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This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Icotinib oral 125mg tid for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Within 4-6 weeks after surgery, Icotinib 125mg orally, TID was started for 2 years, or treatment was discontinued due to tumor recurrence or intolerance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first. | Up to approximately 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomisation until death due to any cause. | Up to approximately 10 years |
| Safety and tolerability | AEs graded by CTCAE version 5.0 |
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Inclusion Criteria:
Male or female, at least ≥ 18 years,and ≦ 80 years
Lung adenocarcinoma.
Stage I disease(IA or IB), based on TNM8 classification.
There is at least one of the following high-risk factors:
Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy.
A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation
World Health Organization performance status of 0 or 1.
Bood routine: HB > 80g/L; ANC > 1.0x109/L; PLT > 50x109/L.Blood biochemistry: ALT and AST < 2.5 times the upper limit of normal; Crea < 1.5 times the upper limit of normal.
Good adherence to follow-up.
During the trial and for 3 months after the trial,Participants must be using highly effective contraceptive measures.
Exclusion Criteria:
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| Up to approximately 10 years |
| 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 |
|---|---|
| C531470 | icotinib |
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