Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatment s-488410
Phase phase 2
Sponsor Shiga University
Collaborator Showa University
Start date May 2012
End date August 2015
Trial size 45 participants
Trial identifier NCT01592617, S488410LP, UMIN000007873

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
s-488410 S-488410 (S-488401, S-488402, S-488403).
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).

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 20 years up to 79 years old.

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 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.

Additional Information

Official title Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Principal investigator Yataro Daigo, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Shiga University.