.
Not a fit: Patients with EGFR exon 20 insertions or those with mixed small cell lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve surgical outcomes and overall survival for patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promising results with similar neoadjuvant approaches in treating EGFR mutated lung cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 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
Where this trial is running
Xi'an, Shannxi
- Tangdu Hospital — Xi'an, Shannxi, China (Recruiting)
Study contacts
- Study coordinator: Jie Lei, MD
- Email: leijiemd@163.com
- Phone: 15094079004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.