advanced non-small cell lung cancer
Conditions
Interventions
multicenter HLA-blinded open study: patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each)
Sponsors
Shiga University of Medical Science Hospital
Showa University Hospital, Fukushima Medical University Hospital, Tohoku University Hospital Shionogi &
Co., Ltd. The University of Tokyo, The University of Chicago
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Advanced NSCLC that cannot undergo curative surgery. 2.Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy. 3.Histologically diagnosed NSCLC. 4.Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment. 5.ECOG performance status 0-2 within 2 weeks prior to receiving treatment. 6.Life expectancy > 3 months. 7.Age between 20 to 79 8.Male or Female. 9.In patients or out patients. 10.Able and willing to give valid written informed consent.
Exclusion criteria
Exclusion criteria: 1.Other malignancy requiring treatment 2.Concurrent treatment with anticancer drug, steroids, immunosuppressing agent, radiation, immunotherapy, hyperthermia, or surgery. 3.Active and uncontrolled infectious disease 4.Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia). 5.Autoimmune disease. 6.HIV-Ab or antigen positive 7.Prior anti-cancer therapy within 4 weeks 8.Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value. 9.Patients knows HLA-A type. 10.Breastfeeding and Pregnancy (woman of child bearing potential) 11.Refusal of pregnancy conception. 12.Treated with S-488401, S-488402, or S-488403. 13.Treated with other investigational drug within 3 months prior to receiving S-48810 treatment. 14.Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of peptides specific CTL response rate between HLA-A 24:02 and non-HLA-A 24:02 patients. 2. Evaluation of clinical efficacy of S-488410: progression free survival and objective response rate between HLA-A 24:02 and non-HLA-A 24:02 patients. 3. Evaluation of clinical efficacy of S-488410: progression free survival and overall survival between CTL response positive and negative patients. 4. Evaluation of safety and tolerability of S-488410: adverse effects (disease, grade, and incidence). 5. Identification of biomarkers for efficacy and safety of S-488410. | — |
Countries
Japan
Contacts
Public ContactYataro Daigo MD, PhD
Shiga University of Medical Science Hospital Department of Medical Oncology
Outcome results
None listed