Lung Cancer
Conditions
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of lung adenocarcinoma, and treated with standard lung cancer radical resection (lobectomy+hilar and mediastinal lymph node dissection)or or segmentectomy for tumor less than 2 cm; 2. Patients are pathologically confirmed to be stage IB or pure solid stage IA2-3 invasive non-small cell lung cancer ; 3. Aged 18-75 years; 4. The Eastern Cooperative Oncology Group Performance Status of 0 to 1; 5. Patients with primary non-small cell lung cancer with 2 common EGFR mutations(EGFR 19 Del or 21 L858R); 6. The diagnosed patients have not previously received chemotherapy, radiotherapy and targeted therapy related to lung cancer before; 7. Normal function of major organs: (1) The standard of routine blood examination shall meet the following requirements: (No blood transfusion and blood products have been given within 14 days, and G-CSF and other hematopoietic stimulating factors have not been used for correction). 1)ANC >= 1.5x10^9/L; 2)PLT >= 100x10^9/L; 3)Hb >= 100 g/L; (2) Biochemical examination shall meet the following standards: 1)TBIL = 50 ml/min(Cockcroft-Gault formula); 8. Women of childbearing age and men whose sexual partners are females of childbearing age should take appropriate contraceptive measures from screening to 6 months after stopping the study treatment; 9. For inclusion in study, patient must provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 2. Before the first dose of study treatment, there were toxic events that did not recover to CTCAE 5.0 grade 0 or 1 caused by previous treatment; 3. Suffering from severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding etc.; 4. Known HIV-infected persons and carriers (HIV antibody positive); 5. Active infections requiring antimicrobial treatment (for example, those requiring antibiotics, antiviral drugs, and antifungal drugs); 6. Patients with a history of pulmonary interstitial disease or concurrent pulmonary interstitial disease; 7. Previous or concomitant other uncured malignancies, except for cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer; 8. Received strong CYP3A4 inhibitor treatment within 7 days before randomization, or received strong CYP3A4 inducer treatment within 12 days before participating in the study; 9. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF); 2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 ms); 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval; 10. Patients who did not recover from major postoperative complications.
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);overal survival, OS;safety;ctDNA; | — |
Countries
China
Contacts
Public ContactChao Cheng
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed