NCT02470468

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_1

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

June 3, 2015

Last Update Submit

May 3, 2022

Conditions

Stage IV Non-small Cell Lung Cancer

Keywords

ImmunotherapyMetastaticNSCLCBiologicalLung CancerVaccine

Outcome Measures

Primary Outcomes (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).

    17 months

Secondary Outcomes (3)

  • 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).

    17 months

  • Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival.

    17 months

Study Arms (3)

DCVAC add on to SOC

EXPERIMENTAL

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

Biological: DCVAC add on to SOC

DCVAC and immune enhancers add on to SOC

EXPERIMENTAL

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

Biological: DCVAC and immune enhancers add on to SOC

Standard of Care Chemotherapy

OTHER

Standard of Care chemotherapy (Carboplatin, Paclitaxel)

Other: Standard of Care Chemotherapy

Interventions

DCVAC add on to SOCBIOLOGICAL

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

DCVAC add on to SOC
DCVAC and immune enhancers add on to SOCBIOLOGICAL

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

DCVAC and immune enhancers add on to SOC
Standard of Care ChemotherapyOTHER

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

Standard of Care Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Advanced NSCLC (stage IV unresectable disease)
  • Patients must have measurable or non-measurable disease
  • Patients (male and female) ≥ 18 years
  • 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)
  • \. 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.
  • \. 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)

You may not qualify if:

  • Prior chemotherapy for stage IV NSCLC
  • Immunotherapy, monoclonal antibodies received within 4 weeks prior to randomization
  • 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
  • Pregnant or breast feeding women
  • Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
  • Contra indications to treatment with hydroxychloroquine, known G6PD deficiency (anamnestic information, no test necessary) and psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Brno, 625 00, Czechia

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Jindřichův Hradec, 377 38, Czechia

Location

Unknown Facility

Kutná Hora, 284 01, Czechia

Location

Unknown Facility

Náchod, 547 69, Czechia

Location

Unknown Facility

Olomouc, 775 20, Czechia

Location

Unknown Facility

Ostrava, 708 52, Czechia

Location

Unknown Facility

Pardubice, 530 03, Czechia

Location

Unknown Facility

Pilsen, 305 99, Czechia

Location

Unknown Facility

Prague, 128 08, Czechia

Location

Unknown Facility

Prague, 140 59, Czechia

Location

Unknown Facility

Prague, 150 06, Czechia

Location

Unknown Facility

Příbram, 261 95, Czechia

Location

Unknown Facility

Ústí nad Labem, 401 13, Czechia

Location

Unknown Facility

Zlín, 762 75, Czechia

Location

Unknown Facility

Košice, 040 01, Slovakia

Location

Unknown Facility

Piešťany, 921 01, Slovakia

Location

Unknown Facility

Poprad, 058 01, Slovakia

Location

Related Publications (2)

  • 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.

    PMID: 35898703DERIVED

  • 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.

    PMID: 31931024DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm MetastasisLung Neoplasms

Interventions

S-1,2-dichlorovinyl-N-acetylcysteine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tomas Scheiner

    Sotio Biotech Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 12, 2015

Study Start

December 1, 2014

Primary Completion

January 1, 2018

Study Completion

November 1, 2021

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

SL(3)CZ(15)