NCT02470468

Evaluation of Safety and Efficacy of DCVAC/LuCa (Immunotherapy of Lung Cancer) in Patients With Metastatic Lung Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: SOTIO a.s. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. Standard of Care chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).

Conditions

• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DCVAC add on to SOC	DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
BIOLOGICAL	DCVAC and immune enhancers add on to SOC	DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
OTHER	Standard of Care Chemotherapy	SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-01-01
• Completion: 2021-11-01
• First posted: 2015-06-12
• Last updated: 2022-05-04

Locations

18 sites across 2 countries: Czechia, Slovakia