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AzTrials

Non-small Cell Lung Cancer MetastaticPhase 2NCT01935154

Efficacy Study of Vx001 Vaccine in NSCLC Patients

A Phase 2 study testing Vx-001 in people with Non-small Cell Lung Cancer Metastatic, run by Vaxon Biotech at 70 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
Vx-001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
70 sitesin 8 countries
Study dates
Aug 2012to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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;

Trial locations and contacts

70 sites in 8 countries.

70 sites in 8 countries

Greece12 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • 251 General Airforce Hospital

    Athens, 11525

  • General hospital of thoracic diseases Sotiria

    Athens, 11527

  • Aretaieio Hospital

    Athens, 11528

  • General Hospital Alexandra

    Athens, 11528

  • Iaso General Hospital Cholargos

    Athens, 15562

  • University Hospital of Heraklion

    Heraklion, 71110

  • University General Hospital of Ioannina

    Ioannina, 45500

  • General Oncology Hospital of Kifissia Agioi Anargyroi

    Nea Kifissia, 14564

  • University Hospital of Patras

    Rio, 26504

  • University General Hospital Papageorgiou

    Thessaloniki, 56429

  • General Hospital G. Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

Italy11 sites

  • SG Moscati Hospital

    Avellino, 83100

  • G. Rummo Hospital

    Benevento, 82100

  • Mater Domini Catanzaro Hospital

    Catanzaro, 88100

  • European Institute of Oncology

    Milan, 20141

  • San Paolo Hospital

    Milan, 20142

  • Seconda Universita degli Studi Napoli Hospital

    Naples, 80131

  • Insituto Oncologico Veneto

    Padova, 35128

  • S. Maria della Misericordia Hospital

    Perugia, 06132

  • A.O.U di Pisa Hospital

    Pisa, 56126

  • S. Maria Nuova Hospital

    Reggio Emilia, 42100

  • University Hospital of Siena

    Siena, 53100

Other trials in Italy

Poland11 sites

  • Uniwersytet Medyczny Bialistok

    Bialystok, 15540

  • Hospicjum im. ks. T. Dutkiewicza SAC

    Gdansk, 80208

  • Przychodnia KOMED

    Konin, 62500

  • Nzoz Vesalius

    Krakow, 31108

  • MS Clinsearch

    Lublin, 20064

  • Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc

    Olsztyn, 10357

  • Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku

    Otwock, 05400

  • Med-Polonia

    Poznan, 60693

  • Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego

    Szczecin, 70891

  • Centrum Onkologii - Instytut im. M. Skłodowskiej - Curie

    Warsaw, 02781

  • Fundacja Hospicjum Onkologiczne św. Krzysztofa

    Warsaw, 02781

Other trials in Poland

Germany10 sites

  • Hospital Grosshansdorf

    Großhansdorf, 22927

  • Lungenklinik Hemer

    Hemer, 58675

  • Klinikum Kassel GmbH

    Kassel, 34125

  • University Medical center Kiel

    Kiel, 24116

  • Klinik Löwenstein

    Löwenstein, 74245

  • Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie

    Mannheim, 68167

  • Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden

    Minden, 32429

  • LMU Klinikum der Universität München

    Munich, 80336

  • Pius Hospital Oldenburg

    Oldenburg, 26121

  • Mathias Spital Rheine Medizinische Klinik V

    Rheine, 48431

Other trials in Germany

Spain10 sites

  • USP Institut Universitari Dexeus

    Barcelona, 08028

  • University Hospital P. Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08041

  • Ico-Hospital Germans Trias I Pujol

    Barcelona, 08916

  • Hospital Provencial de Castellón

    Castellon, 12002

  • Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ

    Madrid, 28040

  • Hospital Univesitario Puerta de Hierro

    Madrid, 28222

  • H.R.U. Carlos Haya Málaga

    Málaga, 29010

  • Hospital Son Llatzer

    Palma de Mallorca

  • Hospital Clinico de Valencia

    Valencia, 46010

Other trials in Spain

Romania9 sites

  • SC Oncopremium Team SRL

    Baia Mare

  • Spit. Jud. de Urgenţă

    Brăila

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 50098

  • Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Oncolab SRL

    Craiova, 200385

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"

    Suceava

  • Oncomed SRL, Department of Medical Oncology

    Timișoara

Other trials in Romania

France5 sites

  • University Hospital of Angers

    Angers, 49933

  • Ambroise Paré Hospital

    Boulogne-Billancourt, 92104

  • Hopital Nord

    Marseille, 13915

  • Pitié-Salpetrière Hospital

    Paris, 75651

  • Pontchaillou Hospital

    Rennes, 35033

Other trials in France

Czechia2 sites

  • Fakultni nemocnice Plzen

    Plzen-Bory, 30599

  • Vseobecna fakultni nemocnice

    Prague, 18008

Other trials in Czechia

About this study

Official title: 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.

Being tested
Vx-001, Placebo
Keywords
NSCLC, Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vx-001Drug

  • PlaceboDrug

Study groups in NCT01935154
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Receives: Drug: Placebo
Vx-001ExperimentalVx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Receives: Drug: Vx-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.

    Measured: 12 months

Secondary outcomes (2)

  1. Overall survival rate

    Measured: 12 months

  2. Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.

    Measured: Traitement failure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01935154
Sponsor's protocol ID
Vx-001-201
Status last verified
Jun 2019
First submitted
26 Aug 2013
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • Gridelli C, Ciuleanu T, Domine M, Szczesna A, Bover I, Cobo M, Kentepozidis N, Zarogoulidis K, Kalofonos C, Kazarnowisz A, Korozan M, de Las Penas R, Majem M, Chella A, Griesinger F, Bournakis E, Sadjadian P, Kotsakis A, Chinet T, Syrigos KN, Correale P, Gallou C, Jamet JM, Vetsika EK, Kosmatopoulos K, Georgoulias V; Vx-001-201 trial team. Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial. Br J Cancer. 2020 May;122(10):1461-1466. doi: 10.1038/s41416-020-0785-y. Epub 2020 Mar 25.

    PubMed 32210365

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vx-001 in people with Non-small Cell Lung Cancer Metastatic, run by Vaxon Biotech at 70 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in Greece, Italy, Poland, Germany, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01935154, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

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