Non-Small Cell Lung Cancer
Conditions
Interventions
a combined chemoimmunotherapy of Erlotinib plus WT1-W10 peptide vaccine
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-small cell lung cancer (NSCLC). 2) Stage IIIB/IV (UICC-7) or postoperative recurrent 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 not previously been treated with EGFR-TKI and / or WT1-W10 vaccine 5) Patients who have wild type EGFR gene or unknown status 6) Patients who have one of the following HLA types: A*24:02, A*02:01, A*02:06, A*02:07 7) Tumor tissues express WT1 antigen (if tissues are available) 8) Patients who has at least one or more measurable lesion(s) by RECIST. 9) Performance status (ECOG) 0-2 10) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management. 11) Patients aged 20 years or older. 12) 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, 1.5 mg/dl or less. Serum creatinin, x 1.5 of ULN or less. SpO2 90% or above (while breathing ambient air). 13) Patients who are considered to survive for more than 3 months. 14) Patients providing written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with active lung disease such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis, and considered as inappropriate for the study by the physicians 2) Patients with active severe infections 3) Impossible cases with oral administration 4) Patients with active severe opthalmological disease 5) Pregnancy or lactation 6) Patients with symptomatic brain metastasis 7) Patients with active concomitant malignancy 8) Patients with uncontrollable complications (e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea) 9) Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: recommended dose, evaluation of safety Phase II: response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: disease control rate, progression free survival, overall survival, evaluation of safety and specific immune response | — |
Countries
Japan
Contacts
Public ContactTetsuya Kubota
Kochi University, School of Medicine Department of Hematology and Respiratory Medicine
Outcome results
None listed