Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT02410369
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02410369
Study Brief:
Protocol Section:
NCT02410369