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A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.

Not Applicable
Recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
progression free survival, response rate, safety
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