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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each).
Department of Medical Oncology, Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
Time frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
CTL response between HLA-A24:02 and non-HLA-A24:02
Time frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
PFS and ORR between HLA-A24:02 and non-HLA-A24:02
Time frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
PFS and OS between CTL response positive and negative
Time frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence
Time frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
Identification of biomarkers for efficacy and safety that are mentioned above
Time frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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