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Efficacy Study of Vx001 Vaccine in NSCLC Patients

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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
Information provided by (Responsible Party):
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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Drug: Placebo
Experimental: Vx-001
Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Drug: Vx-001

Primary Outcome Measures :
  1. Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall survival rate [ Time Frame: 12 months ]
  2. Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients. [ Time Frame: Traitement failure ]

Other Outcome Measures:
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

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

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Sponsors and Collaborators
Vaxon Biotech
Principal Investigator: Vassilis Georgoulias, MD,PhD Iaso General Hospital

Responsible Party: Vaxon Biotech
ClinicalTrials.gov Identifier: NCT01935154     History of Changes
Other Study ID Numbers: Vx-001-201
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: December 2015

Keywords provided by Vaxon Biotech:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs