Identification of potential predictors and surrogates for the selection of patients who may benefit from the use of Racotumomab, as switch maintenance therapy, in patients with non-small cell lung cancer, stages IIIA, IIIB and IV.

Center of Molecular Immunology (CIM)0 个研究点开始时间: 2018年7月9日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1-Patients who meet the diagnostic criteria.
•2-Patients older than or equal to 18 years old.
•3-Patients who have signed the informed consent for the investigation.
•4-Patients with clinical status according to ECOG from 0 to 2.
•5-Patients who have received first-line treatment and reached at least stable disease in response.
•6-Patients in which the time between the end of the onco-specific treatment and the inclusion in the study is 4 to 6 weeks.
•7-Patients with life expectancy of six months or more.
•8-Patients with normal hepatic, renal and hematological functions defined by:
•Hemoglobin greater or equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion)
•Total Leukocyte Count greater or equal to 3.0 x 109 / L
•Absolute Neutrophil Count greater or equal to 1.5 x 109 / L
•Platelet Count greater or equal to 100 x 109 / L
•Bilirubin up to the normal upper limit.
•TGP and TGO: greater or equal to 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 or equal to 2.5 times the normal upper 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.

•1-Patients who have previously received treatment with the anti-idiotypic vaccine Racotumomab.
•2- Patients with acute, chronic, or inflammatory decompensated infectious diseases.
•3- Patients of childbearing age who do not accept 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 who are receiving any other product under investigation.
•7- Patients with brain metastasis.
•8- Patient with other malignant diseases.

发起方

Center of Molecular Immunology (CIM)