Lung Adenocarcinoma
Conditions
Interventions
experimental group:EGFR-TKI plus Surgery
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The informed consent form has been signed; 2. Able to follow the research protocol and follow-up procedures, and can take oral medications; 3. The patient's age is >= 18 years; 4. Histologically or cytologically confirmed lung adenocarcinoma, CT confirmed as newly-treated patients with stage IB-?A (according to UICC 2009 version of staging standards); 5. Gene detection of tissue samples has gene mutations applicable to EGFR-TKI; 6. The patient must have measurable lesions (according to RECIST 1.0 standard); 7. The ECOG score of physical strength is 0 to 1; 8. The following laboratory tests performed within 7 days before the first medication confirmed that the patients bone marrow, liver and kidney functions meet the requirements for participating in the study: (1) Hemoglobin >= 9.0 g/dL (this level can be maintained or exceeded by blood transfusion); (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9; (3) Platelet count >= 100 x 10^9/mm3; (4) Total bilirubin = 60ml/min; (7) The international normalized ratio of prothrombin time (INR) <= 1.5 and partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal for patients who have not received anticoagulation therapy. Patients receiving full-dose or parenteral anticoagulant drug treatment can enter clinical trials as long as the dose of anticoagulant drugs is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test test are within the limits of local treatment. 9. Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment and the result is negative. Male and female patients of the appropriate age must use reliable methods of contraception before entering the trial, during the study until 30 days after the drug is stopped. The reliable method of contraception will be determined by the principal investigator or designated personnel.
Exclusion criteria
Exclusion criteria: 1. Any systemic anti-cancer therapy for NSCLC, including cytotoxic drug therapy, targeted drug therapy (including tyrosine kinase inhibitors or monoclonal antibodies), and experimental therapy; 2. Local radiotherapy for NSCLC; 3. Patients who had cancer other than NSCLC in the five years before the start of treatment in this study. Exclude cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumors [including Ta and Tis]; 4. Any unstable systemic disease (including active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (= New York Heart Association [NYHA] Grade II), heart machine infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic diseases; 5. Have or currently suffer from interstitial lung disease; 6. Uncontrolled eye inflammation or eye infection, or any condition that may cause the above eye diseases; 7. Known human immunodeficiency virus (HIV) infection; 8. Allergy to erlotinib or any study drug; 9. Patients who have undergone major surgery or suffered severe trauma within 2 months before the first medication; 10. Patients with mixed components of small cell lung cancer; 11. Any situation that affects the patient to swallow the drug; 12. Any malabsorption; 13. Women who are pregnant or breastfeeding; 14. Situations deemed unsuitable by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;QOL;OS; | — |
Countries
China
Contacts
Public ContactMing Liu
Shanghai Pulmonary Hospital
Outcome results
None listed