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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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-Salpêtriere 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vaxon Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Non-small Cell Lung Cancer Metastatic

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings