Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGFurmonertinib
Furmonertinib 80mg/d
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactRuixuan Geng, MD
Outcome results
None listed