Non-small cell lung cancer
Conditions
Interventions
Sponsors
Central Japan Lung Study Group (CJLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically proven non-small cell lung cancer. 2) Patients with stage IIIB or IV who are not candidates for curative radiotherapy. 3) Patients having EGFR mutation (exon 19 deletion or L858R) by PNA-LNA PCR clamp method. 4) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.). 5) Patients who have previously treated one or two chemotherapy(prior chemotherapy consisting of platinum agents in at least one regimen). 6) Patient who has at least one or more measurable lesion by RECIST. 7) ECOG performance status (PS): 0-2 8) Patients who can be hospitalized for four weeks after beginning of the treatment or under management to apply to it. 9) Patients aged 20 years or older. 10) Adequate organ function. 11) Patients who are considered to survive for more than 3 months. 12) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.). 2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome. 4) Symptomatic brain metastasis. 5) Severe drug allergy. 6) Previous radiotherapy to primary lung cancer. 7) Patients who have previously treated three or more chemotherapy. 8) Patients who had a relapse after surgery. 9) With active double cancer. 10) Pregnancy or lactation. 11) Severe disorder of the eye. 12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rseponse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, Progression free survival, overall survival, Median survival time, 1-year survival rate, Evaluation of safety | — |
Countries
Japan
Contacts
Public ContactMasashi Kondo, Masahiro Morise, Tetsunari Hase
Nagoya University Graduate School of Medicine Department of Respiratory Medicine
Outcome results
None listed