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This is a phase II, prospective, multi-centre study. To assess the efficacy and safety of furmonertinib in patients with epidermal growth factor receptor 20ins mutation positive stage IB-IIIA Non-small Cell Lung Carcinoma, following complete tumour resection with or without adjuvant chemotherapy.
The study plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years.
The primary endpoint is DFS. The secondary endpoint include DFS rate , OS and the change of HRQoL.
In addition, the peripheral blood ctDNA will be collected and analyzed in this study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furmonertinib | Experimental | This arm plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib | Drug | This arm plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years. |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease-free-survival | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| DFS rate | Disease free survival (DFS) rate at 2, 3 and 5 years | 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 2,3,5 years. |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan cancer hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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Overall Survival
| From date of receiving therapy until date of death (by any cause in the absence of recurrence).Approximately 5 years following the first dose of study drugs |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000705711 | aflutinib |
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