Non-small cell lung cancer
Conditions
Interventions
None listed
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 who are not candidates for curative radiotherapy. 3) Patients with EGFR wild type or EGFR mutation (exon 19 deletion or exon 21 L858R) *Gene analysis 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 |
|---|---|
| To investigate the correlation between the serum marker analysis and the clinical data such as response rate, disease control rate, overall survival and progression free survival for previously treated NSCLC patients with and without EGFR Mutation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To acquire the additional information on possible correlation between serum marker analysis and EGFR mutation status in previously treated NSCLC patients. | — |
Countries
Japan
Contacts
Public ContactMasashi Kondo, Masahiro Morisse, Tetsunari Hase
Nagoya University Graduate School of Medicine Department of Respiratory Medicine
Outcome results
None listed