Efficacy Study of Vx001 Vaccine in NSCLC Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01935154|
Recruitment Status : Unknown
Verified December 2015 by Vaxon Biotech.
Recruitment status was: Active, not recruiting
First Posted : September 4, 2013
Last Update Posted : November 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Metastatic||Drug: Vx-001 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935154
Show 70 Study Locations
|Principal Investigator:||Vassilis Georgoulias, MD,PhD||Iaso General Hospital|