Advanced non-small cell lung cancer with positive ALK gene.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 18-75 years; 2. PS0-2; 3. Patients with non-small cell lung cancer confirmed by histology or cytology and alk mutation detected; 4. Patients with a life expectancy greater than 12 weeks; 5. Patients willing to sign informed consent; 6. Patients with assessable lesions in the lung or in the metastatic site, the largest lesion is greater than 1 cm; 7. Patients who can follow the research and follow-up procedure.
Exclusion criteria
Exclusion criteria: 1. Patients with any unstable systemic diseases (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases); 2. Patients who have received systematic anti-tumor treatment with ALK inhibitors before treatment; 3. Patients who received radiotherapy for brain metastasis; 4. Any obvious eye abnormality, especially severe dry eye syndrome, dry keratoconjunctivitis, severe exposure keratitis or other diseases that may increase epithelial damage; 5. Patients who are unable to receive oral administration, need intravenous high-energy nutrition, have previously had surgery affecting absorption or have active peptic ulcer; 6. Lactating women; 7. Patients with granulocyte count less than 1.5*10^9/L and platelet count less than 75*10^9/L; 8. Patients whose serum bilirubin is 1.5 ULN; 9. AST and ALT were more than 2 ULN, and 5 ULN in case of liver metastasis. Serum creatinine was 1.5 ULN, or creatinine clearance rate was less than 50ml/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Maoming People's Hospital of Guangdong Province, China