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

Shiga University

Status and phase

Unknown

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: S-488410

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01592617

UMIN000007873 (Registry Identifier)

S488410LP

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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.