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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000179

Enrollment

670

Registered

2014-05-26

Start date

2013-02-11

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

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 patient's general condition permi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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.

Design outcomes

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Primary

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

Countries

Cuba

Contacts

Public ContactMaurenis Hernandez-Perez

Center of Molecular Immunology

maurenis@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026