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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000016979 | Registry Identifier | UMIN |
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| Name | Class |
|---|---|
| Kanagawa Cancer Center | UNKNOWN |
| National Cancer Center Hospital East | OTHER |
| Shiga University of Medical Science | UNKNOWN |
| Fukushima Medical University |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-588410 | Active Comparator | Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410. |
|
| Placebo | Placebo Comparator | Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-588410 | Drug | Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival Time as a Measure of Efficacy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival Rate after Randomization as a Measure of Efficacy | 1 and 2 years | |
| Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yataro Daigo, MD, PhD | Contact | 03-5449-8111 | dctsm@ims.u-tokyo.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yataro Daigo, MD, PhD | Institute of Medical Science, The University of Tokyo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medical Science, The University of Tokyo | Recruiting | Tokyo | 108-8639 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18770861 | Background | 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. | |
| 17079454 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| OTHER |
| Hokkaido University | OTHER |
| Shionogi | INDUSTRY |
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| Placebo | Drug | Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of Placebo. |
|
| Overall Survival Time as a Measure of Efficacy | 4 years |
| Overall Survival Rate after Randomization as a Measure of Efficacy | 1 and 2 years |
| Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability | 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 | 4 years |
| Background |
| 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. |
| 25340007 | Background | 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. |
| 19459850 | Background | 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. |
| 18452554 | Background | 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. |
| 18089789 | Background | 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. |
| 17784873 | Background | 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. |
| 23657161 | Background | 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. |
| 18297458 | Background | 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |