Non-small Cell Lung Cancer Clinical Trial
Official title:
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study
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.
Status | Recruiting |
Enrollment | 114 |
Est. completion date | July 1, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hopital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival rate at 3 years | The rate of survival patients without disease recurrence at 3 years | 3 years following the first dose of study drug | |
Secondary | Overall survival rate at 3 years | The rate of survival patients at 3 years | 3 years following the first dose of study drug | |
Secondary | Median disease-free survival | The median time from the enrollment to the disease recurrence or death depending on the protocol | Approximately 3 years following the first dose of study drugs | |
Secondary | Median overall survival | The median time from the enrollment to death of any cause depending on the protocol | Approximately 5 years following the first dose of study drugs | |
Secondary | Adverse events | The number of patients with adverse events and the severity according to CTCAE v5.0 | Approximately 3 years following the first dose of study drugs |
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