Non-Small Cell Lung Cancer
Conditions
Interventions
Group 1:Local Therapy(Added when TKIs come to the best efficacy)
Group 2:Local Therapy(Added when TKIs resistance occurs)
Group 3:Regular Clinical Therapy(Continued use of TKIs after TKIs resistance occurs)
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (>= 18 years),male or female; 2. Histologically or cytologically documented EGFR exon 19 or 21L858R mutant patient of lung adenocarcinoma; 3. ECOG PS 0-2; 4. First-line chemotherapy failure or intolerance,life expectancy >= 3 months; 5. Receiveing and to receive EGFR-TKI therapy,not resistant yet; 6. Eligible for attending local therapy according to the research scheme; 7. At least one measurable target lesion (non-irradiated part,conforms to RECIST,spiral CT minimum diameter>=10mm); 8. Adequate laboratory test results for organ systems, as follows: (1) Hematology: Absolute neutrophil count (ANC)>= 1.5 x 10^9/L; Hgb >= 80g/L; Platelets >= 80 x 10^9/L; (2) Serum biochemistry: Serum total bilirubin and direct bilirubin<=1.5 ULN; Aspartate transferase (AST; serum aspartate aminotransferase [SGOT]) and alanine aminotransferase (ALT; serum alanine aminotransferase [SGPT]) <= 2.5 ULN, subjects with liver metastasis AST, ALT <= 5 ULN; (3) Blood coagulation: Prothrombin time international normalized ratio(PT INR)<=1.5 ULN; 9. Male and female patients who are not surgically sterile or post-menopausal must agree to remain abstinent (refrain from heterosexual intercourse) or use reliable methods of birth control for the duration of the study and for 6 months after the last administration of study treatment. Male partners of female patients should use condoms for the duration of the study, and for 6 months after the last administration of study treatment; 10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Implement palliative radiotherapy or surgery to the primary and metastatic lesion; 2. CR images demonstrate specific interstitial pneumonia and pulmonary fibrosis; 3. Severe infection(intravenous antibiotics antifungal and antiviral therapy are needed), severe syndrome of inappropriate secretion of antidiuretic hormone, diabete inadequately controlled*, superior vena caval syndrome that needs treatment and other severe complications; *More than 40 units of insulin need to be administered continuously every day, or with 40 units of insulin per day for continuous use (or not used), fasting blood glucose is still above 140mg/dL, HbA1c is above 9.0. 4. Severe cardiovascular disease,including uncontrolled high blood pressure,unstable angina pectoris,myocardial infarction in the last 6 months,congestive heart failure (NYHA >= grade III) and severe arrhythmia; 5. Bleeding(CTCAE>=grade III) in the first 4weeks of the enrollment; 6. Long-term use of anticoagulants or vitamin K antagonists, such as warfarin, heparin or its analogues, but excluding the use of small doses of warfarin (<=1mg/d) or aspirin (<=100mg/d) for prevention purposes; 7. Patients with active recurrent cancer (excluding intraepithelial neoplasia and recurrent cancer that has not recurred for more than 5 years); 8. Pregnant/possibly pregnant/no effective contraceptive and lactating women; 9. Other researchers think that they can not complete the clinical 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; | — |
Countries
China
Contacts
Public ContactMingfang Zhao
The First Affiliated Hospital of China Medical University
Outcome results
None listed