Efficacy Study of Vx001 Vaccine in NSCLC Patients
- 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
- Male or female ≥18 years of age;
- 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;
- 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);
- Documented HLA-A*0201 positivity, as determined by a local laboratory;
- 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;
- CR, PR, or SD according to RECIST 1.1 criteria after the completion of platinum-based first-line chemotherapy;
- ECOG performance status 0, 1;
Main
- 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 (e.g., interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization;
- Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization;
- Prior treatment with any investigational drugs, within 4 weeks prior to randomization;
- 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)
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