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A Phase I/II Study to Evaluate Safety and Efficacy of DCVAC/LuCa Added to Standard First Line ChT With Carboplatin and Paclitaxel +/- Immune Enhancers (Interferon-α and Hydroxychloroquine) vs ChT Alone in Patients With Stage IV NSCLC
The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).
Details
| Lead sponsor | SOTIO a.s. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 105 |
| Start date | 2014-12 |
| Completion | 2021-11 |
Conditions
- Stage IV Non-small Cell Lung Cancer
Interventions
- DCVAC add on to SOC
- DCVAC and immune enhancers add on to SOC
- Standard of Care Chemotherapy
Primary outcomes
- Comparison efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS). — 17 months
Countries
Czechia, Slovakia