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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
Unnamed facility
Brno, Czechia
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Jindřichův Hradec, Czechia
Comparison efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).
Time frame: 17 months
Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone. (AEs, SAEs, laboratory abnormalities, vital signs)
Time frame: 17 months
Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by objective response rate and duration of response (per RECIST 1.1).
Time frame: 17 months
Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival.
Time frame: 17 months
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Unnamed facility
Kutná Hora, Czechia
Unnamed facility
Náchod, Czechia
Unnamed facility
Olomouc, Czechia
Unnamed facility
Ostrava, Czechia
Unnamed facility
Pardubice, Czechia
Unnamed facility
Pilsen, Czechia
Unnamed facility
Prague, Czechia
...and 8 more locations