Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer

December 20, 2017 updated by: Yataro Daigo, Tokyo University

Phase II Study of S-588410 as Maintenance Monotherapy After Adjuvant Chemotherapy in Patients With Completely Resected Non-small- Cell Lung Cancer

In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in patients who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

In this phase II trial, the investigators evaluate the efficacy and safety of S-588410 containing oncoantigens-derived HLA-A*2402-restricted epitope peptides in patients with HLA-A*2402 who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

      • Tokyo, Japan, 108-8639
        • Recruiting
        • Institute of Medical Science, The University of Tokyo
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
  2. Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
  3. Patients with HLA-A*24:02.
  4. Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
  5. Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
  6. ECOG performance status 0 or 1 within 2 weeks prior to the registration.
  7. Age over 20 years at time of consent acquisition.
  8. The written informed consent provided by the patient.

Exclusion Criteria:

  1. Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
  2. Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
  3. Active and uncontrolled infectious disease.
  4. Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
  5. Coronary artery stenting within 6 months prior to registration.
  6. Autoimmune disease.
  7. HIV infection.
  8. Registration within 4 weeks after the last adjuvant chemotherapy.
  9. Laboratory values defined in the protocol within 2 weeks prior to registration.
  10. Residual uncontrolled adverse events by adjuvant chemotherapy.
  11. Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
  12. Past history of severe allergic reaction against drug, vaccine and biological agents.
  13. Female patient in nursing or pregnancy.
  14. Refusal of pregnancy conception.
  15. Treated with the same peptide vaccines as S-588410.
  16. Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
  17. Decision of non-enrollment 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: S-588410
Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Placebo Comparator: Placebo
Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo.
Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free Survival Time as a Measure of Efficacy
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse-free Survival Rate after Randomization as a Measure of Efficacy
Time Frame: 1 and 2 years
1 and 2 years
Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides
Time Frame: 2 years
2 years
Overall Survival Time as a Measure of Efficacy
Time Frame: 4 years
4 years
Overall Survival Rate after Randomization as a Measure of Efficacy
Time Frame: 1 and 2 years
1 and 2 years
Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability
Time Frame: 4 years
4 years
Association between Overall Survival Time as a Measure of Efficacy and Gene Variation detected by Genomics Methods in Lymphocytes as a Predictive Biomarker
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yataro Daigo, MD, PhD, Institute of Medical Science, The University of Tokyo

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

March 1, 2015

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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