Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
cancer vaccine, HLA-A*24:02, lung cancer, CTL
Brief 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.
Detailed 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.
Interventions
DRUGS-488410
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).
Sponsors
Showa University
Fukushima Medical University
Tohoku University
Shionogi
Tokyo University
University of Chicago
Shiga University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients. | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| CTL response between HLA-A24:02 and non-HLA-A24:02 | 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 | 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 | 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 | 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 | Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. |
Countries
Japan
Outcome results
None listed