Non-small Cell Lung Cancer Metastatic
Conditions
Keywords
NSCLC, Vaccine
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.
Interventions
DRUGVx-001
DRUGPlacebo
Sponsors
Vaxon Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate | 12 months |
| Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients. | Traitement failure |
Other
| Measure | Time frame |
|---|---|
| Comparison of vaccine induced immune responses between Vx-001 vs placebo in terms of frequency of TERT specific IFN-γ and perforin producing T cells in the blood of patients. | week 18 |
Countries
Czechia, France, Germany, Greece, Italy, Poland, Romania, Spain
Outcome results
None listed