EGFR-TKI Resistant Mutation
Conditions
Keywords
Progression-Free Survival
Brief summary
EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.
Detailed description
1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.
Interventions
OTHERhistory data
history data of PFS after 1st line or second line theray
Sponsors
Qingdao Central Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.
Exclusion criteria
* liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival Time (PFS) | an average 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate(ORR) | an average half year |
| Overall Survival Time (OS) | an average 2 year |
Countries
China
Outcome results
None listed