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

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ClinicalTrials.gov Identifier: NCT02470468
Recruitment Status : Unknown
Verified November 2016 by Sotio a.s..
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

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 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
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470468


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 a.s.

Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT02470468     History of Changes
Other Study ID Numbers: SLU01
2014-003084-37 ( EudraCT Number )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sotio a.s.:
Immunotherapy
Metastatic
NSCLC
Biological
Lung Cancer
Vaccine

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Interferons
Hydroxychloroquine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Antirheumatic Agents