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

NCT02410369 | Unknown Phase 2 DMC

• 2 other identifiers: IMS2643UMIN000016979
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small- Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Relapse-free Survival Time as a Measure of Efficacy

  2 years

Secondary Outcomes (6)

• 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

• 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

Study Arms (2)

S-588410

ACTIVE COMPARATOR

Subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410.

Drug: S-588410

Placebo

PLACEBO COMPARATOR

Subjects with HLA-A\*2402 in the placebo arm will receive the subcutaneous administration of placebo.

Drug: Placebo

Interventions

S-588410 DRUG

Following randomization, subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410.

S-588410

Placebo DRUG

Following randomization, subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of Placebo.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokyo University: lead
• Kanagawa Cancer Center: collaborator
• National Cancer Center Hospital East: collaborator
• Shiga University of Medical Science: collaborator
• Fukushima Medical University: collaborator
• Hokkaido University: collaborator
• Shionogi: collaborator

Study Sites (1)

Institute of Medical Science, The University of Tokyo

Tokyo, 108-8639, Japan

RECRUITING

Related Publications (9)

• 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.

  PMID: 18770861 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.

  PMID: 17079454 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.

  PMID: 25340007 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.

  PMID: 19459850 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.

  PMID: 18452554 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.

  PMID: 18089789 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.

  PMID: 17784873 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.

  PMID: 23657161 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.

  PMID: 18297458 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yataro Daigo, MD, PhD

  Institute of Medical Science, The University of Tokyo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yataro Daigo, MD, PhD

CONTACT

03-5449-8111; dctsm@ims.u-tokyo.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Professor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: April 7, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2021
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)