Non-small- Cell Lung CancerPhase 2NCT02410369

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

A Phase 2 study testing S-588410 in people with Non-small- Cell Lung Cancer, run by Tokyo University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Non-small- Cell Lung Cancer
What is being tested?: S-588410
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteJapan
Study dates: Mar 2015to Sep 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Yataro Daigo, MD, PhD contact

03-5449-8111

dctsm@ims.u-tokyo.ac.jp

Japan1 site, 1 recruiting

Institute of Medical Science, The University of Tokyo
Tokyo, 108-8639
Yataro Daigo, MD, PhD, 03-5449-8111, dctsm@ims.u-tokyo.ac.jp
Recruiting

Other trials in Japan

About this study

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

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.

Read the 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.

Conditions: Non-small- Cell Lung Cancer
Being tested: S-588410, Placebo
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02410369
Study group	Role	What they receive
S-588410	Active comparator	Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410. Receives: Drug: S-588410
Placebo	Placebo comparator	Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Relapse-free Survival Time as a Measure of Efficacy
Measured: 2 years

Secondary outcomes (6)

Relapse-free Survival Rate after Randomization as a Measure of Efficacy
Measured: 1 and 2 years
Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides
Measured: 2 years
Overall Survival Time as a Measure of Efficacy
Measured: 4 years
Overall Survival Rate after Randomization as a Measure of Efficacy
Measured: 1 and 2 years
Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability
Measured: 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
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Sep 2021

First posted7 Apr 2015 (estimated)
Study startMar 2015
Primary completionMar 2020 (estimated)
Study completionSep 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Non-small- Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02410369
Sponsor's protocol ID: IMS2643
Other IDs: UMIN000016979
Status last verified: Dec 2017
First submitted: 4 Mar 2015
Last updated: 21 Dec 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 18770861
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.
PubMed 17079454
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.
PubMed 25340007
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.
PubMed 19459850
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.
PubMed 18452554
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.
PubMed 18089789
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.
PubMed 17784873
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.
PubMed 23657161
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.
PubMed 18297458

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of S-588410 as Maintenance Monotherapy After Adjuvant Chemotherapy in Patients With Completely Resected Non-small- Cell Lung Cancer
ClinicalTrials.gov ID: NCT02410369
Acronym / sponsor ID: IMS2643
Conditions: Non-small- Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Tokyo UniversityUniversity, hospital or other
Collaborators: Kanagawa Cancer Center, National Cancer Center Hospital East, Shiga University of Medical Science, Fukushima Medical University, Hokkaido University, Shionogi
Study start: Mar 2015
Primary completion: Mar 2020 (estimated)
Study completion: Sep 2021 (estimated)
First posted: 7 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
S-588410	Active comparator	Drug: S-588410Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Placebo	Placebo comparator	Drug: PlaceboSubjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
S-588410Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.	Drug	S-588410
PlaceboFollowing randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of Placebo.	Drug	Placebo

Primary outcome

Relapse-free Survival Time as a Measure of Efficacy
Time frame: 2 years

6 secondary outcomes

Relapse-free Survival Rate after Randomization as a Measure of Efficacy
Time frame: 1 and 2 years
Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides
Time frame: 2 years
Overall Survival Time as a Measure of Efficacy
Time frame: 4 years
Overall Survival Rate after Randomization as a Measure of Efficacy
Time frame: 1 and 2 years
Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability
Time frame: 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
Time frame: 4 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
Background: PubMed 18770861Harao 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.
Background: PubMed 17079454Hayama 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.
Background: PubMed 25340007Tomita 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.
Background: PubMed 19459850Kono 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.
Background: PubMed 18452554Mizukami 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.
Background: PubMed 18089789Ishikawa 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.
Background: PubMed 17784873Suda 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.
Background: PubMed 23657161Daigo 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.
Background: PubMed 18297458Daigo 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yataro Daigo, MD, PhD contact

03-5449-8111

dctsm@ims.u-tokyo.ac.jp

Yataro Daigo, MD, PhD principal investigator

Institute of Medical Science, The University of Tokyo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-588410 in people with Non-small- Cell Lung Cancer, run by Tokyo University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yataro Daigo, MD, PhD (03-5449-8111, dctsm@ims.u-tokyo.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free Survival Time as a Measure of Efficacy (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02410369, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.