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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Non-small- Cell Lung Cancer

Intervention / Treatment
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* Drug: S-588410
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S-588410<br>Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410. | Drug: S-588410<br>* Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.<br>|
| Placebo Comparator: Placebo<br>Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo. | Drug: Placebo<br>* Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free Survival Time as a Measure of Efficacy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |