Safety and efficacy of VAXIRA® in advanced NSCLC patients not progressing after first line chemotherapy. Phase III.

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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

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

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:

2020/10/01

Next update date:

2021/10/01

Link to the spanish version:

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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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