Efficacy Study of Vx001 Vaccine in NSCLC Patients

NCT01935154 | Completed Phase 2

• 1 other identifier: Vx-001-201
• Study Type: interventional
• Target: 221
• Locations: 8 countries
• Sites: 70

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

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

NSCLC; Vaccine

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (2)

• Overall survival rate

  12 months

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

  Traitement failure

Other Outcomes (1)

• 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.

  week 18

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.

Drug: Placebo

Vx-001

EXPERIMENTAL

Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.

Drug: Vx-001

Interventions

Vx-001 DRUG

Vx-001

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age;
• 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;
• 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);
• Documented HLA-A\*0201 positivity, as determined by a local laboratory;
• 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;
• CR, PR, or SD according to RECIST 1.1 criteria after the completion of platinum-based first-line chemotherapy;
• ECOG performance status 0, 1;

You may not qualify if:

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

Sponsors & Collaborators

• Vaxon Biotech: lead

Study Sites (70)

Fakultni nemocnice Plzen

Plzen-Bory, 30599, Czechia

Location

Vseobecna fakultni nemocnice

Prague, 18008, Czechia

Location

University Hospital of Angers

Angers, 49933, France

Location

Ambroise Paré Hospital

Boulogne-Billancourt, 92104, France

Location

Hopital Nord

Marseille, 13915, France

Location

Pitié-Salpetrière Hospital

Paris, 75651, France

Location

Pontchaillou Hospital

Rennes, 35033, France

Location

Hospital Grosshansdorf

Großhansdorf, 22927, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Klinikum Kassel GmbH

Kassel, 34125, Germany

Location

University Medical center Kiel

Kiel, 24116, Germany

Location

Klinik Löwenstein

Löwenstein, 74245, Germany

Location

Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie

Mannheim, 68167, Germany

Location

Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

LMU Klinikum der Universität München

Munich, 80336, Germany

Location

Pius Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Mathias Spital Rheine Medizinische Klinik V

Rheine, 48431, Germany

Location

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

251 General Airforce Hospital

Athens, 11525, Greece

Location

General hospital of thoracic diseases Sotiria

Athens, 11527, Greece

Location

Aretaieio Hospital

Athens, 11528, Greece

Location

General Hospital Alexandra

Athens, 11528, Greece

Location

Iaso General Hospital Cholargos

Athens, 15562, Greece

Location

University Hospital of Heraklion

Heraklion, 71110, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

General Oncology Hospital of Kifissia Agioi Anargyroi

Nea Kifissia, 14564, Greece

Location

University Hospital of Patras

Rio, 26504, Greece

Location

University General Hospital Papageorgiou

Thessaloniki, 56429, Greece

Location

General Hospital G. Papanikolaou

Thessaloniki, 57010, Greece

Location

SG Moscati Hospital

Avellino, 83100, Italy

Location

G. Rummo Hospital

Benevento, 82100, Italy

Location

Mater Domini Catanzaro Hospital

Catanzaro, 88100, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

San Paolo Hospital

Milan, 20142, Italy

Location

Seconda Universita degli Studi Napoli Hospital

Naples, 80131, Italy

Location

Insituto Oncologico Veneto

Padua, 35128, Italy

Location

S. Maria della Misericordia Hospital

Perugia, 06132, Italy

Location

A.O.U di Pisa Hospital

Pisa, 56126, Italy

Location

S. Maria Nuova Hospital

Reggio Emilia, 42100, Italy

Location

University Hospital of Siena

Siena, 53100, Italy

Location

Uniwersytet Medyczny Bialistok

Bialystok, 15540, Poland

Location

Hospicjum im. ks. T. Dutkiewicza SAC

Gdansk, 80208, Poland

Location

Przychodnia KOMED

Konin, 62500, Poland

Location

Nzoz Vesalius

Krakow, 31108, Poland

Location

MS Clinsearch

Lublin, 20064, Poland

Location

Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc

Olsztyn, 10357, Poland

Location

Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku

Otwock, 05400, Poland

Location

Med-Polonia

Poznan, 60693, Poland

Location

Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego

Szczecin, 70891, Poland

Location

Centrum Onkologii - Instytut im. M. Skłodowskiej - Curie

Warsaw, 02781, Poland

Location

Fundacja Hospicjum Onkologiczne św. Krzysztofa

Warsaw, 02781, Poland

Location

SC Oncopremium Team SRL

Baia Mare, Romania

Location

Spit. Jud. de Urgenţă

Brăila, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 50098, Romania

Location

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

Cluj-Napoca, 400015, Romania

Location

Medisprof SRL

Cluj-Napoca, 400058, Romania

Location

Oncolab SRL

Craiova, 200385, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, 550245, Romania

Location

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

Suceava, Romania

Location

Oncomed SRL, Department of Medical Oncology

Timișoara, Romania

Location

USP Institut Universitari Dexeus

Barcelona, 08028, Spain

Location

University Hospital P. Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Ico-Hospital Germans Trias I Pujol

Barcelona, 08916, Spain

Location

Hospital Provencial de Castellón

Castellon, 12002, Spain

Location

Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ

Madrid, 28040, Spain

Location

Hospital Univesitario Puerta de Hierro

Madrid, 28222, Spain

Location

H.R.U. Carlos Haya Málaga

Málaga, 29010, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Spain

Location

Hospital Clinico de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 32210365 DERIVED

MeSH Terms

Interventions

telomerase reverse transcriptase p572Y, human

Study Officials

• Vassilis Georgoulias, MD,PhD

  Iaso General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 4, 2013
• Study Start: August 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

IT (11); DE (10); RO (9); FR (5); GR (12); ES (10); CZ (2); PL (11)