Racotumomab,Nimotuzumab or Docetaxel in the treatment of the advanced non-small cell lung cancer.

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000179
• Date of registration: 26/05/2014
• Prospective Registration: No
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Racotumomab,Nimotuzumab or Docetaxel in the treatment of the advanced non-small cell lung cancer.
• Scientific title: Multicenter clinical trial, randomized, stratified, open and compared in patients with advanced NSCLC treated with Racotumomab or Nimotuzumab, vs Docetaxel after first line treatment oncospecific. - RANIDO
• Date of first enrolment: 11/02/2013
• Target sample size: 670
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000179-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 3

Countries of recruitment

Cuba

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria: 1. Stage IIIB/IV cyto/hystological confirmed NSCLC.
2. 18 years of age or older.
3. Patients who signed informed consent for research.
4. Patients with clinical status of 0-2 according to ECOG.
5. Patients who have received at least two cycles of CT front line, and count on response assessment at the end of such treatment.
6.Patients in whom the end of oncospecific treatment and inlcusion in the study not exceeding 2 months for Non progressors stratum and 6 months for Progressors stratum.
7. Patients with a life expectancy of 6 months or more
8. Patients with hepatic, renal functions and normal hematologic fuctions.
Exclusion criteria: 1. Patients who have received prior treatment with racotumomab, nimotuzumab or docetaxel.
2. Patients with a history of severe hypersensitivity reactions to taxanes or other drugs formulated with polysorbate 80.
3. Patients with chronic or acute infectious diseases, or unbalanced inflammatory diseases .
4. Patients of childbearing age not using adequate contraception method.
5. Pregnant patients or nursing.
6. Patients with acute allergic states or history of severe allergic reactions.
7. Patients who are not candidates for oncoespecific treatment.
8. Patients with brain metastases.

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

Health Condition(s) or Problem(s) studied

Non small cell lung cancer

Intervention(s)

Group 1 (experimental arm) : Racotumomab (1mg) intradermally to complete 15 doses, the first five every 14 days and the remaining ten, every 28 days provided that the patients general condition permits.
Group 2 (experimental arm) : Nimotuzumab mAb (200 mg) intravenous (antecubital vein), in 250 ml of saline solution for 6 weeks with maintenance every 2 weeks if the patients general condition permits.
Group 3 (control arm): Docetaxel (75 mg/m2) subcutaneously every 3 weeks to complete 6 cycles.

Groups 1 and 2 will receive treatment in primary care and group 3 will receive treatment in secondary care.
Each group will have 2 strata of patients: progressors patients and non-progressors patients.

Primary Outcome(s)

Overall Survival (Time from inclusion to death). Measuring time: 24 months.

Secondary Outcome(s)

Quality of life (EORTC surveys, EORTC QLQ-C30 y QLQ-LC1). Measuring time: 24 months.
Toxicity (Description of adverse events using CTCAE v4). Measuring time: 24 months.
Objective Response (RECIST measurement v1.1.). Measuring time: 24 months.
Immune Response (antibody response against NGcGM3 and Racotumomab will be measured, the ability of recognition and analysis of these antibodies in a cell line expressing the ganglioside NGcGM3). Measuring time: 24 months.

Secondary ID(s)

IICRDEC-147

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable