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

Primary Purpose

Non-small- Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

S-588410

Placebo

About this trial

This is an interventional treatment trial for Non-small- Cell Lung Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institute of Medical Science, The University of TokyoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

S-588410

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Relapse-free Survival Time as a Measure of Efficacy

Secondary Outcome Measures

Relapse-free Survival Rate after Randomization as a Measure of Efficacy

Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides

Overall Survival Time as a Measure of Efficacy

Overall Survival Rate after Randomization as a Measure of Efficacy

Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability

Association between Overall Survival Time as a Measure of Efficacy and Gene Variation detected by Genomics Methods in Lymphocytes as a Predictive Biomarker

Full Information

NCT ID

NCT02410369

First Posted

March 4, 2015

Last Updated

December 20, 2017

Sponsor

Tokyo University

Collaborators

Kanagawa Cancer Center, National Cancer Center Hospital East, Shiga University of Medical Science, Fukushima Medical University, Hokkaido University, Shionogi

1. Study Identification

Unique Protocol Identification Number

NCT02410369

Brief Title

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

Official Title

Phase II Study of S-588410 as Maintenance Monotherapy After Adjuvant Chemotherapy in Patients With Completely Resected Non-small- Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tokyo University

Collaborators

Kanagawa Cancer Center, National Cancer Center Hospital East, Shiga University of Medical Science, Fukushima Medical University, Hokkaido University, Shionogi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small- Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-588410

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

S-588410

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Relapse-free Survival Time as a Measure of Efficacy

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Relapse-free Survival Rate after Randomization as a Measure of Efficacy

Time Frame

1 and 2 years

Title

Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides

Time Frame

2 years

Title

Overall Survival Time as a Measure of Efficacy

Time Frame

4 years

Title

Overall Survival Rate after Randomization as a Measure of Efficacy

Time Frame

1 and 2 years

Title

Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability

Time Frame

4 years

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yataro Daigo, MD, PhD

Phone

03-5449-8111

dctsm@ims.u-tokyo.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yataro Daigo, MD, PhD

Organizational Affiliation

Institute of Medical Science, The University of Tokyo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Medical Science, The University of Tokyo

City

Tokyo

ZIP/Postal Code

108-8639

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yataro Daigo, MD, PhD

Phone

03-5449-8111

dctsm@ims.u-tokyo.ac.jp

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18770861

Citation

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.

Results Reference

background

PubMed Identifier

17079454

Citation

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.

Results Reference

background

PubMed Identifier

25340007

Citation

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.

Results Reference

background

PubMed Identifier

19459850

Citation

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.

Results Reference

background

PubMed Identifier

18452554

Citation

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.

Results Reference

background

PubMed Identifier

18089789

Citation

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.

Results Reference

background

PubMed Identifier

17784873

Citation

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.

Results Reference

background

PubMed Identifier

23657161

Citation

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.

Results Reference

background

PubMed Identifier

18297458

Citation

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.

Results Reference

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

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