Clinical trial · Interventional
Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer
Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
NCT01592617CI-TRIAL-00018817unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-488410 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-488410
- interventionNames
- Drug: S-488410
Primary outcomes (1)
- measure
- Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
- timeFrame
- Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
Secondary outcomes (5)
- measure
- CTL response between HLA-A24:02 and non-HLA-A24:02
- timeFrame
- Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
- measure
- PFS and ORR between HLA-A24:02 and non-HLA-A24:02
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced NSCLC that cannot undergo curative surgery. * Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy. * Histologically diagnosed NSCLC. * Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment. * ECOG performance status 0-2 within 2 weeks prior to receiving treatment. * Life expectancy \> 3 months. * Age between 20 to 79 * Male or Female. * In patients or out patients. * Able and willing to give valid written informed consent. Exclusion Criteria: * Other malignancy requiring treatment * radiation, immunotherapy, hyperthermia, or surgery. * Active and uncontrolled infectious disease * Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia). * Autoimmune disease. * HIV-Ab or antigen positive * Prior anti-cancer therapy within 4 weeks * Laboratory values as follows: 2000\<mm3 \< WBC \< 15000/mm3, Platelet count \< 50000/mm3, Asparate transaminase \> 5 X cutoff value, Alanine transaminase \> 5 X cutoff value, Total bilirubin \> 3 X cutoff value, and Serum creatinine \> 3X cutoff value. * Patients knows HLA-A type. * Breastfeeding and Pregnancy (woman of child bearing potential) * Refusal of pregnancy conception. * Treated with S-488401, S-488402, or S-488403. * Treated with other investigational drug within 3 months prior to receiving S-48810 treatment. * Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
References
Publications (7)
- BACKGROUNDKono 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. PMID 19459850
- BACKGROUNDHarao 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. PMID 18770861
- BACKGROUNDMizukami 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. PMID 18452554
- BACKGROUNDDaigo 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. PMID 18297458
- BACKGROUNDIshikawa 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. PMID 18089789
- BACKGROUNDSuda 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.