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

Phase 2
20 Years
79 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

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 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

- Decision of nonenrollment of the patients by principal investigator or
physician-in-charge from the view point of patient's safety.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.

Outcome Time Frame:

Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.

Safety Issue:


Principal Investigator

Yataro Daigo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medical Oncology, Shiga University of Medical Science


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

May 2012

Completion Date:

June 2015

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • cancer vaccine
  • HLA-A*24:02
  • lung cancer
  • CTL
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms