relapsed non-small-cell lung cancer
Conditions
Interventions
Sponsors
Okayama Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pathologically proven NSCLC Patients with targeted lesions defined in the RECIST guideline Patients previously treated with 1 to 3 chemotherapy regimens Those without any active EGFR mutations in the tumor specimens Those with no prior therapy within four weeks Those with ECOG PS of 0 to 2 Those considered to survive for more than two months Those with adequate organ functions Those providing written informed consent
Exclusion criteria
Exclusion criteria: Patients without adequate tumor samples for assessing EGFR mutation status Those with severe co-morbidity including uncontrollable cardiac, cerebral and infectious disease and diabetes mellitus Those with symptomatic cerebral metastasis Those with active interstitial pneumonia or massive malignant pleural/pericardial effusion Pregnant or lactating women Those previously treated with EGFR-tyrosine kinase inhibitors Those who need to be treated immediately with radiotherapy Patients judged as being in inappropriate condition for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-tumor activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, overall survival, progression-free survival, questionnaire about participation in this study, and molecular analysis using tumor samples (MET gene amplification, PTEN expression, K-ras gene mutation, methylation anlaysis for serum MGMT, RARB, p16, DAPK, RASSF1A, and EGFR) | — |
Countries
Japan
Outcome results
None listed