The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
1.2mL of conjugate-adjuvant mix injection at four sites during the Post First-Line Chemotherapy. Reduced dose of injection at two sites during the Pre-Progression Phase.
"Multiprofile Hospital for Active Treatment (MHAT)-Dobrich" AD
Dobrich, Bulgaria
MHAT for Women's Health-Nadezhda"OOD
Sofia, Bulgaria
Nemocnice Na Pleši s.r.o. Oddelení klinické onkologie a radioterapie
Nová Ves pod Pleší, Czechia
Pardubická krajská nemocnice, a.s.c
Pardubice, Czechia
Thomayerova nemocnice
Prague, Czechia
Overall Survival (OS)
To assess overall survival (OS) of an EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R, NSCLC patients compared to the control group receiving best treatment and supportive care. OS is defined as the time from randomisation to death due to any cause.
Time frame: Each patient will be followed till death occurs within study time frame of 3 years
Safety of EGF Cancer Vaccine as assessed by Adverse Events (AEs)
To assess the frequency and number of patients develop AEs, related AEs, serious AEs (SAEs) and AEs leading to withdrawal or death
Time frame: Each patient will be followed till death occurs within study time frame of 3 years
Progression-Free Survival (PFS)
Progression parameters include radiological or clinical progression, withdrawal due to progression, and death due to any cause.
Time frame: Each patient will be followed till objective tumour progression or death (whichever occurs first) within time frame of study of 3 years
Survival Rate
To assess the percentage of patients that are alive at 12 months and 24 months in EGF cancer vaccine study group compared to control group.
Time frame: Each patient will be followed at 12 and 24 months after randomization
Time to Progression (TTP)
To assess Time to Progression (TTP) from the time of randomisation to first documented disease progression of EGF cancer vaccine study group patients compared to control group.
Time frame: Each patient will be followed till observed tumour progression within study time frame of 3 years
Response Rate (RECIST criteria)
To assess the percentage of patients with a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria Version 1.1.
Time frame: Each patients will be followed till death occurs within study time frame of 3 years
Safety of EGF Cancer Vaccine by Laboratory Assessment
To assess haematology, biochemistry and urinalysis parameters
Time frame: Each patients will be followed till death occurs within study time frame of 3 years
Safety of EGF Cancer Vaccine assessed by Vital Signs
To assess systolic and diastolic blood pressure, body temperature and pulse rate
Time frame: Each patients will be followed till death occurs within study time frame of 3 years
Safety of EGF Cancer Vaccine as assessed by Physical Examination
To assess eyes, neurological and cardiovascular systems, lungs, abdomen, and any other areas with signs and symptoms of disease, and of the head, neck, ears, nose, mouth, throat, thyroid, lymph nodes and extremities
Time frame: Each patient will be followed till death occurs within study time frame of 3 years
Quality of Life (QoL)
To assess the general physical health of patients with a 36-item, short-form health survey until disease progression
Time frame: Each patient will be followed till death occurs within study time frame of 3 years
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Cancer Center of Adjara
Batumi, Georgia
Clinic Health House
Tbilisi, Georgia
Institute of Clinical Oncology
Tbilisi, Georgia
JSC, Maritime Hospital
Tbilisi, Georgia
JSC, Neo Medi
Tbilisi, Georgia
...and 41 more locations