Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer
NCT ID: NCT02410369
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2015-03-31
2021-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
S-588410
Subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
S-588410
Following randomization, subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Placebo
Subjects with HLA-A\*2402 in the placebo arm will receive the subcutaneous administration of placebo.
Placebo
Following randomization, subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of Placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
S-588410
Following randomization, subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Placebo
Following randomization, subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of Placebo.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kanagawa Cancer Center
UNKNOWN
National Cancer Center Hospital East
OTHER
Shiga University of Medical Science
UNKNOWN
Fukushima Medical University
OTHER
Hokkaido University
OTHER
Shionogi
INDUSTRY
Tokyo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yataro Daigo
Project Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yataro Daigo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Medical Science, The University of Tokyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Medical Science, The University of Tokyo
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yataro Daigo, MD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UMIN000016979
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMS2643
Identifier Type: -
Identifier Source: org_study_id