Efficacy Study of Vx001 Vaccine in NSCLC Patients
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.
|Non-small Cell Lung Cancer Metastatic||Drug: Vx-001 Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients. [ Time Frame: 12 months ]
- Overall survival rate [ Time Frame: 12 months ]
- Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients. [ Time Frame: Traitement failure ]
- 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. [ Time Frame: week 18 ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935154
Show 70 Study Locations
|Principal Investigator:||Vassilis Georgoulias, MD,PhD||Iaso General Hospital|