Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
- Registration Number
- NCT05445310
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 114
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Furmonertinib Furmonertinib Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons.
- Primary Outcome Measures
Name Time Method Disease-free survival rate at 3 years 3 years following the first dose of study drug The rate of survival patients without disease recurrence at 3 years
- Secondary Outcome Measures
Name Time Method Median disease-free survival Approximately 3 years following the first dose of study drugs The median time from the enrollment to the disease recurrence or death depending on the protocol
Overall survival rate at 3 years 3 years following the first dose of study drug The rate of survival patients at 3 years
Median overall survival Approximately 5 years following the first dose of study drugs The median time from the enrollment to death of any cause depending on the protocol
Adverse events Approximately 3 years following the first dose of study drugs The number of patients with adverse events and the severity according to CTCAE v5.0
Trial Locations
- Locations (1)
Peking Union Medical College Hopital
🇨🇳Beijing, China