Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer NSCLC Advanced Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer Lung Cancer Erlotinib Tarceva MM-121 ErbB3 Her3 Epidermal Growth Factor Receptor anti-ErbB3 human monoclonal antibody ErbB3 antagonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Detailed description:
Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Arms:
arm 1: Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO) arm 2: Erlotinib (daily) arm 3: MM-121 (QOW IV) and erlotinib (daily PO)

Interventions: intervention 1: MM-121 intervention 2: Erlotinib
Intervention descriptions: intervention 1: MM-121 (SAR256212) = intravenous solution intervention 2: erlotinib = daily oral tablet

Protocol document: