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Efficacy Study of Vx001 Vaccine in NSCLC Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vaxon Biotech
ClinicalTrials.gov Identifier:
NCT01935154
First received: August 26, 2013
Last updated: November 4, 2016
Last verified: December 2015
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer Metastatic Drug: Vx-001 Drug: Placebo Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vaxon Biotech:

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

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 221
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935154

  Show 70 Study Locations
Sponsors and Collaborators
Vaxon Biotech
Investigators
Principal Investigator: Vassilis Georgoulias, MD,PhD Iaso General Hospital
  More Information

Responsible Party: Vaxon Biotech
ClinicalTrials.gov Identifier: NCT01935154     History of Changes
Other Study ID Numbers: Vx-001-201
Study First Received: August 26, 2013
Last Updated: November 4, 2016

Keywords provided by Vaxon Biotech:
NSCLC
Vaccine

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

ClinicalTrials.gov processed this record on June 23, 2017