Efficacy Study of Vx001 Vaccine in NSCLC Patients

Non-small Cell Lung Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935154
• Other study ID #: Vx-001-201
• Status: Completed
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: January 2017

Study information

• Verified date: June 2019
• Source: Vaxon Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Metastatic

Intervention

Drug:
• Vx-001

• Placebo

Locations

Country	Name	City	State
Czechia	Fakultni nemocnice Plzen	Plzen-Bory
Czechia	Vseobecna fakultni nemocnice	Praha 2
France	University Hospital of Angers	Angers
France	Ambroise Paré Hospital	Boulogne Billancourt
France	Hopital Nord	Marseille
France	Pitié-Salpetrière Hospital	Paris
France	Pontchaillou Hospital	Rennes
Germany	Hospital Grosshansdorf	Grosshansdorf
Germany	Lungenklinik Hemer	Hemer
Germany	Klinikum Kassel GmbH	Kassel
Germany	University Medical center Kiel	Kiel
Germany	Klinik Löwenstein	Löwenstein
Germany	Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie	Mannheim
Germany	Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden	Minden
Germany	LMU Klinikum der Universität München	Munich
Germany	Pius Hospital Oldenburg	Oldenburg
Germany	Mathias Spital Rheine Medizinische Klinik V	Rheine
Greece	University Hospital of Alexandroupolis	Alexandroupolis
Greece	251 General Airforce Hospital	Athens
Greece	Aretaieio Hospital	Athens
Greece	General Hospital Alexandra	Athens
Greece	General hospital of thoracic diseases Sotiria	Athens
Greece	Iaso General Hospital Cholargos	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	University General Hospital of Ioannina	Ioannina
Greece	General Oncology Hospital of Kifissia Agioi Anargyroi	Nea Kifissia
Greece	University Hospital of Patras	Rio
Greece	General Hospital G. Papanikolaou	Thessaloniki
Greece	University General Hospital Papageorgiou	Thessaloniki
Italy	SG Moscati Hospital	Avellino
Italy	G. Rummo Hospital	Benevento
Italy	Mater Domini Catanzaro Hospital	Catanzaro
Italy	European Institute of Oncology	Milan
Italy	San Paolo Hospital	Milano
Italy	Seconda Universita degli Studi Napoli Hospital	Naples
Italy	Insituto Oncologico Veneto	Padova
Italy	S. Maria della Misericordia Hospital	Perugia
Italy	A.O.U di Pisa Hospital	Pisa
Italy	S. Maria Nuova Hospital	Reggio Emilia
Italy	University Hospital of Siena	Siena
Poland	Uniwersytet Medyczny Bialistok	Bialystok
Poland	Hospicjum im. ks. T. Dutkiewicza SAC	Gdansk
Poland	Przychodnia KOMED	Konin
Poland	Nzoz Vesalius	Krakow
Poland	MS Clinsearch	Lublin
Poland	Oddzial Onkologii z Pododdzialem Chemioterapii Nowotworów Pluc	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorób Pluc i Gruzlicy w Otwocku	Otwock
Poland	Med-Polonia	Poznan
Poland	Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego	Szczecin
Poland	Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie	Warszawa
Poland	Fundacja Hospicjum Onkologiczne sw. Krzysztofa	Warszawa
Romania	SC Oncopremium Team SRL	Baia Mare
Romania	Spit. Jud. de Urgenta	Braila
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Institutului Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca	Cluj-Napoca
Romania	Medisprof SRL	Cluj-Napoca
Romania	Oncolab SRL	Craiova
Romania	Spitalul Clinic Judetean de Urgenta Sibiu	Sibiu
Romania	Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"	Suceava
Romania	Oncomed SRL, Department of Medical Oncology	Timisoara
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Ico-Hospital Germans Trias I Pujol	Barcelona
Spain	University Hospital P. Vall d'Hebron	Barcelona
Spain	USP Institut Universitari Dexeus	Barcelona
Spain	Hospital Provencial de Castellón	Castellón
Spain	Hospital Univesitario Puerta de Hierro	Madrid
Spain	Oncologia Medica FUNDACIÓN JIMÉNEZ DÍAZ	Madrid
Spain	H.R.U. Carlos Haya Málaga	Málaga
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Hospital Clinico de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Vaxon Biotech

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Greece,  Italy,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of vaccine induced immune responses between Vx-001 vs placebo in terms of frequency of TERT specific IFN-? and perforin producing T cells in the blood of patients.		week 18
Primary	Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.		12 months
Secondary	Overall survival rate		12 months
Secondary	Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.		Traitement failure