A biomarker analysis of plasma and tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.

UMIN ID: UMIN000013806

Registered date:07/05/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: adenocarcinoma of the lung
• Date of first enrollment: 2014/05/07
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Afatinib40mg/day:oral daily

Outcome(s)

• Primary Outcome: A detection of a biomarker about afatinib tolerance

Secondary Outcome

1.Progression Free Survival
2.Time to Systemic PD
3.Response rate
4.Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Exclude criteria

1) Patients with active double cancer
2)Patients with interstitial pneumonia confirmed by chest CT.
3)Patient with neurologic symptom caused by non-treated brain metastasis
4) Patients with either superior vena cava syndrome, pericardial effusion, pleural effusion or ascites >= Grade 3.
5) Patients with an operation with the systemic anesthesia within 28 days before enrollment.
6)Patient with a palliative radiotherapy for the metastatic focus except the chest (including gamma knife treatment for the brain metastatic focus) within 7 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0).
7) Patient with a radiation exposure to the chest or mediastinum within 14 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0).
8)Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study.
9) Patient with positive HBs antigen.
10) Patient having a serious infection to need systemic treatment.
11)Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information

• Primary Sponsor: Clinical Research Support Center Kyushu
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd.