Efficacy Study of Vx001 Vaccine in NSCLC Patients

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer Metastatic
• Interventions: Drug: Placebo; Drug: Vx-001

• Registration Number: NCT01935154
• Lead Sponsor: Vaxon Biotech

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.	12 months

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	12 months
Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.	Traitement failure

Trial Locations

Locations (70)

251 General Airforce Hospital; 🇬🇷 Athens, Greece

Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc; 🇵🇱 Olsztyn, Poland

Med-Polonia; 🇵🇱 Poznan, Poland

General hospital of thoracic diseases Sotiria; 🇬🇷 Athens, Greece

General Oncology Hospital of Kifissia Agioi Anargyroi; 🇬🇷 Nea Kifissia, Greece

Przychodnia KOMED; 🇵🇱 Konin, Poland

General Hospital Alexandra; 🇬🇷 Athens, Greece

University General Hospital Papageorgiou; 🇬🇷 Thessaloniki, Greece

Uniwersytet Medyczny Bialistok; 🇵🇱 Bialystok, Poland

Spit. Jud. de Urgenţă; 🇷🇴 Brăila, Romania

Oncomed SRL, Department of Medical Oncology; 🇷🇴 Timisoara, Romania

Iaso General Hospital Cholargos; 🇬🇷 Athens, Greece

General Hospital G. Papanikolaou; 🇬🇷 Thessaloniki, Greece

University General Hospital of Ioannina; 🇬🇷 Ioannina, Greece

Nzoz Vesalius; 🇵🇱 Krakow, Poland

MS Clinsearch; 🇵🇱 Lublin, Poland

Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego; 🇵🇱 Szczecin, Poland

Fundacja Hospicjum Onkologiczne św. Krzysztofa; 🇵🇱 Warszawa, Poland

Spitalul Universitar de Urgenta Bucuresti; 🇷🇴 Bucuresti, Romania

Medisprof SRL; 🇷🇴 Cluj-Napoca, Romania

Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca; 🇷🇴 Cluj-Napoca, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"; 🇷🇴 Suceava, Romania

Fakultni nemocnice Plzen; 🇨🇿 Plzen-Bory, Czechia

Hopital Nord; 🇫🇷 Marseille, France

University Hospital of Angers; 🇫🇷 Angers, France

Vseobecna fakultni nemocnice; 🇨🇿 Praha 2, Czechia

Ambroise Paré Hospital; 🇫🇷 Boulogne Billancourt, France

Pitié-Salpetrière Hospital; 🇫🇷 Paris, France

Hospital Grosshansdorf; 🇩🇪 Grosshansdorf, Germany

Pontchaillou Hospital; 🇫🇷 Rennes, France

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

Klinikum Kassel GmbH; 🇩🇪 Kassel, Germany

University Medical center Kiel; 🇩🇪 Kiel, Germany

Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Klinik Löwenstein; 🇩🇪 Löwenstein, Germany

Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie; 🇩🇪 Mannheim, Germany

LMU Klinikum der Universität München; 🇩🇪 Munich, Germany

University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Greece

Pius Hospital Oldenburg; 🇩🇪 Oldenburg, Germany

Mathias Spital Rheine Medizinische Klinik V; 🇩🇪 Rheine, Germany

Aretaieio Hospital; 🇬🇷 Athens, Greece

University Hospital of Heraklion; 🇬🇷 Heraklion, Greece

University Hospital of Patras; 🇬🇷 Rio, Greece

SG Moscati Hospital; 🇮🇹 Avellino, Italy

San Paolo Hospital; 🇮🇹 Milano, Italy

European Institute of Oncology; 🇮🇹 Milan, Italy

Insituto Oncologico Veneto; 🇮🇹 Padova, Italy

University Hospital of Siena; 🇮🇹 Siena, Italy

Hospicjum im. ks. T. Dutkiewicza SAC; 🇵🇱 Gdansk, Poland

Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku; 🇵🇱 Otwock, Poland

Centrum Onkologii - Instytut im. M. Skłodowskiej - Curie; 🇵🇱 Warszawa, Poland

SC Oncopremium Team SRL; 🇷🇴 Baia Mare, Romania

Oncolab SRL; 🇷🇴 Craiova, Romania

Spitalul Clinic Judetean de Urgenta Sibiu; 🇷🇴 Sibiu, Romania

University Hospital P. Vall d'Hebron; 🇪🇸 Barcelona, Spain

USP Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain

Ico-Hospital Germans Trias I Pujol; 🇪🇸 Barcelona, Spain

Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ; 🇪🇸 Madrid, Spain

Hospital de la Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Univesitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Spain

H.R.U. Carlos Haya Málaga; 🇪🇸 Málaga, Spain

G. Rummo Hospital; 🇮🇹 Benevento, Italy

Mater Domini Catanzaro Hospital; 🇮🇹 Catanzaro, Italy

Seconda Universita degli Studi Napoli Hospital; 🇮🇹 Naples, Italy

S. Maria della Misericordia Hospital; 🇮🇹 Perugia, Italy

A.O.U di Pisa Hospital; 🇮🇹 Pisa, Italy

S. Maria Nuova Hospital; 🇮🇹 Reggio Emilia, Italy

Hospital Clinico de Valencia; 🇪🇸 Valencia, Spain

Hospital Provencial de Castellón; 🇪🇸 Castellón, Spain