Using furmonertinib after surgery for high-risk non-small cell lung cancer

Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study

This study is testing if taking furmonertinib after surgery can help people with high-risk non-small cell lung cancer stay cancer-free longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: furmonertinib, chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05445310 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of furmonertinib, administered at a dose of 80mg per day, as an adjuvant treatment for patients with stage IA non-small cell lung cancer with high-risk factors and stage IB non-small cell lung cancer. It is a prospective, single-arm study that aims to enroll 114 patients who have undergone radical resection without prior anti-tumor therapies. The primary endpoint is to evaluate the disease-free survival rate at three years post-surgery.

Who should consider this trial

Good fit: Ideal candidates are patients who have undergone radical resection for stage IA non-small cell lung cancer with high-risk factors or stage IB non-small cell lung cancer and have EGFR mutations.

Not a fit: Patients who have received prior anti-tumor therapies or do not have EGFR mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for patients with high-risk non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with targeted therapies in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
* Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
* Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
* EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
* ECOG performance status 0-1.
* Sufficient organ function in liver, renal, kidney and hematology.
* With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.

Exclusion Criteria:

* Lung cancer with small cell or neuroendocrine cancer cell.
* EGFR exon 20 insertion positive.
* Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
* Women who are pregnant or breastfeeding.
* Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
* Concurrent with other malignancies excluding carcinoma in situ.
* With uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections requiring injection of antibiotics.
* Gastrointestinal disorders which may affect drug taking or absorption.
* With history of QT prolongation or relative risk factors including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.
* With history of interstitial lung disease or relative risk.
* Allergic to any component of furmonertinib tablet.
* Mental illness or drug abuse.
* Live vaccination within 30 days before enrollment.
* Other situation judged by investigator such as failure to follow the rules of study.
* Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.

Where this trial is running

Beijing

• Peking Union Medical College Hopital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Ruixuan Geng, MD

Conditions: Non-small Cell Lung Cancer