Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer

Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer

The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.

The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Inclusion Criteria:

• Advanced NSCLC that cannot undergo curative surgery.
• Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
• Histologically diagnosed NSCLC.
• Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
• ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
• Life expectancy > 3 months.
• Age between 20 to 79
• Male or Female.
• In patients or out patients.
• Able and willing to give valid written informed consent.

Exclusion Criteria:

• Other malignancy requiring treatment
• radiation, immunotherapy, hyperthermia, or surgery.
• Active and uncontrolled infectious disease
• Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
• Autoimmune disease.
• HIV-Ab or antigen positive
• Prior anti-cancer therapy within 4 weeks
• 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.
• Patients knows HLA-A type.
• Breastfeeding and Pregnancy (woman of child bearing potential)
• Refusal of pregnancy conception.
• Treated with S-488401, S-488402, or S-488403.
• Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
• Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.