A study to confirm the detection rate of EGFR T790M in bronchial washings of non-small cell lung cancer patients and the therapeutic effect of Lecraza® in T790M positive patients
- Conditions
- Neoplasms
- Registration Number
- KCT0009390
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
1. Adult males or females aged 18 years or older.
2. Patients diagnosed with locally advanced or metastatic non-small cell lung cancer.
3. Patients diagnosed with histologically or cytologically confirmed mEGFR (+) adenocarcinoma of the lung.
4. Patients who have received treatment with a first-line EGFR-TKI approved in the country.
5. Patients who have experienced recurrence while on first-line EGFR-TKI therapy after the start date of the study.
6. Patients for whom the response to first-line EGFR-TKI therapy can be evaluated.
7. Patients who have provided consent for and undergone tissue biopsy, blood sample collection, and bronchoscopy for EGFR mutation confirmation.
8. Patients who have provided written consent for participation in the study.
Patients who discontinued treatment with first-generation or second-generation EGFR-TKIs for reasons other than disease progression.
Patients for whom medical records are not available for review.
Patients who cannot undergo all tests required for selection criterion 7) due to overall health status or other reasons.
Patients for whom any form of intervention for cancer treatment occurred between bronchial washing fluid and blood sample collection.
Individuals who have not consented to undergo testing and provide samples.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate, ORR
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS), Duration of Response (DoR), Time to Tumor Progression (TTP)