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Safety & Efficacy Study of EGF Cancer Vaccine to Treat Stage IV Biomarker Positive, Wild Type EGF-R NSCLC Patients

NCT02187367 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-09-10

No results posted yet for this study

Summary

The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

EGF Vaccine

1.2mL of conjugate-adjuvant mix injection at four sites during the Post First-Line Chemotherapy. Reduced dose of injection at two sites during the Pre-Progression Phase.

Sponsors & Collaborators

  • Bioven Europe

    lead INDUSTRY

Principal Investigators

  • Libor Havel, Dr. · Thomayerova nemocnice, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-05-01
Completion
2019-09-06

Countries

  • Bulgaria
  • Czechia
  • Georgia
  • Germany
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Spain
  • Thailand
  • United Kingdom

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 NCT02187367 on ClinicalTrials.gov