A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)

• Register: EUCTR
• Last refreshed on: 17 December 2012
• Main ID: EUCTR2011-005968-24-IT
• Date of registration: 07/08/2012
• Prospective Registration: No
• Primary sponsor: VAXON BIOTECH
• Public title: A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)
• Scientific title: A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III) - VaxLung
• Date of first enrolment: 26/06/2012
• Target sample size: 150
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005968-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Greece, Italy

Contacts

• Name: Marina Iche
• Affiliation: Vaxon Biotech

• Name: Marina Iche
• Affiliation: Vaxon Biotech

Key inclusion & exclusion criteria

Inclusion criteria:
- MF from 18 years of age; - Documented stage IV NSCLC or recurrent stage I-III disease; - Patients treated with 4 cycles platinum based 1st line chemotherapy; - Documented HLA-A*0201 positive; - TERT-positive NSCLC.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- 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 within four weeks prior to randomization.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stabile disease) within 3 months after platinum based 1st line chemotherapy, only HLA-A*0201 positive patients with TERT expressing tumors will be included.
MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: peptide-based cancer vaccine
Product Code: Vx-001
Pharmaceutical Form: Solution for injection
Current Sponsor code: ARG-Vx001
Other descriptive name: peptide-based cancer vaccine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Current Sponsor code: TYR-Vx001
Other descriptive name: peptide-based cancer vaccine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: MONTANIDE ISA 51 VG
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 595-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To compare survival rate at 12 months in Vx-001treated vs placebo treated patients.

Primary end point(s): The survival rate at 12 months.

Timepoint(s) of evaluation of this end point: 12 months

Secondary Objective: Time-to-event comparision of overall survival (OS) in Vx-001treated vs placebo treated patients. Comparision of Time to treatment failure in Vx-001 treated vs placebo treated patients.

Secondary Outcome(s)

Secondary end point(s): - Time to event OS; - Time to treatment failure.

Timepoint(s) of evaluation of this end point: Change according to disease progression.

Secondary ID(s)

2011-005968-24-GR

Vx-001-201

Source(s) of Monetary Support

VAXON BIOTECH