Multicentric, randomized, open, parallel, compared clinical trial in advanced NSCLC patients who respond or have sta ble disease (not progressors) after first line-chemotherapy, treated with VAXIRA® or Nimotuzumab as switch maintenance therapy.

Center of Molecular Immunology (CIM)0 个研究点目标入组 264 人开始时间: 2020年10月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•1. Patients who meet the diagnostic criteria.
•2. Patients with tumor response (total or partial) or stable disease after the first line of oncospecific treatment.
•3. Patients aged 18 or more.
•4. Patients who have signed informed consent.
•5. Serum EGF concentration <870 pg/mL.
•6. Patients with clinical status according to ECOG of 0 to 2.
•7. Patients with an interval between the end of the oncospecific treatment and the inclusion in the study not exceeding 2 months and the time between response evaluation and time to inclusion not exceeding 1 month.
•8. Patients with a life expectancy of 6 months or more.
•9. Patients with organs and bone marrow functioning defined by the following parameters: Hemoglobin = 90 g/L (patients with lower Hb level should be transfused prior to inclusion), Total Leukocyte Count =3.0 x 109/L, Neutrophil Absolute Count = 1.5 x 109/L, Platelet Count =100 x 109/L, Bilirubin: up to the upper normal limit , 14. TGP y GOT/GTP: up to 1.5 times the normal upper limit for each institution, or <5 times the upper normal limit for the institution, if the existence of liver metastases is known. 15. Alkaline phosphatase: Up to 2.5 times the normal upper limit for each institution. 16. Creatinine: within normal limits for each institution or creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above normal values for the institution.

•1. Patients with previous history of use of anti idiotipic vaccine 1E10 and/or Nimotuzumab.
•2. Patients carrying uncontrolled acute infectious diseases, chronic diseases, or inflammatory diseases.
•3. Patients with fertile age who don’t accept to use proper anticonceptives methods (intrauterine devices, barrier methods or tubal ligation, hormonal methods).
•4. Patients who are pregnant or breastfeeding.
•5. Patients with acute allergic states or with history of severe allergic reaction.
•6. Patients who are not tributary of oncospecific treatment.
•7. Patients with brain metastases.

发起方

Center of Molecular Immunology (CIM)