Genmab A/S has initiated a phase II study of HuMax-EGFr (zalutumumab) in combination with chemo-radiation to treat non small cell lung cancer (NSCLC). The study will include a maximum of 270 previously untreated patients with advanced NSCLC.
"We are excited to expand the HuMax-EGFr program into this new indication and hope that it may some day prove to be an effective treatment for lung cancer patients," said Lisa N. Drakeman, chief executive officer of Genmab.
This open label study consists of two parts. Part 1 will include at least 24 patients divided into two sequential treatment groups. Patients in Group A will receive 2 cycles of induction chemotherapy in combination with weekly fixed doses of 8 mg/kg of HuMax-EGFr followed by 7 weekly 8 mg/kg doses of HuMax-EGFr in combination with radiotherapy. Pending satisfactory evaluation of safety data from Group A, patients in Group B will receive 2 cycles of induction chemotherapy in combination with HuMax-EGFr at individually titrated doses up to 16 mg/kg, based on the degree of skin rash the patient develops.