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This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.
The primary endpoint: 2-year DFS rate; The second endpoint: DFS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Furmonertinib (80 mg orally, once daily) for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib | Drug | Furmonertinib (80 mg orally, once daily) for 3 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS) rate at 2 years | Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate. | From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS) | Assess the Efficacy of Adjuvant Furmonertinib as Measured by Disease Free Survival (DFS). | From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. |
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Inclusion Criteria:
1) Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0~10×10^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio(INR)≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN 8. No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded; 9. Subjects have voluntarily participated, signed and dated informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Fan, MD | Contact | 15901013210 | fan_jiang@tongji.edu.cn | |
| Xiao-Long Li, MD | Contact | 15121035752 | lixl_810@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Fan, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| C000705711 | aflutinib |
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