This trial is active, not recruiting.

Condition non-small cell lung cancer metastatic
Treatments vx-001, placebo
Phase phase 2
Sponsor Vaxon Biotech
Start date August 2012
End date December 2016
Trial size 250 participants
Trial identifier NCT01935154, Vx-001-201


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
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.

Primary Outcomes

Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients.
time frame: 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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;

Additional Information

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
Principal investigator Vassilis Georgoulias, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Vaxon Biotech.