- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02410369
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
Conditions
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
- Name: Yataro Daigo, MD, PhD
- Phone Number: 03-5449-8111
- Email: dctsm@ims.u-tokyo.ac.jp
Study Locations
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-
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Tokyo, Japan, 108-8639
- Recruiting
- Institute of Medical Science, The University of Tokyo
-
Contact:
- Yataro Daigo, MD, PhD
- Phone Number: 03-5449-8111
- Email: dctsm@ims.u-tokyo.ac.jp
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-
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:
- Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
- Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
- Patients with HLA-A*24:02.
- Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
- Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
- ECOG performance status 0 or 1 within 2 weeks prior to the registration.
- Age over 20 years at time of consent acquisition.
- The written informed consent provided by the patient.
Exclusion Criteria:
- Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
- Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
- Active and uncontrolled infectious disease.
- Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
- Coronary artery stenting within 6 months prior to registration.
- Autoimmune disease.
- HIV infection.
- Registration within 4 weeks after the last adjuvant chemotherapy.
- Laboratory values defined in the protocol within 2 weeks prior to registration.
- Residual uncontrolled adverse events by adjuvant chemotherapy.
- Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
- Past history of severe allergic reaction against drug, vaccine and biological agents.
- Female patient in nursing or pregnancy.
- Refusal of pregnancy conception.
- Treated with the same peptide vaccines as S-588410.
- Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
- 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.
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Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
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Placebo Comparator: Placebo
Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo.
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Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of Placebo.
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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
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse-free Survival Rate after Randomization as a Measure of Efficacy
Time Frame: 1 and 2 years
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1 and 2 years
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Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides
Time Frame: 2 years
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2 years
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Overall Survival Time as a Measure of Efficacy
Time Frame: 4 years
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4 years
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Overall Survival Rate after Randomization as a Measure of Efficacy
Time Frame: 1 and 2 years
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1 and 2 years
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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
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4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.
- Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30.
- Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.
- Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.
- Harao M, Hirata S, Irie A, Senju S, Nakatsura T, Komori H, Ikuta Y, Yokomine K, Imai K, Inoue M, Harada K, Mori T, Tsunoda T, Nakatsuru S, Daigo Y, Nomori H, Nakamura Y, Baba H, Nishimura Y. HLA-A2-restricted CTL epitopes of a novel lung cancer-associated cancer testis antigen, cell division cycle associated 1, can induce tumor-reactive CTL. Int J Cancer. 2008 Dec 1;123(11):2616-25. doi: 10.1002/ijc.23823.
- Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24.
- Hayama S, Daigo Y, Kato T, Ishikawa N, Yamabuki T, Miyamoto M, Ito T, Tsuchiya E, Kondo S, Nakamura Y. Activation of CDCA1-KNTC2, members of centromere protein complex, involved in pulmonary carcinogenesis. Cancer Res. 2006 Nov 1;66(21):10339-48. doi: 10.1158/0008-5472.CAN-06-2137.
- Tomita Y, Yuno A, Tsukamoto H, Senju S, Kuroda Y, Hirayama M, Imamura Y, Yatsuda J, Sayem MA, Irie A, Hamada A, Jono H, Yoshida K, Tsunoda T, Daigo Y, Kohrogi H, Yoshitake Y, Nakamura Y, Shinohara M, Nishimura Y. Identification of immunogenic LY6K long peptide encompassing both CD4+ and CD8+ T-cell epitopes and eliciting CD4+ T-cell immunity in patients with malignant disease. Oncoimmunology. 2014 Mar 27;3:e28100. doi: 10.4161/onci.28100. eCollection 2014.
- Daigo Y, Takano A, Teramoto K, Chung S, Nakamura Y. A systematic approach to the development of novel therapeutics for lung cancer using genomic analyses. Clin Pharmacol Ther. 2013 Aug;94(2):218-23. doi: 10.1038/clpt.2013.90. Epub 2013 May 8.
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
Additional Relevant MeSH Terms
Other Study ID 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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