Nimotuzumab in Non-Small Cell Lung Cancer (NSCLC) of inoperable stage III epidermoid histology, concomitant with Chemo and Radiotherapy (CRT)

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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:

Nimotuzumab in NSCLC

Scientific title:

Phase II-III clinical trial, controlled, randomized, in parallel, adaptive design in two stages, compared, in patients with inoperable stage III epidermoid histology NSCLC, treated with concurrent CT-RT plus Nimotuzumab vs concurrent CT-RT.

Acronym of Scientific Title:

Nimotuzumab in NSCLC concomitant with CRT

Secondary indentifying numbers:

Not Applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Cuban 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)

Reference number:

In process

Principal investigator

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

First name:

Kirenia

Last name:

Camacho Sosa

Medical Specialty :

First degree specialist in Oncology.

Affiliation:

University Clinical Surgical Hospital Commander Faustino Perez Hernandez.

Postal address:

Carretera Central Km. 101.

City:

Matanzas

Country:

Cuba

Zip Code:

40100

Telephone:

+53-045276053

+53-045244324

Email address:

kireniac.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:

Pinar del Rio, Provincial Surgical Clinical Hospital III Congress, Barbara Iglesias Castillo, MD, Second Degree Specialist in Oncology.

Research ethics committees:

University Clinical Surgical Hospital Commander Faustino Perez Hernandez, June 11, 2018

Provincial Surgical Clinical Hospital III Congress, July 4th, 2018

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/02/2019

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 (NSCLC) stage III inoperable

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

First stage: It will be compound by one group of treatment Group I Nimotuzumab+Chemotherapy+Radiotherapy (experimental): Nimotuzumab 200 mg by intravenous route, diluted in 250 mL of 0.9% saline solution, once a week for 20 weeks, followed by administrations every 14 days until up to 24 months after start the treatment. The Chemotherapy by intravenous route will be compound by Cisplatin (50mg / m2) plus 500 ml of 0.9% saline (days 1, 8, 29,36) and, Etoposide (50mg / m2) plus 500ml 0.9% saline solution (days 1 to 5 and from 29 to 33). The thoracic radiotherapy (60 Gy) will be receive 2 Gy daily, 5 times a week for 6 weeks. Second stage: It will be compound by two group of treatments Group I Nimotuzumab+Chemotherapy+Radiotherapy (experimental): Nimotuzumab 200 mg by intravenous route, diluted in 250 mL of 0.9% saline solution, once a week for 20 weeks, followed by administrations every 14 days until up to 24 months after start the treatment. The Chemotherapy by intravenous route will be compound by Cisplatin (50mg / m2) plus 500 ml of 0.9% saline (days 1, 8, 29,36) and, Etoposide (50mg / m2) plus 500ml 0.9% saline solution (days 1 to 5 and from 29 to 33). The thoracic radiotherapy (60 Gy) will be receive 2 Gy daily, 5 times a week for 6 weeks. Group II Placebo+Chemotherapy+Radiotherapy (control): Scheme same to the group I, using placebo instead of Nimotuzumab

Intervention code:

Antibodies, Monoclonal, Humanized

Antibodies, Monoclonal

Drug Therapy

Radiotherapy

Chemoradiotherapy

Cisplatin

Etoposide

Antineoplastic Agents

Administration, Intravenous

Placebos

Intervention keyword:

Nimotuzumab

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 randomization until death from any cause). Measurement time: until 24 months.

Key secondary outcomes:

1. Quality of life (EORTC QLQ-C30 (v. 3) questionnaire). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months. 2.Adverse events-AE (Description of AE (Name of the AE); Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death); Seriousness of the AE (Serious, Not serious); Causality relationship (Very probable, Probable, Possible, Improbable, Not related, Not evaluable); Attitude towards treatment (Temporary interruption, Definitive interruption, Modification of doses, No change), Result of AE (Reversible effect, Irreversible effect, Death, Loss of follow-up)). Measurement time: until 24 months. 3. Antitumor response (It will be classified in Complete response, Partial response, Stable disease, Progressive disease according to RECIST criteria). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months. 4. EGF concentrations: (Values in pico grams using serum levels through an ELISA). Measurement time: at baseline, 3, 6, 9 and 12 months. 5. Values of platelet count (Absolute values from serum measurements). Measurement time: at baseline, 3, 6, 9 and 12 months. 6. Progression-Free Survival (Time from treatment start until objective tumor progression or death from any cause). Measurement time: until 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. Patients who meet the diagnostic criteria. 2. Patients with age greater than or equal to 18 years. 3. Patients who have signed the informed consent for the investigation 4. Patients with functional capacity according to ECOG from 0 to 1. 5. Virgin patients of oncospecific treatment. 6. Patients with life expectancy of more than six months. 7. Patients with normal hepatic, renal and hematologic functions defined by: • Hemoglobin greater than and equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion) • Total Leukocyte count greater than and equal to 3.0 x 109 / L • Absolute Neutrophil count greater than and equal to 1.5 x 109 / L • Absolute Eosinophil count with any value. • Concentrations of EGF with any value. • Platelet count greater and equal 100 x 109 / L • Bilirubin up to the normal upper limit. • TGP and TGO: up to and less than 1.5 times the upper limit for the normal value of the institution, or <5 times the upper limit for the normal value of the institution, if the existence of liver metastasis is known. • Alkaline phosphatase greater than and equal to 2.5 times the upper normal limit. • Creatinine: Within normal limits for each institution or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.

Exclusion criteria:

1. Patients who have previously received onco-specific treatment. 2. Patients with acute, chronic, or inflammatory decompensated infectious diseases. 3. Patients of childbearing age who do not accept to use adequate contraceptive methods (intrauterine devices, barrier or tubal ligation methods, hormonal methods). 4. Pregnant or lactating patients. 5. Patients with acute allergic states or history of severe allergic reactions. 6. Patients that are not tributaries of receiving onco-specific treatment. 7. 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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

Stage 1 (20 patients), Stage 2 (904 patients, 452 per group)

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:

Mayra

Last Name:

Ramos-Suzarte

Specialty:

PhD in Medicine. Biochemestry and Clinical Trials Specialistand. Nimotuzumab Project Manager

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15. Atabey

City:

Playa

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@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:

Mayra

Last Name:

Ramos-Suzarte

Specialty:

PhD in Medicine. Biochemestry and Clinical Trials Specialistand. Nimotuzumab Project Manager

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15. Atabey

City:

Playa

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@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:

RPCEC00000295

Date of Registration in Primary Registry:

28/12/2018

Record Verification Date:

2018/12/28

Next update date:

2019/12/28

Link to the spanish version:

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Nimotuzumab in Non-Small Cell Lung Cancer (NSCLC) of inoperable stage III epidermoid histology, concomitant with Chemo and Radiotherapy (CRT)

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