Vaxira as adjuvant treatment for non-small cell lung cancer

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000207
• Date of registration: 15/12/2015
• Prospective Registration: Yes
• Primary sponsor: National Institute of Oncology and Radiobiology (INOR)
• Public title: Vaxira as adjuvant treatment for non-small cell lung cancer
• Scientific title: Open randomized controlled clinical trial in patients with non-small cell lung cancer, stage IB, II and IIIA, treated or not with VAXIRA®, after surgery and adjuvant cisplatin-based chemotherapy
• Date of first enrolment: 20/12/2015
• Target sample size: 120
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000207-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: No intervention. Assignment: Parallel. Purpose: Treatment
• Phase: 2-3

Countries of recruitment

Cuba

Contacts

• Name: Maurenis Hernandez Pérez
• Affiliation: Center of Molecular Immunology

• Name: Maurenis Hernandez Perez
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion criteria

Inclusion criteria: 1-Male and female patients = 18 years with tumors in non-small cell lung and pathologically proven completely resected stage IB, II or IIIA stages.
2-Patients who have signed informed consent for research.
3-Patients where surgical technique for tumor resection patient has been anatomical, involving at least a lobectomy .
4-Patients in the mediastinal lymph node sampling has been carried out by radical mediastinal lymphadenectomy corresponding compartment.
5-Disease-free patients (locoregional metastases or relapse), confirmed by a negative CT study at baseline chest CT scan, upper abdomen and brain CT or MRI.
6-Patients with performance status 0-2 according to ECOG scale.
7-Patients who received adjuvant chemotherapy after surgery, have been completed or not all cycles.
8-Patients who have then received adjuvant chemotherapy, radiotherapy treatment option in accordance with pN.
9-Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed 2 months.
10-Patients with hepatic, renal and haematological normal functions defined by:
-Hemoglobina >= 10 g / L
Leukocyte - Total count >= 3.0 x 109 / L
Absolute Neutrophil -Count >= 1.5 x 109 / L
Platelet -Count >=100 x 109 / L
-Bilirubin To the upper limit of normal.
-TGP And TGO: up 1.5 times the upper limit of normal value of the institution, or <5 times the upper limit of normal value of the institution, if known the existence of liver metastases.
-Fosfatasa Alkaline =< 2.5 times the ULN.
-Creatinina: Within normal limits or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.
Exclusion criteria: 1- Stage IIIA patients who received neoadjuvant chemotherapy before surgery.
2- Patients whose primary tumor was removed by segmentectomy or wedge resection.
3- Patients showing any microscopic evidence of residual tumor after surgery (positive BSQ).
4- Patients who have previously received treatment with VAXIRA® vaccine or other immunotherapy.
5- Patients with previous history of cancer, except nonmelanoma skin tumors or carcinoma in situ of the cervix treated properly.
6- Patients with acute infectious diseases, chronic inflammatory or unbalanced.
7- Patients of childbearing age who do not accept use appropriate contraception (intrauterine devices, barrier methods or tubal ligation, hormonal methods).
8- Patients pregnant or breastfeeding.
9- Patients with acute allergic conditions or history of severe allergic reactions.
10- Patients who have received organ grafts.
11- Patients with psychiatric illness or addiction problems that may compromise their ability to give informed consent or to comply with trial procedures.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Lung Diseases

Non-Small Cell Lung Cancer (NSCLC)

Bronchial Neoplasms

Respiratory Tract Neoplasms

Carcinoma, Bronchogenic

Respiratory Tract Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Thoracic Neoplasms

Intervention(s)

Cancer Vaccines

Study group (Vaccine): VAXIRA®. The patient will receive 1mg/dose by intradermal route. The first five doses every 14 days and every 28 days during two years. After that, the vaccine will be administered every two months if patients general condition allows.

Control group: No treatment, only observation

Vaxira adjuvant

Primary Outcome(s)

Disease-free survival (DFS is defined as the time from randomization until recurrence of tumor or death from any cause). Measuring time: every 3 months during 5 years

Secondary Outcome(s)

Overall survival (Time from randomization until death from any cause). Measuring time: 5 years
Adverse events (Description of any adverse event using CTCAE version 4). Measuring time: in every administration during 5 years.
Quality of Live (Questionnaire developed by INOR: CV-INOR- 26-(V.01)). Measuring time: at baseline and every 3 months during 5 years.
Immune response: antibody titers against neu GcGM3 (It will be positive when the inverse of the highest serum dilution giving optical density = 0.25 and twice the value of the pre-immune serum). Measuring time: at baseline and every 3 months during 5 years.
Ability to lyse ganglioside expressing cells (It will be positive if percentage of dead cells =20 %, after subtracting the pre-immune to hyper-immune percent). Measuring time: at baseline and every 3 months during 5 years.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Cuban Public Ministry of Health (MINSAP)

Secondary Sponsor(s)

Center of Molecular Immunology (CIM)