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

August 11, 2015 updated by: Yataro Daigo, Shiga University

Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Department of Medical Oncology, Shiga University of Medical Science Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-488410
Drug: S-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).
Other Names:
  • S-488410 (S-488401, S-488402, S-488403).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.
Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiga University

Collaborators

University of Chicago
Shionogi
Tokyo University
Showa University
Fukushima Medical University
Tohoku University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S488410LP
  • UMIN000007873 (Registry Identifier: UMIN: University Hospital Medical Information Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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