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

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: S-488410

• Registration Number: NCT01592617
• Lead Sponsor: Shiga University

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-488410	S-488410	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Medical Oncology, Shiga University of Medical Science Hospital; 🇯🇵 Otsu, Shiga, Japan