A Randomized, Open-label, Japan-Korea Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer
This randomized, open-label, Japan and Korea collaborative, phase 3 study will evaluate
overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone
in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control
group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan
should be continued until disease progression or intolerable toxicity. Nimotuzumab is
administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered
at 150 mg/m2 once every 2 weeks as an intravenous infusion.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
Around 4.5 years after first subject randomization
Japan: Pharmaceuticals and Medical Devices Agency