Non-small cell lung cancer
Conditions
Interventions
Daily 30mg of afatinib is orally administered until tumor progression or the onset of untolerable adverse events.
Sponsors
Saitama Lung Cancer Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are cytologically or histologically diagnosed with non-small cell clung cancer 2) Patients with non-small cell lung cancer harboring EGFR gene mutations (exon19 deletion, exon21 L858R, exon18 G719X, exon20 S768I, or exon21 L861Q) using tissue specimens or lavage fluid including pleural effusion 3) EGFR tyrosine kinase inhibitor-naive patients with the following stages a) stage IIIA with pulmonary metastases b) stage IIIB without indication of curative radiation therapy c) stage IV d) postoperative recurrence 4) Patients with measurable lesions acccording to RECIST criteria 5) Patients who are expected to survive more than 90 days from the time of enrollment 6) More than 75-year old patients at the time of enrollment 7) Patients who meet the following criteria a) Neutrophil; more than 1,500/mm3 b) Platelet; more than 100,000/mm3 c) Hemoglobin; more than 9.0g/dL d) Transaminases (AST and ALT); within 2.5XULN (institutional reference values) e) Serum total bilirubin (T-Bil); within 1.5XULN f) Serum creatinine (S-Cr); within 1.5XULN g) PaO2 in arterial blood gas; more than 60Torr or SpO2; more than 90% 8) Performance status (ECOG) of 0-2 9) Patients who provide written informed consent for entry of this trial
Exclusion criteria
Exclusion criteria: 1) Patients with active double cancers (simultaneous double cancers and metachronous double cancers with less than 5 years disease-free interval) Exclusion: carcinoma in situ of cervix, gastric and colorectal cancers which can be radically resected by endoscope, and locally-resectable skin cancer except malignant melanoma 2) Patients with apparent interstitial pneumonia or pulmonary fibrosis on chest computed tomography 3) Patients with symptomatic brain metastases Exclusion: patients who have had stable symptoms more than 2 weeks after radiation therapy or more than 4 weeks after surgery 4) Patients with active infection 5) Patients requring continuous oxgen therapy 6) Patients who are in pregnancy or intend to get pregnant 7) Patients with a history of serious drug allergy 8) Patients with other serious complications 9) Patients with a history of allergy for a component of afatinib 10) Patients who are considered to have difficulty in enrollment of this trial based on clinically important psychiatric reasons 11) Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survval | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Respose rate, and overall survival | — |
Countries
Japan
Contacts
Public ContactYasutaka Watanabe
Tokyo Medical University Hachioji Medical Center Department of Clinical Oncology
Outcome results
None listed