Combined NGcGM3/VSSP and Nimotuzumab in advanced non-small cell lung cancer (NSCLC)

Combined immunotherapy with the vaccine preparation NGcGM3/VSSP and the monoclonal antibody nimotuzumab, in patients with advanced non-small cell lung cancer (NSCLC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000270

Enrollment

Registered

2018-04-30

Start date

2018-04-30

Completion date

Unknown

Last updated

2026-03-30

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

Group A (patients with + NGcGM3 expression): NGcGm3/VSSP vaccine (subcutaneous), dose of 900µg, the first 5 immunizations every 14 days and the following immunizations every 28 days, up to 24 months G

G(M3) Ganglioside

Receptor, Epidermal Growth Factor

Antibodies, Monoclonal, Humanized

Gangliosides

Proteolipids

Antineoplastic Agents

Immunotherapy, Active

Adjuvants, Immunologic

Antineoplastic Combined Chemotherapy Protocols

Administration, Intravenous

Injections, Subcutaneous

NGcGM3/VSSP, Nimotuzumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with confirmed diagnosis of NSCLC 2. Patients who consent to participate in the study by signing the informed consent model. 3. Patients older than 18 years. 4.Clinical and radiological documentation the evaluation of the response to the oncoespecific treatment of 1st line 5. Partial or stable response (RECIST), at the end of the first-line onco-specific treatment.6.Patients with + expression of EGF-R and / or NGcGM3 7.Patients with ECOG scale of Performance Status = 2. 8.Life expectancy at least 6 month 9. Time from the end of first-line oncospecific therapy to inclusion, no longer than 2 months 10. Patients with normal functioning of organs and bone marrow defined by laboratory parameters - Hemoglobin >9 g/L, - White blood cell (WBC) count > 3000/ µL, - Neutrophils = 1.5 x 109/L , - Platelet count = 100,000 per µL, - Total bilirubin: in normal labs values, - AST and ALT = 2.5 x upper limit of normal (ULN), - Serum creatinine in normal labs values, - Glycemia: in normal labs values

Exclusion criteria

Exclusion criteria: 1.Patients with fertile age. 2. Pregnancy, lactation or puerperium. 3. Patients with history of severe allergy disease. 4. Patients who have been treated with NGcGm3/VSSP, nimotuzumab or some other EGF-R blocker. 5. Patients with descompensated chronic diseases. 6. patients with previous demyelinating and inflammatory diseases 7. Patients with previous malignancies, except carcinoma in situ of cervix or skin cancer (non-melanoma), correctly treated 8. Patients with acute or chronic infectious diseases 9. Patients with brain metastases.

Design outcomes

Primary

Measure	Time frame
Overall Survival (Time from randomization-recruitment until death from any cause). Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months.	—

Secondary

Measure	Time frame
Related to Security Adverse Events-AE. Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months. AE will be measured as: - Occurrence of any AE (Yes or No). - Duration AE (Difference of dates between the start and end AE). - Type AE: (Description AE according to CTCAE, 4.0). - Intensity AE (According to CTCAE, 4.0 as Mild, Moderate, Severe, Serious that Life-threatening or incapacitates the subject, Death). - serious AE (Serious or not serious) - Attitude towards the drug (Modification of the dose, temporary interruption, definitive interruption of the treatment). - Result AE (Recovered, improved, persists or leaves sequels). - Causal relationship (very probable, probable, possible, improbable, unrelated, non-assessable) - Treatment indicated (Treatment received by the patient for the submitted AE). Results of laboratory tests measured in numerical values (hemoglobin, leukogram with differential, CAN, platelet count, TGP, GOT, creatinine, glycemia, alkaline phosphatase, total bilirubin). Measurement time: at the beginning, every 3 months during the treatment. Prior to each cycle of chemotherapy (2nd line) Related to the effect: Objective response - OR (According to RECIST, classified as a partial response, stable disease or progressive disease). Measurement time: at the beginning, 3, 6, 9, 12, 15, 18, 21, 24 months. Progression-free survival-PFS (Time from the date of inclusion of each patient until date of progression). Measurement time: 24 months. Duration of the objective response (It will be measured using the RECIST). Measurement time: 24 months Immunological response measured as. - Response of IgM and IgG isotype antibodies against ganglioside NGcGM3 (Measurement: Ac title). Measurement time: at baseline, 3, 6 12 months. - Recognition and lytic capacity of IgM and IgG antibodies, induced by vaccination and directed to NGcGM3, on tumor lines expressing the ganglioside. [Measurement:%, greater than 20% cellular in the line that expresses the ganglioside (L1210)].	—

Measure

Time frame

Related to Security Adverse Events-AE. Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months. AE will be measured as: - Occurrence of any AE (Yes or No). - Duration AE (Difference of dates between the start and end AE). - Type AE: (Description AE according to CTCAE, 4.0). - Intensity AE (According to CTCAE, 4.0 as Mild, Moderate, Severe, Serious that Life-threatening or incapacitates the subject, Death). - serious AE (Serious or not serious) - Attitude towards the drug (Modification of the dose, temporary interruption, definitive interruption of the treatment). - Result AE (Recovered, improved, persists or leaves sequels). - Causal relationship (very probable, probable, possible, improbable, unrelated, non-assessable) - Treatment indicated (Treatment received by the patient for the submitted AE). Results of laboratory tests measured in numerical values (hemoglobin, leukogram with differential, CAN, platelet count, TGP, GOT, creatinine, glycemia, alkaline phosphatase, total bilirubin). Measurement time: at the beginning, every 3 months during the treatment. Prior to each cycle of chemotherapy (2nd line) Related to the effect: Objective response - OR (According to RECIST, classified as a partial response, stable disease or progressive disease). Measurement time: at the beginning, 3, 6, 9, 12, 15, 18, 21, 24 months. Progression-free survival-PFS (Time from the date of inclusion of each patient until date of progression). Measurement time: 24 months. Duration of the objective response (It will be measured using the RECIST). Measurement time: 24 months Immunological response measured as. - Response of IgM and IgG isotype antibodies against ganglioside NGcGM3 (Measurement: Ac title). Measurement time: at baseline, 3, 6 12 months. - Recognition and lytic capacity of IgM and IgG antibodies, induced by vaccination and directed to NGcGM3, on tumor lines expressing the ganglioside. [Measurement:%, greater than 20% cellular in the line that expresses the ganglioside (L1210)].

—

Countries

Cuba

Contacts

Public ContactPedro Guerra Chaviano

National Coordinating Center of Clinical Trials (CENCEC)

pedrop@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026