Clinical trial NCT01935154: Efficacy Study of Vx001 Vaccine in NSCLC Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic
Keywords: NSCLC
Vaccine
Lead sponsor: Vaxon Biotech
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival rate
timeFrame: 12 months
measure: Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.
timeFrame: Traitement failure
Other outcomes:
measure: 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.
timeFrame: week 18
Locations:
city: Plzen-Bory
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice
city: Angers
country: France
facility: University Hospital of Angers
city: Boulogne Billancourt
country: France
facility: Ambroise Paré Hospital
city: Marseille
country: France
facility: Hopital Nord
city: Paris
country: France
facility: Pitié-Salpetrière Hospital
city: Rennes
country: France
facility: Pontchaillou Hospital
city: Grosshansdorf
country: Germany
facility: Hospital Grosshansdorf
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
city: Kiel
country: Germany
facility: University Medical center Kiel
city: Löwenstein
country: Germany
facility: Klinik Löwenstein
city: Mannheim
country: Germany
facility: Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie
city: Minden
country: Germany
facility: Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden
city: Munich
country: Germany
facility: LMU Klinikum der Universität München
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
city: Rheine
country: Germany
facility: Mathias Spital Rheine Medizinische Klinik V
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: 251 General Airforce Hospital
city: Athens
country: Greece
facility: General hospital of thoracic diseases Sotiria
city: Athens
country: Greece
facility: Aretaieio Hospital
city: Athens
country: Greece
facility: General Hospital Alexandra
city: Athens
country: Greece
facility: Iaso General Hospital Cholargos
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Nea Kifissia
country: Greece
facility: General Oncology Hospital of Kifissia Agioi Anargyroi
city: Rio
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: University General Hospital Papageorgiou
city: Thessaloniki
country: Greece
facility: General Hospital G. Papanikolaou
city: Avellino
country: Italy
facility: SG Moscati Hospital
city: Benevento
country: Italy
facility: G. Rummo Hospital
city: Catanzaro
country: Italy
facility: Mater Domini Catanzaro Hospital
city: Milano
country: Italy
facility: San Paolo Hospital
city: Milan
country: Italy
facility: European Institute of Oncology
city: Naples
country: Italy
facility: Seconda Universita degli Studi Napoli Hospital
city: Padova
country: Italy
facility: Insituto Oncologico Veneto
city: Perugia
country: Italy
facility: S. Maria della Misericordia Hospital
city: Pisa
country: Italy
facility: A.O.U di Pisa Hospital
city: Reggio Emilia
country: Italy
facility: S. Maria Nuova Hospital
city: Siena
country: Italy
facility: University Hospital of Siena
city: Bialystok
country: Poland
facility: Uniwersytet Medyczny Bialistok
city: Gdansk
country: Poland
facility: Hospicjum im. ks. T. Dutkiewicza SAC
city: Konin
country: Poland
facility: Przychodnia KOMED
city: Krakow
country: Poland
facility: Nzoz Vesalius
city: Lublin
country: Poland
facility: MS Clinsearch
city: Olsztyn
country: Poland
facility: Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku
city: Poznan
country: Poland
facility: Med-Polonia
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M. Skłodowskiej - Curie
city: Warszawa
country: Poland
facility: Fundacja Hospicjum Onkologiczne św. Krzysztofa
city: Baia Mare
country: Romania
facility: SC Oncopremium Team SRL
city: Brăila
country: Romania
facility: Spit. Jud. de Urgenţă
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Cluj-Napoca
country: Romania
facility: Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Craiova
country: Romania
facility: Oncolab SRL
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Suceava
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"
city: Timisoara
country: Romania
facility: Oncomed SRL, Department of Medical Oncology
city: Barcelona
country: Spain
facility: USP Institut Universitari Dexeus
city: Barcelona
country: Spain
facility: University Hospital P. Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Ico-Hospital Germans Trias I Pujol
city: Castellón
country: Spain
facility: Hospital Provencial de Castellón
city: Madrid
country: Spain
facility: Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ
city: Madrid
country: Spain
facility: Hospital Univesitario Puerta de Hierro
city: Málaga
country: Spain
facility: H.R.U. Carlos Haya Málaga
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
Study officials:
affiliation: Iaso General Hospital
name: Vassilis Georgoulias, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.