Conditions: Lung Cancer Non-small Cell Lung Cancer
Keywords: Carcinoma Non-Small-Cell Lung Lung Neoplasms Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Erlotinib Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 145
Healthy volunteers: no

Brief summary:
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.

Detailed description:

Arms:
arm 1: Placebo infusion every 3 weeks and oral erlotinib 150 mg/day arm 2: Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day

Interventions: intervention 1: Patritumab intervention 2: Erlotinib intervention 3: Placebo
Intervention descriptions: intervention 1: Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) intervention 2: Oral erlotinib 150 mg/day intervention 3: Placebo infusion every 3 weeks

Protocol document: