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

Tokyo University

Status and phase: Unknown; Phase 2

Conditions: Non-small- Cell Lung Cancer

Treatments: Drug: S-588410; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02410369

IMS2643

UMIN000016979 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

S-588410

Active Comparator group

Description:

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

Treatment:

Drug: S-588410

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo