Non-small cell lung cancer
Conditions
Interventions
A:Icotinib Hydrochloride Tablets
B:Pemetrexed Disodium for Injection
B:Carboplatin Injection
B:Cisplatin Injection
B:Icotinib Hydrochloride Tablets
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed stage II-IIIA (N1-N2) (AJCC7) breast cancer undergoing radical resection, with no distant metastasis and hilar, mediastinal or supraclavicular lymph node metastasis found by preoperative examination. 2. Epidermal growth factor receptor( EGFR) sensitive mutation. 3. Age range 18-75 years. 4. Subject is able to take oral medication. 5. Electrocorticogram( ECOG) status score of 0-1. 6. Treatment started 3-6 weeks after radical resection of lung cancer. 7. Hematological parameters: absolute neutrophil count >= 1.75 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 9.0 g/dL (can be maintained by transfusion). 8. Liver function criteria: total bilirubin = 66ml/min. 10. Women of childbearing age must have a negative urine pregnancy test within 7 days prior to initial treatment and are not breastfeeding, and men must agree to use appropriate methods of contraception or have been surgically sterilized during the trial and after dosing with trial drug. 11. Subjects are able to comply with study and follow-up procedures. 12. Subjects have the ability to understand and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who have received previous chemotherapy or systemic anti-tumor therapy (including targeted therapy, immunotherapy, etc.). 2. Local lesions have previously received local treatments such as radiotherapy or radiofrequency. 3. If subjects suffer from other malignant tumors in the past 5 years, excluding cured basal cell carcinoma, cervical carcinoma in situ, and surgically treated localized prostate cancer or surgically removed ductal carcinoma in situ. 4. Subjects with exon T790M mutation in EGFR 20. 5. Major heart disease such as acute myocardial infarction within 6 months. 6. Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence of idiopathic pulmonary fibrosis on baseline CT scan. 7. Large pleural effusion or pericardial effusion. 8. Any unstable systemic disease (including active infection, poorly controlled high blood pressure, unstable angina, congestive heart failure, liver, kidney or metabolic disease). 9. Any significant ocular abnormality, particularly severe dry eye syndrome, keratoconjunctivitis sicca, severe exposure keratitis, or other condition that may increase epithelial damage. Subjects who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery affecting absorption, active gastrointestinal ulcer, chronic diarrhea. 11. Subjects with any clinical evidence of moderate to severe chronic obstructive pulmonary disease (COPD) (High-risk factors of COPD, pulmonary function test FEV1/FVC<70%, FEV1<80% predicted value, with or without symptoms of chronic cough, sputum, dyspnea) and other active lung disease as judged by the investigator. 12. Subjects are allergy to platinum, pemetrexed, icotinib or related ingredients. 13. In the opinion of the investigator, the subject may not be able to complete the study or may not be able to comply with the requirements of the study (due to administrative or other reasons). 14. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;3-year DFS rate;3-year OS rate;QoL; | — |
Countries
China
Contacts
Public ContactDong Lan
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed