Non-small cell lung cancer MedDRA version: 17.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CRYPTIC PEPTIDE
Product Code: ARG-Vx001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: Vx-001
Other descriptive name: OLIGOPEPTIDE
Concentrati
Sponsors
Vaxon Biotech
Eligibility
Sex/Gender
All
Inclusion criteria
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 criteria after the completion of platinum-based first-line chemotherapy; 7. First vaccination have to be administered no more than 4 weeks after the last administration of platinum-based 1st line chemotherapy; 8. ECOG performance status 0, 1; 9. Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria; 10. Patients must have adequate haematological function: • Platelet count >/= 100 x 109/L; • WBC count >/= 2.5 x 109/L; • Hemoglobin >/= 90g /L; 11. Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential must have a negative urine pregnancy test at baseline and agree to practice adequate contraception for 30 days prior to administration of investigational product, throughout the study treatment period and 30 days after completion of injections; 12. In the investigator’s opinion, the patient is capable and willing to comply with the requirements of the study; 13. Willing and able to sign a written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
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 (eg 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; 8. Past and current history of neoplasm other than NSCLC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated with no evidence of disease for at least five years; 9. Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study; 10. Any pre-existing medical condition requiring concomitant systemic corticosteroid or immunosuppressive therapy. The use of inhaled corticosteroids for COPD or topical steroids is allowed; 11. Known hepatitis B and/or C infection, testing not required; 12. Known HIV-positivity, testing not required; 13. Clinically significant hepatic dysfunction (ALT>2.5 times normal upper limits [ULN], AST>2.5 times ULN, bilirubin>1.5 times ULN); 14. Clinically significant renal dysfunction (serum creatinine>1.5 time ULN); 15. Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months of randomization) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable); 16. Splenectomy or splenic irradiation; 17. Any infectious condition that, in the opinion of the investigator, could compromise the patient’s ability to develop an immune response; 18. Pregnant or lactating females (female patients of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits); 19. Alcohol or drug use or dependence; 20. Requirement of concurrent treatment with prohibited medication (investigational product, other anti-cancer treatments including chemotherapy, non-palliative radiotherapy, biological agents and immunomodulating agents, systemic immunosuppressive agents, including systemic corticosteroids); 21. The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare survival rate at 12 months in Vx-001 treated vs placebo treated patients.;Secondary Objective: The secondary objectives are: • Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients, • Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients ;Primary end point(s): The primary objective is to compare survival rate in Vx-001 treated vs placebo treated patients.;Timepoint(s) of evaluation of this end point: 12 months from start of therapy with IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients, • Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients ;Timepoint(s) of evaluation of this end point: •Death of patient •Progression of disease - onset of 2nd line therapy | — |
Countries
Czech Republic, Germany, Greece, Italy, Spain
Contacts
Public ContactKostas Kosmatopoulos
Vaxon Biotech
Outcome results
None listed