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

Phase 2

• Conditions: on-Small Cell Lung Cancer (NSCLC) stage III inoperable; Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000295
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (Time from randomization until death from any cause). Measurement time: until 24 months.