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

• ClinicalTrials.gov Identifier: NCT02470468
• Recruitment Status: Completed
• First Posted: June 12, 2015
• Last Update Posted: May 4, 2022
• Sponsor: SOTIO a.s.
• Information provided by (Responsible Party): SOTIO Biotech ( SOTIO a.s. )

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stage IV Non-small Cell Lung Cancer	Biological: DCVAC add on to SOC; Biological: DCVAC and immune enhancers add on to SOC; Other: Standard of Care Chemotherapy	Phase 1; Phase 2

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: November 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: DCVAC add on to SOC; Combination therapy with DCVAC and Standard of Care (Carboplatin, Paclitaxel)	Biological: DCVAC add on to SOC; DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
Experimental: DCVAC and immune enhancers add on to SOC; Combination therapy with DCVAC, immune enhancers (Interferon-α, Hydroxychloroquine) and Standard of Care (Carboplatin, Paclitaxel)	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
Standard of Care Chemotherapy; Standard of Care chemotherapy (Carboplatin, Paclitaxel)	Other: Standard of Care Chemotherapy; SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival. [ Time Frame: 17 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Czechia

Brno, Czechia, 625 00

Hradec Kralove, Czechia, 500 05

Jindřichův Hradec, Czechia, 377 38

Kutna Hora, Czechia, 284 01

Nachod, Czechia, 547 69

Olomouc, Czechia, 775 20

Ostrava, Czechia, 708 52

Pardubice, Czechia, 530 03

Plzen, Czechia, 305 99

Praha, Czechia, 128 08

Praha, Czechia, 140 59

Praha, Czechia, 150 06

Pribram, Czechia, 261 95

Usti nad Labem, Czechia, 401 13

Zlin, Czechia, 762 75

Slovakia

Kosice, Slovakia, 040 01

Piest'any, Slovakia, 921 01

Poprad, Slovakia, 058 01

Sponsors and Collaborators

SOTIO a.s.

Investigators

• Study Director: Tomas Scheiner; SOTIO Biotech

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: SOTIO a.s.
• ClinicalTrials.gov Identifier: NCT02470468
• Other Study ID Numbers: SLU01; 2014-003084-37 ( EudraCT Number )
• First Posted: June 12, 2015
• Last Update Posted: May 4, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by SOTIO Biotech ( SOTIO a.s. ):

Immunotherapy; Metastatic; NSCLC; Biological; Lung Cancer; Vaccine

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases