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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: S-588410
Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Drug: 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.
Drug: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Relapse-free Survival Time as a Measure of Efficacy
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokyo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shionogi
National Cancer Center Hospital East
Hokkaido University
Fukushima Medical University
Kanagawa Cancer Center
Shiga University of Medical Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMS2643
  • UMIN000016979 (Registry Identifier: UMIN)

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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