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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

S-488410

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring cancer vaccine, HLA-A*24:02, lung cancer, CTL

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Medical Oncology, Shiga University of Medical Science Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-488410

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.

Secondary Outcome Measures

CTL response between HLA-A24:02 and non-HLA-A24:02

PFS and ORR between HLA-A24:02 and non-HLA-A24:02

PFS and OS between CTL response positive and negative

Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence

Identification of biomarkers for efficacy and safety that are mentioned above

Full Information

NCT ID

NCT01592617

First Posted

May 2, 2012

Last Updated

August 11, 2015

Sponsor

Shiga University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01592617

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiga University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

cancer vaccine, HLA-A*24:02, lung cancer, CTL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-488410

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

S-488410

Other Intervention Name(s)

S-488410 (S-488401, S-488402, S-488403).

Intervention Description

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 Outcome Measure Information:

Title

Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.

Time Frame