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

NCT02470468 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-05-04

No results posted yet for this study

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).

Conditions

  • Stage IV Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

DCVAC add on to SOC

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

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

OTHER

Standard of Care Chemotherapy

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

Sponsors & Collaborators

  • SOTIO a.s.

    lead INDUSTRY

Principal Investigators

  • Tomas Scheiner · Sotio Biotech Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-01-31
Completion
2021-11-30

Countries

  • Czechia
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470468 on ClinicalTrials.gov