Non-Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-squamuous*, non-small cell lung cancer (NSCLC). *Cases with histological diagnosis of non-small cell lung cancer only, and /or cases with non-small cell lung cancer with less than 50% of squamous components will be applicable. 2) Stage IIIB/IV (UICC-7) or postoperative recurrence NSCLC 3) Patients who have previously treated with one or two chemotherapy regimen(s). Postoperative oral UFT therapy does not mean previous chemotherapy regimen. 4) Patients who have never received either epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) (EGFR-TKI) or pemetrexed. 5) Patients whose EGFR gene mutation in tumor cells is negative or unknown. 6) Patients who has at least one or more measurable lesion(s) by RECIST. 7) Performance status (ECOG) 0-2 8) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management. 9) Patients aged 20 years or older. 10) Sufficient function of main organ and bone marrow filling the following criteria: Neutrophil counts, 1,500/mm3 or over. Platelets, 100,000/mm3 or over. AST and ALT, x 2 of upper limit of normal (ULN) or less. Total bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. SpO2 90% or above. 11) Patients who are considered to survive for more than 3 months. 12) interval: (1) chemotherapy, more than 3 weeks after the last chemotherapy. (2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3) Operation, more than 3 weeks after the last operation (including pleurodesis) 13) Patients providing 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 who have previously treated with EGFR-TKI and / or pemetrexed 3) Patients with active severe infections 4) Impossible cases with oral administration 5) Patients with active opthalmological disease 6) Pregnancy or lactation 7) Patients with symptomatic brain metastasis 8) Patients with active concomitant malignancy 9) Patients with uncontrollable complications (e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea) 10) Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rseponse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, progression free survival, overall survival, evaluation of safety | — |
Countries
Japan
Contacts
Public ContactTetsuya Kubota
Kochi University, School of Medicine Department of Hematology and Respiratory Medicine
Outcome results
None listed