Overview

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

Status:
Unknown status
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shiga University
Collaborators:
Fukushima Medical University
Shionogi
Showa University
Tohoku University
Tokyo University
University of Chicago
Criteria
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 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.