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

NCT ID: NCT02470468

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-11-30

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).

Conditions

Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCVAC add on to SOC

Combination therapy with DCVAC and Standard of Care (Carboplatin, Paclitaxel)

Group Type: EXPERIMENTAL

DCVAC add on to SOC

Intervention Type: BIOLOGICAL

DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

DCVAC and immune enhancers add on to SOC

Combination therapy with DCVAC, immune enhancers (Interferon-α, Hydroxychloroquine) and Standard of Care (Carboplatin, Paclitaxel)

Group Type: EXPERIMENTAL

DCVAC and immune enhancers add on to SOC

Intervention Type: BIOLOGICAL

DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Standard of Care Chemotherapy

Standard of Care chemotherapy (Carboplatin, Paclitaxel)

Group Type: OTHER

Standard of Care Chemotherapy

Intervention Type: OTHER

SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Interventions

DCVAC add on to SOC

DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Intervention Type: 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

Intervention Type: BIOLOGICAL

Standard of Care Chemotherapy

SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOTIO a.s.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomas Scheiner

Role: STUDY_DIRECTOR

Sotio Biotech Inc.

Locations

Brno, , Czechia

Hradec Králové, , Czechia

Jindřichův Hradec, , Czechia

Kutná Hora, , Czechia

Náchod, , Czechia

Olomouc, , Czechia

Ostrava, , Czechia

Pardubice, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Příbram, , Czechia

Ústí nad Labem, , Czechia

Zlín, , Czechia

Košice, , Slovakia

Piešťany, , Slovakia

Poprad, , Slovakia

Countries

Czechia; Slovakia

References

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.

Reference Type: DERIVED

PMID: 35898703 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31931024 (View on PubMed)

Other Identifiers

2014-003084-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SLU01

Identifier Type: -

Identifier Source: org_study_id