Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Pathological or cytological diagnosis of stage IV lung cancer with tumor patients; (2) EGFR gene mutations, including exon 19 deletion mutation (19DEL), exon 21 point mutation (21L858R), 18 exon G719X, 20 exon S768I and 21 exon L861Q mutation are also sensitive Sexual mutation, T790M mutation. (3) Aged >= 18 years; (4) The estimated survival period is >= 3 months; (5) The subject has no major organ dysfunction. Blood routine, liver, kidney, and cardiac function are normal: hemoglobin >= 120g / L, absolute neutrophil count (ANC) >= 1.5 x 10^9 / L, platelet >= 80 x 10^9 / L, bilirubin <= 1.5ULN, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN. INR <= 1.5, creatinine <= 1.5ULN.
Exclusion criteria
Exclusion criteria: (1) Have a history of other tumors within 5 years; (2) T790M mutation carrying 20 exons, intended to be treated with EGFR-TKI first-generation drugs; (3) Those with an expected life expectancy of level II in NYHA cardiac function. Patients with unstable angina (symptoms of angina at rest) or newly occurring angina (starting in the past 3 months) or myocardial infarction occurred in the past 6 months. Active infection, > Level 2 adverse events (CTC AE. Version 4.0); (6) Pregnant or lactating patients; (7) People with a history of mental illness that is difficult to control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP clinical progression pattern stratification;blood routine;stool routine;urine routine;liver function;renal function;FACT-L;LCSS;objective response rate;TCM syndrome evaluation; | — |
Countries
China
Contacts
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine