This open-label Phase II single-arm study is enrolling patients with stage IIIB or IV non-small cell lung cancer. Approximately 40 patients are expected to be enrolled. This study is designed to evaluate the progression-free survival rate at six months of IMC-1121B in combination with paclitaxel and carboplatin, each administered as an intravenous infusion every three weeks, in this disease setting.
In addition to this Phase II study, disease-directed studies of IMC-1121B in patients with advanced melanoma, liver, renal, ovarian, and prostate cancers have begun to enroll patients, and additional Phase II and III evaluations are in various stages of development, the company said.
Eric Rowinsky, chief medical officer of ImClone, said: “We are very excited to start another disease-directed trial of IMC-1121B, particularly in non-small cell lung cancer, a disease that continues to be highest on the list of cancers responsible for morbidity and mortality.
“We also look forward to applying the preclinical and clinical insights that we have gained with our armamentarium of IgG1 antibodies directed against malignant angiogenesis to the treatment of non-small cell lung cancer.”