Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Furmonertinib Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons. |
Drug: Furmonertinib
Furmonertinib 80mg/d
|
Outcome Measures
Primary Outcome Measures
- 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
- Overall survival rate at 3 years [3 years following the first dose of study drug]
The rate of survival patients at 3 years
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
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Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
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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.
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EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
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ECOG performance status 0-1.
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Sufficient organ function in liver, renal, kidney and hematology.
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With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.
Exclusion Criteria:
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Lung cancer with small cell or neuroendocrine cancer cell.
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EGFR exon 20 insertion positive.
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Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
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Women who are pregnant or breastfeeding.
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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 enrolment.
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Concurrent with other malignancies excluding carcinoma in situ.
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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.
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Gastrointestinal disorders which may affect drug taking or absorption.
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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.
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With history of interstitial lung disease or relative risk.
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Allergic to any component of furmonertinib tablet.
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Mental illness or drug abuse.
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Live vaccination within 30 days before enrolment.
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Other situation judged by investigator such as failure to follow the rules of study.
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Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrolement.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AST-PMR2201