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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

RANIDO

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.

Acronym of Scientific Title:

RANIDO

Secondary indentifying numbers:

IICRDEC-147

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

11/12/2012

Reference number:

05-020-12B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Eduardo

Midle name:

Rafael

Last name:

Santiesteban

Medical Specialty :

Oncology

Affiliation:

Jose Ramon Lopez Tabrane

Postal address:

Santa Rita, bet/Santa Cecilia and San Isidro, Versalles, Matanzas

City:

Matanzas

Country:

Cuba

Zip Code:

40100

Telephone:

+53-45261929

Email address:

ensayohosprov.mtz@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Hermanos Ameijeiras Hospital, Elia Neninger, MD. Oncologist

Villa Clara, Celestino Hernnadez Robau Hospital, Ramon A. Carrodeguas, MD. On cologist

Santiago de Cuba, Saturnino Lora Hospital, Soraida Acosta, MD. Internal Medicine

Granma, Celia Sanchez Manduley Hospital, Gustavo Pichs, MD. Oncologist

Pinar del Rio, III Congreso Hospital, Rosa M. Amador, MD. Oncologist

Cienfuegos, Gustavo Aldereguia Hospital, Ivian Iglesias, MD. Oncologist

Havana, National Institute of Oncology and Radiobiology, Yoana Flores, MD. Onoclogist

Research ethics committees:

Jose Ramon Lopez Tabrane, december 18, 2012

Hermanos Ameijeiras, october 19, 2012

Celestino Hernnadez Robau, january 1, 2013

Saturnino Lora Hospital, august 31, 2012

Celia Sanchez Manduley, october 25, 2012

III Congreso Hospital, november 1, 2012

Gustavo Aldereguia, december 15, 2012

National Institute of Oncology and Radiobiology, june 6, 2013

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

11/02/2013

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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 patient's 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 patient's 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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

3

Target sample size:

670

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maurenis

Last Name:

Hernandez-Perez

Specialty:

Specialist of first degree in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 street and 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-214-3146

Email :

maurenis@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maurenis

Last Name:

Hernandez-Perez

Specialty:

Specialist of first degree in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 street and 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537 214-3146

Email :

maurenis@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000179

Date of Registration in Primary Registry:

26/05/2014

Record Verification Date:

2014/05/26

Next update date:

2015/05/26

Link to the spanish version:

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

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