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Safety and efficacy of VAXIRA® in advanced NSCLC patients not progressing after first line chemotherapy. Phase III.
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1 October 2020 - 11:50am
by Gladys
19 July 2023 - 3:20pm
by Gladys
Changes to
Name of Research Ethics Committees
-
University Hospital
“Celestino
Hernandez
Robau”
+
University Hospital
"Celestino
Hernandez
Robau"
Changes to
Record Verification Date
-
2020/10/
01
+
2020/10/
05
Changes to
Next update date
-
2021/10/
01
+
2021/10/
05
Revision of 19 July 2023 - 3:20pm:
Safety and efficacy of VAXIRA® in advanced NSCLC patients not progressing after first line chemotherapy. Phase III.
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Multicentric, randomized, open, parallel, compared clinical trial in advanced NSCLC patients who respond or have sta ble disease (not progressors) after first line-chemotherapy, treated with VAXIRA® or Nimotuzumab as switch maintenance therapy.
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Reference number:
In process
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Sailyn
Last name:
Alfonso Aleman
Medical Specialty :
First Degree Specialist in Oncology
Affiliation:
University Hospital “Celestino Hernandez Robau”
Postal address:
569 Cuba Street between Hospital and Alejandro Oms, Santa Clara
City:
Villa Clara
Country:
Cuba
Zip Code:
50100
Telephone:
+53-42271792
Email address:
sailyn@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
30/11/2020
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Lung Cancer
Health condition(s) code:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Health condition keyword:
Intervention(s):
Intervention group (VAXIRA®): 1mg, intradermic. Treatment duration: 15 doses, the first five immunizations will be administered every 14 days and the rest will be administered every 28 days during 1 year while patient’s conditions allow it. Control group (Nimotuzumab): 200 mg in 250 ml of saline solution administered intravenously (ante cubital vein). The first 6 doses will be administered weekly, with maintenance dose every 2 weeks during 1 year while patient’s conditions allow it.
Intervention code:
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Drug Therapy
Injections, Intradermal
Administration, Intravenous
Intervention keyword:
Nimotuzumab, VAXIRA
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Overall Survival (Time from randomization until death or date of last news). Measurement time: monthly for 1 year.
Key secondary outcomes:
1. Quality of life (EORTC QLQ-C30 y QLQ-LC13). Measurement time: inclusion, every 3 months for a year. 2. Toxicity (Measurable by: occurrence of any AE (Yes/No)-Description of the AE (Name of the adverse event)-Duration of the AE (difference between the initial date and the termination date of the AE)-Intensity of the AE (1. Mild, 2. Moderate, 3. Severe, 4. Extremely severe, 5. Death)-Severity (1. Serious, 2. No serious)-Result (1. Recovered, 2. Enhanced, 3. Persists or Squeals)-Attitude towards treatment (1. Unchanged, 2. Dose modification, 3. Temporary interruption, 4. Definitive interruption)-Causality relationship (1. Very likely/sure/definitive, 2. Probable, 3. Possible, 4. Unlikely, 5. Not related, 6. Not evaluable/unclassified). Measurement time: monthly during 1 year. 3. Humoral Immune Response (measurable by: Ab response against VAXIRA (yes, no)-Response against NGGM3 (yes no)-Response against tumor antigens (yes/no; response-generating antigen). Measurement time: every three months for 1 year. 4. Cellular immune response (Measurable by: level of subpopulations (in %)-T lymphocyte mitogen activation capacity (in %). 5. Level of inflammatory cytokines: (in pg/mL). Measurement time: baseline and then every three months for 1 year. 6. Baseline EGF concentration (in pg/mL). Measurement time: baseline and then every three months for a year. 7. EGFR expression (Measurable by crosses: mild (+), moderate (++), high (+++), none (0). Measurement time: before starting treatment. 8. Biochemical parameters (measured by: hemoglobin (g/L)-leukogram with differential (cells/L), hematocrit (%)-platelets (-TOG (UI/L)-TGP-(UI/L)-bilirrubine (mg/dL)-glucose (mg/dL)-alkaline phostatase (UI/L), LDH (UI/L)-creatinine (mg/dL). Measurement time (baseline and then every three months for a year). 9. Objective Response (According to RECIST v. 1.1 criteria classified as Complete Response, Partial Response, Stable Disease, or Progressive disease). Measurement time: every three months for 1 year.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
None
Inclusion criteria:
1. Patients who meet the diagnostic criteria. 2. Patients with tumor response (total or partial) or stable disease after the first line of oncospecific treatment. 3. Patients aged 18 or more. 4. Patients who have signed informed consent. 5. Serum EGF concentration <870 pg/mL. 6. Patients with clinical status according to ECOG of 0 to 2. 7. Patients with an interval between the end of the oncospecific treatment and the inclusion in the study not exceeding 2 months and the time between response evaluation and time to inclusion not exceeding 1 month. 8. Patients with a life expectancy of 6 months or more. 9. Patients with organs and bone marrow functioning defined by the following parameters: Hemoglobin ≥ 90 g/L (patients with lower Hb level should be transfused prior to inclusion), Total Leukocyte Count ≥3.0 x 109/L, Neutrophil Absolute Count ≥ 1.5 x 109/L, Platelet Count ≥100 x 109/L, Bilirubin: up to the upper normal limit , 14. TGP y GOT/GTP: up to 1.5 times the normal upper limit for each institution, or <5 times the upper normal limit for the institution, if the existence of liver metastases is known. 15. Alkaline phosphatase: Up to 2.5 times the normal upper limit for each institution. 16. Creatinine: within normal limits for each institution or creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above normal values for the institution.
Exclusion criteria:
1. Patients with previous history of use of anti idiotipic vaccine 1E10 and/or Nimotuzumab. 2. Patients carrying uncontrolled acute infectious diseases, chronic diseases, or inflammatory diseases. 3. Patients with fertile age who don’t accept to use proper anticonceptives methods (intrauterine devices, barrier methods or tubal ligation, hormonal methods). 4. Patients who are pregnant or breastfeeding. 5. Patients with acute allergic states or with history of severe allergic reaction. 6. Patients who are not tributary of oncospecific treatment. 7. Patients with brain metastases.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Open
Control group:
Active
Study design:
Parallel
Phase:
3
Target sample size:
264
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Geydi
Last Name:
Lorenzo Monteagudo
Specialty:
Pharmaceutics Sciences. MSc. Toxicology.
Affiliation:
Center of Molecular Immunology
Postal Address:
216 street corner to 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
11600
Telephone:
+53-42271792
Email :
geydi@cim.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Geydi
Last Name:
Lorenzo Monteagudo
Specialty:
Pharmaceutics Sciences. MSc. Toxicology
Affiliation:
Center of Molecular Immunology
Postal Address:
216 street corner to 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
11600
Telephone:
+53-42279401
Email :
geydi@cim.sld.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
University Hospital "Celestino Hernandez Robau"
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
17/09/2020
Postal address of Ethic Committee :
Calle Cuba No 569 e/ Hospital y Alejandro Oms, Santa Clara, Villa Clara. Cuba
Telephone:
+53-42271202
Email:
sailyn@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Study completion date:
29/07/2023
Date of available results:
01/03/2024
Date of first publication:
01/06/2024
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000336
Date of Registration in Primary Registry:
01/10/2020
Record Verification Date:
2020/10/05
Next update date:
2021/10/05
Link to the spanish version:
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