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Trial record 1 of 1 for:    Vx-001
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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. Identifier: NCT01935154
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : June 19, 2019
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

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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
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 identifier (NCT number): NCT01935154

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Sponsors and Collaborators
Vaxon Biotech
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Principal Investigator: Vassilis Georgoulias, MD,PhD Iaso General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vaxon Biotech Identifier: NCT01935154    
Other Study ID Numbers: Vx-001-201
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by Vaxon Biotech:
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases