Clinical trial NCT02470468: Evaluation of Safety and Efficacy of DCVAC/LuCa (Immunotherapy of Lung Cancer) in Patients With Metastatic Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage IV Non-small Cell Lung Cancer
Keywords: Immunotherapy
Metastatic
NSCLC
Biological
Lung Cancer
Vaccine
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of either adenomatous or squamous cell carcinoma differentiation; mixed tumors will be categorized by the predominant cell type.
2. Advanced NSCLC (stage IV unresectable disease)
3. Patients must have measurable or non-measurable disease
4. Patients (male and female) ≥ 18 years
5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 6. Patients must have recovered from toxicity of any prior therapy (e.g. surgery, radiotherapy, or therapy for other diseases than NSCLC). Recovery is defined as less than or equal to grade 2 toxicity according (except alopecia) to NCI CTCAE 7. Laboratory criteria 7.1 Platelet count of at least 100,000/mm3 (100 x 109/L) 7.2 White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L) 7.3 Hemoglobin (Hb) at least 9g/dL (90 g/L) 7.4 Total bilirubin levels ≤1.5mg/dL (benign hereditary hyper-bilirubinemias, e.g., Gilbert´s syndrome are permitted) 7.5 Serum alanine aminotransferase and aspartate aminotransferase ≤ 5 times the upper limit of normal (ULN) 7.6 Serum creatinine ≤ 1.5 times the upper limit of normal (ULN)

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:

1. Prior chemotherapy for stage IV NSCLC
2. Immunotherapy, monoclonal antibodies received within 4 weeks prior to randomization
3. Patients comorbidities 3.1 Patients who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (carboplatin/paclitaxel) 3.2 Active other malignancy than NSCLC 3.3 Known central nervous system (CNS) metastases 3.4 Any disease requiring chronic steroid or immunosuppressive therapy 3.5 HIV positive 3.6 Active hepatitis B (HBV) and/or C (HCV), active syphilis 3.7 Ongoing/active significant infection or other severe medical condition 3.8 Pre-existing thyroid disease unless it can be controlled with conventional treatment 3.9 Clinically significant cardiovascular disease including: 3.9.1 Uncontrolled congestive heart failure 3.9.2 Unstable angina pectoris 3.9.3 Uncontrolled severe cardiac arrhythmia 3.9.4 Myocardial infarction within 6 months prior randomization 3.10 Psychiatric illness/social situations that would limit compliance with study requirements
4. Pregnant or breast feeding women
5. Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
6. Contra indications to treatment with hydroxychloroquine, known G6PD deficiency (anamnestic information, no test necessary) and psoriasis

Primary outcomes:
measure: Comparison efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).
timeFrame: 17 months
Secondary outcomes:
measure: Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone. (AEs, SAEs, laboratory abnormalities, vital signs)
timeFrame: 17 months
measure: 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).
timeFrame: 17 months
measure: Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival.
timeFrame: 17 months
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Jindřichův Hradec
country: Czechia
city: Kutna Hora
country: Czechia
city: Nachod
country: Czechia
city: Olomouc
country: Czechia
city: Ostrava
country: Czechia
city: Pardubice
country: Czechia
city: Plzen
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Pribram
country: Czechia
city: Usti nad Labem
country: Czechia
city: Zlin
country: Czechia
city: Kosice
country: Slovakia
city: Piest'any
country: Slovakia
city: Poprad
country: Slovakia
Study officials:
affiliation: Sotio Biotech Inc.
name: Tomas Scheiner
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.