Efficacy Study of Vx001 Vaccine in NSCLC Patients

June 18, 2019 updated by: Vaxon Biotech

Phase II Study of Vx001 Vaccine in HLA-A*0201 Positive Patients With TERT Positive Stage IV or Recurrent Stage I-III NSCLC

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.

The objective of the trial is survival rate at 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Plzen-Bory, Czechia, 30599
        • Fakultni nemocnice Plzen
      • Praha 2, Czechia, 18008
        • Vseobecna Fakultní Nemocnice
  • France
      • Angers, France, 49933
        • University Hospital of Angers
      • Boulogne Billancourt, France, 92104
        • Ambroise Paré Hospital
      • Marseille, France, 13915
        • Hôpital Nord
      • Paris, France, 75651
        • Pitié-Salpêtrière Hospital
      • Rennes, France, 35033
        • Pontchaillou Hospital
  • Germany
      • Grosshansdorf, Germany, 22927
        • Hospital Grosshansdorf
      • Hemer, Germany, 58675
        • Lungenklinik Hemer
      • Kassel, Germany, 34125
        • Klinikum Kassel Gmbh
      • Kiel, Germany, 24116
        • University Medical Center Kiel
      • Löwenstein, Germany, 74245
        • Klinik Löwenstein
      • Mannheim, Germany, 68167
        • Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie
      • Minden, Germany, 32429
        • Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden
      • Munich, Germany, 80336
        • LMU Klinikum der Universität München
      • Oldenburg, Germany, 26121
        • Pius Hospital Oldenburg
      • Rheine, Germany, 48431
        • Mathias Spital Rheine Medizinische Klinik V
  • Greece
      • Alexandroupolis, Greece, 68100
        • University Hospital of Alexandroupolis
      • Athens, Greece, 11525
        • 251 General Airforce Hospital
      • Athens, Greece, 11527
        • General hospital of thoracic diseases Sotiria
      • Athens, Greece, 11528
        • Aretaieio Hospital
      • Athens, Greece, 11528
        • General Hospital Alexandra
      • Athens, Greece, 15562
        • Iaso General Hospital Cholargos
      • Heraklion, Greece, 71110
        • University Hospital of Heraklion
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina
      • Nea Kifissia, Greece, 14564
        • General Oncology Hospital of Kifissia Agioi Anargyroi
      • Rio, Greece, 26504
        • University Hospital of Patras
      • Thessaloniki, Greece, 56429
        • University General Hospital Papageorgiou
      • Thessaloniki, Greece, 57010
        • General Hospital G. Papanikolaou
  • Italy
      • Avellino, Italy, 83100
        • SG Moscati Hospital
      • Benevento, Italy, 82100
        • G. Rummo Hospital
      • Catanzaro, Italy, 88100
        • Mater Domini Catanzaro Hospital
      • Milan, Italy, 20141
        • European Institute of Oncology
      • Milano, Italy, 20142
        • San Paolo Hospital
      • Naples, Italy, 80131
        • Seconda Universita degli Studi Napoli Hospital
      • Padova, Italy, 35128
        • Insituto Oncologico Veneto
      • Perugia, Italy, 06132
        • S. Maria della Misericordia Hospital
      • Pisa, Italy, 56126
        • A.O.U di Pisa Hospital
      • Reggio Emilia, Italy, 42100
        • S. Maria Nuova Hospital
      • Siena, Italy, 53100
        • University Hospital of Siena
  • Poland
      • Bialystok, Poland, 15540
        • Uniwersytet Medyczny Bialistok
      • Gdansk, Poland, 80208
        • Hospicjum im. ks. T. Dutkiewicza SAC
      • Konin, Poland, 62500
        • Przychodnia KOMED
      • Krakow, Poland, 31108
        • NZOZ Vesalius
      • Lublin, Poland, 20064
        • MS Clinsearch
      • Olsztyn, Poland, 10357
        • Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc
      • Otwock, Poland, 05400
        • Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku
      • Poznan, Poland, 60693
        • Med-Polonia
      • Szczecin, Poland, 70891
        • Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego
      • Warszawa, Poland, 02781
        • Centrum Onkologii - Instytut im. M. Skłodowskiej - Curie
      • Warszawa, Poland, 02781
        • Fundacja Hospicjum Onkologiczne św. Krzysztofa
  • Romania
      • Baia Mare, Romania
        • SC Oncopremium Team SRL
      • Brăila, Romania
        • Spit. Jud. de Urgenţă
      • Bucuresti, Romania, 50098
        • Spitalul Universitar de Urgenta Bucuresti
      • Cluj-Napoca, Romania, 400058
        • Medisprof SRL
      • Cluj-Napoca, Romania, 400015
        • Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca
      • Craiova, Romania, 200385
        • Oncolab SRL
      • Sibiu, Romania, 550245
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Suceava, Romania
        • Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"
      • Timisoara, Romania
        • Oncomed SRL, Department of Medical Oncology
  • Spain
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08916
        • ICO-HOSPITAL GERMANS TRIAS I PUJOL
      • Barcelona, Spain, 08028
        • USP Institut Universitari Dexeus
      • Barcelona, Spain, 08035
        • University Hospital P. Vall d'Hebron
      • Castellón, Spain, 12002
        • Hospital Provencial de Castellón
      • Madrid, Spain, 28040
        • Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ
      • Madrid, Spain, 28222
        • Hospital Univesitario Puerta de Hierro
      • Málaga, Spain, 29010
        • H.R.U. Carlos Haya Málaga
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  1. Male or female ≥18 years of age;
  2. Documented stage IV NSCLC as defined by IASLC Lung Cancer Staging Project (7th edition) or recurrent stage I-III disease at least 6 months after resection or after the end of adjuvant chemotherapy or after standard locoregional treatment as defined by the American College of Chest Physicians;
  3. Patients treated with 4 cycles platinum based 1st line chemotherapy as defined by the American College of Chest Physicians (i.e. radiotherapy are not allowed except palliative radiotherapy of bone metastasis);
  4. Documented HLA-A*0201 positivity, as determined by a local laboratory;
  5. TERT-positive NSCLC, as assessed by a central laboratory; for this, availability of adequate tissue biopsy from the primary tumor, lymph nodes or distant metastases is a prerequisite;
  6. CR, PR, or SD according to RECIST 1.1 criteria after the completion of platinum-based first-line chemotherapy;
  7. ECOG performance status 0, 1;

Main Exclusion Criteria:

  1. Mixed small cell and NSCLC histologies;
  2. Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy;
  3. Prior treatment with cancer vaccines;
  4. Prior treatment with immunotherapy (e.g., interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization;
  5. Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization;
  6. Prior treatment with any investigational drugs, within 4 weeks prior to randomization;
  7. Patients with brain metastases;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Drug: Placebo
Experimental: Vx-001
Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Drug: Vx-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: 12 months
12 months
Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.
Time Frame: Traitement failure
Traitement failure

Other Outcome Measures

Outcome Measure
Time Frame
Comparison of vaccine induced immune responses between Vx-001 vs placebo in terms of frequency of TERT specific IFN-γ and perforin producing T cells in the blood of patients.
Time Frame: week 18
week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaxon Biotech

Investigators

  • Principal Investigator: Vassilis Georgoulias, MD,PhD, IASO general hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vx-001-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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