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Biomodulina T- CIMAvax-EGF-Advanced Non-Small Cell Lung Cancer-Adults

Assessment of the impact of Biomodulina T at the conclusion of first-line chemotherapy in patients diagnosed with non-small cell lung cancer, on the proportion of CD4+ T cells and terminally differentiated CD8+CD28 T cells, as well as the evaluation of these cell populations as possible biomarkers of the CIMAvax-EGF vaccine efficacy - BT- CIMAvax-EGF-NSCLC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000358
Enrollment
Unknown
Registered
2021-03-18
Start date
2019-02-21
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Experimental group: Biomodulina T + CIMAvax-EGF Biomodulina T: It will be administered 3mg intramuscular, 3 times per week (9mg per week) will be administered for 4 weeks. At the end of treatment with
Immunotherapy, Active
Immunologic Factors
Immunomodulation
Epidermal Growth Factor
Cyclophosphamide
Injections, Intramuscular
Biomodulin T, CimaVax-EGF

Sponsors

Center of Molecular Immunology (CIM)
Lead Sponsor
National Center for Bioproducts (BioCen)
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients of any sex and age over or equal to 18 years old. 2. Patients diagnosed with cyto/histological carcinoma of non-small lung cells in all stages IIIb and IV 3. Patients who have signed informed consent for research 4. Patients with clinical status criteria (ECOG) from 0 to 2

Exclusion criteria

Exclusion criteria: 1. Patients of childbearing potential who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In case of male sex (vasectomy, condom use) for the duration of treatment. 2. Pregnant, lactating or post-breastfeeding patients.

Design outcomes

Primary

MeasureTime frame
1. Subpopulations of T lymphocytes (CD4 + CD28-, TCD8 + CD28- and CD19 + IgD-CD27-, all values are expresed in percent). Measurement time: before and after platinum-based chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine. 2. Titer of Ab anti EGF (inverse of the last dilution in which a higher O.D. than the average of the blanks was obtained). Measurement time: at the end of chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine. 3. EGF concentration (measured in pg / ml). Measurement time: at the end of chemotherapy, at the end of the administration of Biomodulin T, at 3, 6 and 12 months of administration of the Cimavax-EGF vaccine.—

Secondary

MeasureTime frame
Survival time (Time from inclusion until death) Measurement time: every year for two years from inclusion.—

Countries

Cuba

Contacts

Public ContactDanay Saavedra Hernandez

Center of Molecular Immunology (CIM)

danays@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026