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

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ClinicalTrials.gov Identifier: NCT02410369
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : December 21, 2017
Sponsor:
Collaborators:
Kanagawa Cancer Center
National Cancer Center Hospital East
Shiga University of Medical Science
Fukushima Medical University
Hokkaido University
Shionogi
Information provided by (Responsible Party):
Yataro Daigo, Tokyo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small- Cell Lung Cancer Drug: S-588410 Drug: Placebo Phase 2

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.

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Study Type : Interventional
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of S-588410 as Maintenance Monotherapy After Adjuvant Chemotherapy in Patients With Completely Resected Non-small- Cell Lung Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Relapse-free Survival Time as a Measure of Efficacy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Relapse-free Survival Rate after Randomization as a Measure of Efficacy [ Time Frame: 1 and 2 years ]
  2. Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides [ Time Frame: 2 years ]
  3. Overall Survival Time as a Measure of Efficacy [ Time Frame: 4 years ]
  4. Overall Survival Rate after Randomization as a Measure of Efficacy [ Time Frame: 1 and 2 years ]
  5. Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 years ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410369


Contacts
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Contact: Yataro Daigo, MD, PhD 03-5449-8111 dctsm@ims.u-tokyo.ac.jp

Locations
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Japan
Institute of Medical Science, The University of Tokyo Recruiting
Tokyo, Japan, 108-8639
Contact: Yataro Daigo, MD, PhD    03-5449-8111    dctsm@ims.u-tokyo.ac.jp   
Sponsors and Collaborators
Tokyo University
Kanagawa Cancer Center
National Cancer Center Hospital East
Shiga University of Medical Science
Fukushima Medical University
Hokkaido University
Shionogi
Investigators
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Principal Investigator: Yataro Daigo, MD, PhD Institute of Medical Science, The University of Tokyo
Publications:

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Responsible Party: Yataro Daigo, Project Professor, Tokyo University
ClinicalTrials.gov Identifier: NCT02410369    
Other Study ID Numbers: IMS2643
UMIN000016979 ( Registry Identifier: UMIN )
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms