A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
- Conditions
- EGFR-T790M positive non-small-cell lung cancer relapsed after 3rd generation EGFR-TKI
- Registration Number
- JPRN-UMIN000025126
- Lead Sponsor
- Kurume University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer). 2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan. 3) Symptomatic brain metastasis (clinically stable brain metastasis is eligible) 4) HBs antigen-positive 5) Infection requiring systemic treatment 6) Patients who, in the opinion of the attending physician, are inappropriate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection of biomarker for afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment
- Secondary Outcome Measures
Name Time Method progression free survival, response rate, safety