MedPath

Efficacy Study of Vx001 Vaccine in NSCLC Patients

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer Metastatic
Interventions
Drug: Placebo
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

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
GroupInterventionDescription
PlaceboPlaceboPlacebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Vx-001Vx-001Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Primary Outcome Measures
NameTimeMethod
Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.12 months
Secondary Outcome Measures
NameTimeMethod
Overall survival rate12 months
Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.Traitement failure

Trial Locations

Locations (70)

Fakultni nemocnice Plzen

🇨🇿

Plzen-Bory, Czechia

Vseobecna fakultni nemocnice

🇨🇿

Praha 2, Czechia

University Hospital of Angers

🇫🇷

Angers, France

Ambroise Paré Hospital

🇫🇷

Boulogne Billancourt, France

Hopital Nord

🇫🇷

Marseille, France

Pitié-Salpetrière Hospital

🇫🇷

Paris, France

Pontchaillou Hospital

🇫🇷

Rennes, France

Hospital Grosshansdorf

🇩🇪

Grosshansdorf, Germany

Lungenklinik Hemer

🇩🇪

Hemer, Germany

Klinikum Kassel GmbH

🇩🇪

Kassel, Germany

Scroll for more (60 remaining)
Fakultni nemocnice Plzen
🇨🇿Plzen-Bory, Czechia

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.