EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
- Conditions
- Nonsmall Cell Lung Cancer
- Registration Number
- NCT02988141
- Lead Sponsor
- Jianxing He
- Brief Summary
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC
- Detailed Description
Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures.
- Male or female patients aged 18 years and older.
- Histological confirmation of stage IIIB/IV NSCLC.
- Documented EGFR mutation positive .
- WHO Performance Status 0, 1 or 2
Exclusion Criteria
- Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
- Previous (within 6 months) or current treatment with AZD9291.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The biomarker profile of EGFR-TKI resistance Baseline
- Secondary Outcome Measures
Name Time Method The concordance, sensitivity and specificity in paired blood and tissue samples Baseline