Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
IMS2643
- SECONDARY ID:
UMIN000016979
- NCT ID:
NCT02410369
Conditions
- Non-small- Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
S-588410 | | S-588410 |
Placebo | | Placebo |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
S-588410 | Active Comparator | Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410. | |
Placebo | Placebo Comparator | Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo. | |
Eligibility Criteria
Inclusion Criteria:
1. Patients who received platinum-based adjuvant chemotherapy after the complete
resection of lung cancer.
2. Pathologically determined non-small-cell lung cancer excepting the large cell
neuroendocrine carcinoma and mixed type.
3. Patients with HLA-A*24:02.
4. Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by
imaging tests within 6 weeks prior to the registration.
5. Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
6. ECOG performance status 0 or 1 within 2 weeks prior to the registration.
7. Age over 20 years at time of consent acquisition.
8. The written informed consent provided by the patient.
Exclusion Criteria:
1. Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
2. Concurrent treatment with anticancer drug, steroids, immunosuppressive agent,
radiotherapy, immunotherapy, hyperthermia, or surgery.
3. Active and uncontrolled infectious disease.
4. Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease,
hematological disorder, or metabolic disease.
5. Coronary artery stenting within 6 months prior to registration.
6. Autoimmune disease.
7. HIV infection.
8. Registration within 4 weeks after the last adjuvant chemotherapy.
9. Laboratory values defined in the protocol within 2 weeks prior to registration.
10. Residual uncontrolled adverse events by adjuvant chemotherapy.
11. Eosinophilia within 28 days prior to registration. Past or active eosinophilic
pneumonia or interstitial pneumonitis.
12. Past history of severe allergic reaction against drug, vaccine and biological agents.
13. Female patient in nursing or pregnancy.
14. Refusal of pregnancy conception.
15. Treated with the same peptide vaccines as S-588410.
16. Treated with another investigational drug within 28 days prior to registration or the
period of 5 times of the drug half-life.
17. Decision of non-enrollment of the patients by principal investigator or
physician-in-charge from the view point of patient's safety.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Relapse-free Survival Time as a Measure of Efficacy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Relapse-free Survival Rate after Randomization as a Measure of Efficacy |
Time Frame: | 1 and 2 years |
Safety Issue: | |
Description: | |
Measure: | Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival Time as a Measure of Efficacy |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival Rate after Randomization as a Measure of Efficacy |
Time Frame: | 1 and 2 years |
Safety Issue: | |
Description: | |
Measure: | Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tokyo University |
Last Updated
December 21, 2017