Nimotuzumab has been studied in 9 clinical trials in NPC indication involving a total of 484 patients in Germany, Canada, Cuba and Brazil. There are now 2 ongoing studies in China and Cuba involving more than 102 patients as of 2017.

For a complete publication and list of clinical trial on nimotuzumab in Glioma please contact us here.

Below is an excerpt from a study in China as presented at ASCO (2016), publication of completed study in process: Solomón, M. T. eres. et al. Radiotherapy plus nimotuzumab or placebo in the treatment of high-grade glioma patients: results from a randomized, double blind trial. BMC Cancer 13, 299 (2013).


Disease state

High-grade gliomas (HGGs) include glioblastoma multiforme and anaplastic astrocytomas. These tumours account for nearly 55% of all gliomas. Well-differentiated astrocytomas constitute between 25% and 30% of cerebral gliomas.

Less than one fifth of all patients with untreated glioblastomas survive for 1 year after the onset of symptoms, and only about 10% live beyond 2 years.

Age is the most important prognostic factor with less than 10% of patients more than 60 years of age surviving for 18 months as compared to nearly two thirds of those below 40 years.

Epidermal growth factor receptor (EGFR) is over-expressed in >50% glioblastoma.


Study Design

This was a Phase III, controlled, randomized, double blind study to evaluate the efficacy of nimotuzumab combined with radiotherapy compared to radiotherapy plus placebo in patients with high-grade glioma.

  • Nimotuzumab: 200 mg of nimotuzumab (iv) weekly for 6 weeks concomitantly with radiotherapy, followed by 200 mg of nimotuzumab every 21 days for a year
  • Placebo: saline solution was given at the same manner as nimotuzumab
  • Radiotherapy: 180–200 cGy given once daily, 5 days per week, for 6 weeks

Glioma Study Design


  • Nimotuzumab in Combination with Radiotherapy Significantly Improve Patients’ Survival, Especially Those with Anaplastic Astrocytoma

Glioma Study Design

  • Nimotuzumab was safe and did not exaggerate radiation-related toxicities.
    • Grade 1-2 infusion reactions were the most common adverse events observed in this study.
    • Nimotuzumab showed low-immunogenicity as there was no anti-idiotypic response observed.

Glioma Study Design