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

Not Applicable

• Conditions: on Small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000270
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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