EGFR-TKI Resistant Mutation Clinical Trial
Official title:
High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
Verified date | October 2015 |
Source | Qingdao Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2017 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Qingdao Central Hospital | Qingdao | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qingdao Central Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival Time (PFS) | an average 1 year | ||
Secondary | Overall Response Rate(ORR) | an average half year | ||
Secondary | Overall Survival Time (OS) | an average 2 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06071013 -
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT05598528 -
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
|
||
Recruiting |
NCT01994057 -
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
|
||
Recruiting |
NCT05256290 -
Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT02661009 -
Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
|
N/A | |
Not yet recruiting |
NCT02972333 -
Open Label, Prospective Study to Investigate Efficacy and Safety of AZD9291 in BM From NSCLC Patients With EGFR T790M
|
Phase 3 | |
Recruiting |
NCT06363734 -
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial
|
Phase 2 |