EGFR mutation-positive lung adenocarcinoma
Conditions
Interventions
None listed
Sponsors
Sendai Kosei Hospital
Division of Health Medical Computational Science, Health Intelligence Center, The Institute of Medical Science, The University of Tokyo Genomedia Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Estimated life expectancy > 3 months 2) Written informed consent for participation in this study is obtained 3) Patients with stage IV, recurrent or Stage IIIB/C, without any indication for radical radiation therapy, lung adenocarcinoma who received no prior chemotherapy. 4) Lung adenocarcinoma that is histologically or cytologically diagnosed as well as confirmed as EGFR mutation positive by the validated methods for the detection of EGFR mutations. 5) Patients who are judged suitable for Afatinib therapy by investigators. 6) Measurable disease as defined by RECIST guideline (ver. 1.1)
Exclusion criteria
Exclusion criteria: 1) History of any type of malignancy within the past 5 years (including carcinoma in situ). 2) History of organ transplantation (including hematopoietic stem cell transplantation) 3) Major surgery within one month prior to the first blood sampling in this study. 4) Radiotherapy for brain metastatic or other locally advanced lesions within two weeks prior to the first blood sampling in this study. 5) Concomitant presence of distinct types of lung cancer is confirmed: - Patients with histologically distinct types of lung cancer, including lung squamous cell carcinoma and small cell lung cancer, will be excluded. - Patients with distinct lung adenocarcinomas harboring ALK translocation or ROS1 translocation will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mathematical modeling to understand the dynamics of lung cancer evolution. | — |
Countries
Japan
Contacts
Public ContactTomoiki Aiba
Sendai Kosei Hospital Respiratory medicine
Outcome results
None listed