Non-small cell lung cancer
Conditions
Interventions
Elrotinib treatment
Sponsors
Keio University School of Medicine Division of Pulmonary Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histlogically or cytologically confirmed stage III/IV non-small cell lung cancer 2)Refractory cases to the prior one or two chemotherapies 3)No prior treatment with EGFR-TKI 4)Possible cases with oral administration 5)Patients with mesearable lesions as defined by RECIST 6)Performance Status(ECOG) 0-2 7)>= 70 years of age 8)Patients with adequate organ functions 9)Life expectancy more than three months 10) (a)Chemotherapy: more than 4weeks after the last chemotherapy (b)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs (C)Operation: more than 4weeks after the last operation(including pleurodesis) 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis 2)Patients with massive pleural or pericardial effusion ,or ascites 3)Patients with active severe infections 4)Cases with past history of administration of HER related agents 5)Impossible cases with oral administration 6)Patients with active opthalmological disease 7)Patients with symptomatic brain metastasis 8)Patients with active concomitant malignancy 9)Patients with uncontrollabe diabetes mellitus 10)Patients with uncontrollable complications 11)Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anticancer efficacy(response rate and disease control rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival,and safety | — |
Countries
Japan
Contacts
Public ContactKatsuhiko Naoki
Keio University School of Medicine Division of Pulmonary Medicine
Outcome results
None listed