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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression. |
|
| Vx-001 | Experimental | Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vx-001 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | 12 months | |
| Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients. | Traitement failure |
| Measure | Description | 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. | week 18 |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vassilis Georgoulias, MD,PhD | Iaso General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultni nemocnice Plzen | Plzen-Bory | 30599 | Czechia | |||
| Vseobecna fakultni nemocnice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32210365 | Derived | 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. |
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|
| Prague |
| 18008 |
| Czechia |
| University Hospital of Angers | Angers | 49933 | France |
| Ambroise Paré Hospital | Boulogne-Billancourt | 92104 | France |
| Hopital Nord | Marseille | 13915 | France |
| Pitié-Salpetrière Hospital | Paris | 75651 | France |
| Pontchaillou Hospital | Rennes | 35033 | France |
| Hospital Grosshansdorf | Großhansdorf | 22927 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Klinikum Kassel GmbH | Kassel | 34125 | Germany |
| University Medical center Kiel | Kiel | 24116 | Germany |
| Klinik Löwenstein | Löwenstein | 74245 | Germany |
| Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie | Mannheim | 68167 | Germany |
| Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| LMU Klinikum der Universität München | Munich | 80336 | Germany |
| Pius Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Mathias Spital Rheine Medizinische Klinik V | Rheine | 48431 | Germany |
| University Hospital of Alexandroupolis | Alexandroupoli | 68100 | Greece |
| 251 General Airforce Hospital | Athens | 11525 | Greece |
| General hospital of thoracic diseases Sotiria | Athens | 11527 | Greece |
| Aretaieio Hospital | Athens | 11528 | Greece |
| General Hospital Alexandra | Athens | 11528 | Greece |
| Iaso General Hospital Cholargos | Athens | 15562 | Greece |
| University Hospital of Heraklion | Heraklion | 71110 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| General Oncology Hospital of Kifissia Agioi Anargyroi | Nea Kifissia | 14564 | Greece |
| University Hospital of Patras | Rio | 26504 | Greece |
| University General Hospital Papageorgiou | Thessaloniki | 56429 | Greece |
| General Hospital G. Papanikolaou | Thessaloniki | 57010 | Greece |
| SG Moscati Hospital | Avellino | 83100 | Italy |
| G. Rummo Hospital | Benevento | 82100 | Italy |
| Mater Domini Catanzaro Hospital | Catanzaro | 88100 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| San Paolo Hospital | Milan | 20142 | Italy |
| Seconda Universita degli Studi Napoli Hospital | Naples | 80131 | Italy |
| Insituto Oncologico Veneto | Padova | 35128 | Italy |
| S. Maria della Misericordia Hospital | Perugia | 06132 | Italy |
| A.O.U di Pisa Hospital | Pisa | 56126 | Italy |
| S. Maria Nuova Hospital | Reggio Emilia | 42100 | Italy |
| University Hospital of Siena | Siena | 53100 | Italy |
| Uniwersytet Medyczny Bialistok | Bialystok | 15540 | Poland |
| Hospicjum im. ks. T. Dutkiewicza SAC | Gdansk | 80208 | Poland |
| Przychodnia KOMED | Konin | 62500 | Poland |
| Nzoz Vesalius | Krakow | 31108 | Poland |
| MS Clinsearch | Lublin | 20064 | Poland |
| Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc | Olsztyn | 10357 | Poland |
| Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku | Otwock | 05400 | Poland |
| Med-Polonia | Poznan | 60693 | Poland |
| Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego | Szczecin | 70891 | Poland |
| Centrum Onkologii - Instytut im. M. Skłodowskiej - Curie | Warsaw | 02781 | Poland |
| Fundacja Hospicjum Onkologiczne św. Krzysztofa | Warsaw | 02781 | Poland |
| SC Oncopremium Team SRL | Baia Mare | Romania |
| Spit. Jud. de Urgenţă | Brăila | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 50098 | Romania |
| Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Medisprof SRL | Cluj-Napoca | 400058 | Romania |
| Oncolab SRL | Craiova | 200385 | Romania |
| Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu | 550245 | Romania |
| Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou" | Suceava | Romania |
| Oncomed SRL, Department of Medical Oncology | Timișoara | Romania |
| USP Institut Universitari Dexeus | Barcelona | 08028 | Spain |
| University Hospital P. Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Ico-Hospital Germans Trias I Pujol | Barcelona | 08916 | Spain |
| Hospital Provencial de Castellón | Castellon | 12002 | Spain |
| Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ | Madrid | 28040 | Spain |
| Hospital Univesitario Puerta de Hierro | Madrid | 28222 | Spain |
| H.R.U. Carlos Haya Málaga | Málaga | 29010 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Spain |
| Hospital Clinico de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| C521181 | telomerase reverse transcriptase p572Y, human |
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