non-small cell lung cancer (NSCLC)
Conditions
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient was diagnosed as non-small cell lung cancer by pathology, and received standard radical resection of lung cancer (lobectomy + hilar mediastinal lymph node dissection) or segmental resection below 2cm; 2. Postoperative pathological staging was stage IB or pure solid stage IA2-3 invasive non-small cell lung cancer; 3. Aged 18-75 years; 4. The ECOG or PS score is 0 or 1; 5. The patient had a classical mutation of EGFR (EGFR 19 Del or 21 L858R) in primary non-small cell lung cancer; 6. The diagnosed patient had not previously received chemotherapy, radiotherapy or targeted therapy associated with lung cancer; 7. Normal function of major organs; 8. Female patients of childbearing age or male patients whose sexual partners are female of childbearing age shall take effective contraceptive measures during the whole treatment period and 6 months after the treatment period; 9. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Only segmental resection or cuneiform resection was performed; 2. Insufficient bone marrow reserve; 3. Significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 4. Toxic events caused by prior treatment that did not revert to CTCAE5.0 level 0 or 1 before the first dose of study therapy; 5. Severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, etc.; 6. Known HIV infected persons and carriers (HIV antibody positive); 7. Active infections that require antimicrobial treatment (e.g. antibiotics, antiviral drugs, antifungal drugs); 8. Patients with a history of or co-existing pulmonary interstitial disease; 9. Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder carcinoma; 10. Those who had received potent CYP3A4 inhibitor therapy within 7 days before randomization, or had received potent CYP3A4 inducer therapy within 12 days before entering the study; 11. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) >470ms, and 3 ECG QTc values obtained by clinical ECG were used for screening; (2) Any clinically important abnormality in rhythm, conduction or morphology of resting ECG; (3) Any factors that increase the risk of prolonged QTc or arrhythmia events, or sudden unexplained death of a first-degree relative under 40 years of age or taking any medication known to prolong the QT interval; 12. Patients with major postoperative complications that did not recover.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 4 years disease-free survival (DFS);5 years disease-free survival (DFS);overall survival;safety;circulating tumor DNA; | — |
Countries
China
Contacts
Public ContactCheng Chao
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed