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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003084-37 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCVAC add on to SOC | Experimental | Combination therapy with DCVAC and Standard of Care (Carboplatin, Paclitaxel) |
|
| DCVAC and immune enhancers add on to SOC | Experimental | Combination therapy with DCVAC, immune enhancers (Interferon-α, Hydroxychloroquine) and Standard of Care (Carboplatin, Paclitaxel) |
|
| Standard of Care Chemotherapy | Other | Standard of Care chemotherapy (Carboplatin, Paclitaxel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCVAC add on to SOC | Biological | DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone. (AEs, SAEs, laboratory abnormalities, vital signs) | 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). |
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Inclusion Criteria:
8. Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the treatment plus 3 months.
9. Signed informed consent including patient's ability to comprehend its contents. (Consent to genetic testing is not a condition for participation in the clinical trial)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Scheiner | Sotio Biotech Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | 625 00 | Czechia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35898703 | Derived | Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022. | |
| 31931024 |
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| DCVAC and immune enhancers add on to SOC | Biological | DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death |
|
| Standard of Care Chemotherapy | Other | SOC (Carboplatin, Paclitaxel): until progression or intolerance or death |
|
| 17 months |
| Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival. | 17 months |
| Hradec Králové |
| 500 05 |
| Czechia |
| Jindřichův Hradec | 377 38 | Czechia |
| Kutná Hora | 284 01 | Czechia |
| Náchod | 547 69 | Czechia |
| Olomouc | 775 20 | Czechia |
| Ostrava | 708 52 | Czechia |
| Pardubice | 530 03 | Czechia |
| Pilsen | 305 99 | Czechia |
| Prague | 128 08 | Czechia |
| Prague | 140 59 | Czechia |
| Prague | 150 06 | Czechia |
| Příbram | 261 95 | Czechia |
| Ústí nad Labem | 401 13 | Czechia |
| Zlín | 762 75 | Czechia |
| Košice | 040 01 | Slovakia |
| Piešťany | 921 01 | Slovakia |
| Poprad | 058 01 | Slovakia |
| Derived |
| Palata O, Podzimkova Hradilova N, Mysikova D, Kutna B, Mrazkova H, Lischke R, Spisek R, Adkins I. Detection of tumor antigens and tumor-antigen specific T cells in NSCLC patients: Correlation of the quality of T cell responses with NSCLC subtype. Immunol Lett. 2020 Mar;219:46-53. doi: 10.1016/j.imlet.2020.01.001. Epub 2020 Jan 10. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C049705 | S-1,2-dichlorovinyl-N-acetylcysteine |
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