EGFR mutation-positive advanced NSCLC
Conditions
Interventions
Sponsors
Chengdu Fifth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced non-small cell lung cancer (NSCLC) confirmed by histopathology or cytology, who can not be operated or have postoperative recurrence and metastasis [2009 IASLC international lung cancer staging (8th Edition) TNM stage III B-IV, see Appendix 2 of the trial protocol], according to the definition of the joint committee on cancer staging standards, they are not suitable for radical treatment; To confirm EGFR 19del or L858R mutation according to the detection method recommended by "expert consensus on detection of epidermal growth factor receptor gene mutation in Chinese patients with non-small cell lung cancer"; [Chinese Journal of Pathology, 2011,40 (10): 700-702] 2. Patients over 18 years old (including boundary value) have no gender limitation; 3. Patients with ECoG score of 0-2 have a life expectancy of at least 3 months; 4. According to RECIST 1.1 evaluation standard of solid tumor efficacy, patients with at least one measurable lesion can be accurately measured; 5. Patients who have received surgery in the past should be evaluated by the researcher to have recovered and the time of surgery completion should be at least 4 weeks from the enrollment; 6. For the patients who have received radiotherapy for the target lesions in the past, the radiation dose should not be greater than 60Gy. At the time of entering the study, the previous radiotherapy must have been completed for at least 3 months, and the acute toxic reactions caused by the previous radiotherapy must have been recovered. The non target lesions can be treated with local radiotherapy according to the judgment of the researcher; 7. Patients with normal bone marrow reserve or organ function should meet the following laboratory test values: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9 / L, platelet count >= 75 x 10^9 / L, and hemoglobin count >= 80g / L (2) Bilirubin < 1.5 times the upper limit of normal value, alkaline phosphatase (ALP / AKP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal value (if there is liver metastasis, ALP / AKP, AST, ALT <= 5 times the upper limit of normal value); (3) Serum creatinine <= 1.5 times the upper limit of normal value; 8. Patients whose compliance and geographical location of residence meet the needs of follow-up; 9. Patients who have not participated in clinical trials of other drugs within one month; 10. Patients of childbearing age voluntarily take contraceptive measures, and women's pregnancy test is negative; 11. Patients who were informed of the trial before the start of the trial voluntarily signed their names and dates in the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to any component of Endostar or antibody preparation; 2. Patients with previous severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction and severe heart valve disease; 3. Patients who planned to receive systemic anti-tumor therapy within 4 weeks before grouping or during the medication period of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C was used within 6 weeks before receiving the trial drug treatment); 4. Patients with brain metastases accompanied with symptoms or symptoms controlled for less than one month; 5. Patients who received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping; 6. The patients whose imaging showed that the tumor had invaded the important blood vessels or the tumor was likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage; 7. Within 6 weeks before grouping, patients with any bleeding or bleeding event >= CTCAE grade 3 had unhealed wound, ulcer or fracture; 8. Patients with arteriovenous thrombosis within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism; 9. According to the judgment of the researcher, those patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Quality of Life;safety; | — |
Countries
China
Contacts
Public ContactHe Lang
Chengdu Fifth People's Hospital
Outcome results
None listed