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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furmonertinib | Experimental | Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib | Drug | Furmonertinib 80mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate at 3 years | The rate of survival patients at 3 years | 3 years following the first dose of study drug |
| Median disease-free survival | The median time from the enrollment to the disease recurrence or death depending on the protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruixuan Geng, MD | Contact | 86-10-69158753 | ginkrice@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hopital | Recruiting | Beijing | China |
Blinded IPD are to be shared on the requirements of supervision department and overall results of the study are to be published on academic conferences and journals.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000705711 | aflutinib |
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| Approximately 3 years following the first dose of study drugs |
| 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 |
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |