EGFR mutation positive late NSCLC
Conditions
Interventions
control group:single-agent gefitinib
Sponsors
Chengdu Fifth People's Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: [1] Patients with advanced non-small cell lung cancer who have been diagnosed by histopathology or cytology and cannot undergo surgery or recurrence after surgery [2009 IASLC International Lung Cancer Staging (eighth edition) TNM staging IIIB, IV, see Appendix II of the trial protocol]. According to the US Joint Committee on Cancer Staging Standards, it is not suitable for radical treatment; according to the Chinese non-small cell lung expert consensus on detection of epidermal growth factor receptor gene mutation in cancer patients, recommended detection means to confirm EGFR sensitive base positive for mutation. [Chinese Journal of Pathology, 2011, 40 (10): 700-702.] [2] The patient has at least one measurable lesion present. According to RECIST 1.1 (Appendix IV to the protocol); [3] Patients who have previously received radiation therapy can be enrolled, but the dose of radiotherapy should not exceed 60 Gy, the area must be = 1.5 x 10^9/L, platelets >= 100 x 10^9/L, and hemoglobin >= 90g / L. b) Liver: bilirubin = 50%; [10] Patients can understand the purpose of clinical trials and voluntarily participate in and sign informed consent; [11] Age over 20 years of age, gender is not limited; [12] Patients of childbearing age voluntarily adopt contraceptive measures and women have negative pregnancy tests.
Exclusion criteria
Exclusion criteria: [1] suffering from uncontrolled neurological, psychiatric or psychiatric disorders, poor compliance, unable to cooperate with and describe treatment response; Primary brain tumor or central nervous system metastasis is uncontrolled, with obvious cranial hypertension or neuropsychiatric symptom; [2] A single metastase can be controlled by radiotherapy; [3] Severe active infection (as determined by the investigator), active hepatitis patients; [4] bleeding tendency or coagulopathy; [5] There is a clear history of neurological or psychiatric disorders, including epilepsy or dementia; [6] Organ transplantation for long-term use of immunosuppressive drugs; [7] Pregnant or lactating women; [8] Arrhythmia requires treatment with antiarrhythmic disorders, previous history of symptomatic coronary artery disease (including angina and myocardial infarction) or history of myocardial ischemia or congestive heart failure exceeding NYHA class II (Appendix V of the trial protocol); [9] According to the investigator's judgment, is there a serious risk to the patient's safety or a concomitant disease that affects the patient's completion of the study; [10] There have been other malignant diseases other than cervical carcinoma in situ, or non-melanoma skin cancer, unless previously malignant; The disease was diagnosed and treated 5 years ago, and there is no evidence of subsequent recurrence. There is a low degree (Gleason score <= 6) patients with localized prostate cancer can be enrolled even if they are less than 5 years old. [11] Concomitant use of other targeted drugs during the trial; [12] Those who have participated in or are participating in other new drug clinical trials within one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Quality of Life; | — |
Countries
China
Contacts
Public ContactHe Lang
Chengdu Fifth People's Hospital
Outcome results
None listed