Efficacy Study of Vx001 Vaccine in NSCLC Patients

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer Metastatic
• Interventions: Drug: Placebo; Drug: Vx-001

• Registration Number: NCT01935154
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.
Vx-001	Vx-001	Vx-001 will be administered evey 3 weeks from w0 to W15 than every 12 weeks until disease progression.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	12 months
Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients.	Traitement failure

Trial Locations

Locations (70)

Fakultni nemocnice Plzen; 🇨🇿 Plzen-Bory, Czechia

Vseobecna fakultni nemocnice; 🇨🇿 Praha 2, Czechia

University Hospital of Angers; 🇫🇷 Angers, France

Ambroise Paré Hospital; 🇫🇷 Boulogne Billancourt, France

Hopital Nord; 🇫🇷 Marseille, France

Pitié-Salpetrière Hospital; 🇫🇷 Paris, France

Pontchaillou Hospital; 🇫🇷 Rennes, France

Hospital Grosshansdorf; 🇩🇪 Grosshansdorf, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

Klinikum Kassel GmbH; 🇩🇪 Kassel, Germany

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