Efficacy Study of Vx001 Vaccine in NSCLC Patients

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Vx001 Vaccine in HLA-A*0201 Positive Patients With TERT Positive Stage IV or Recurrent Stage I-III NSCLC

Conditions
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Non-small Cell Lung Cancer Metastatic

Intervention / Treatment
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* Drug: Vx-001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female ≥18 years of age; 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; 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); Documented HLA-A*0201 positivity, as determined by a local laboratory; 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; CR, PR, or SD according to RECIST 1.1 criteria after the completion of platinum-based first-line chemotherapy; ECOG performance status 0, 1; Main Exclusion Criteria: Mixed small cell and NSCLC histologies; Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy; Prior treatment with cancer vaccines; Prior treatment with immunotherapy (e.g., interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization; Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization; Prior treatment with any investigational drugs, within 4 weeks prior to randomization; Patients with brain metastases;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression. | Drug: Placebo<br> <br> |
| Experimental: Vx-001<br>Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression. | Drug: Vx-001<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 12 months | 
| Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients. |  | Traitement failure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Vaccine