Conditions: Non Small Cell Lung Cancer
Keywords: Lung Cancer Previously Treated Advanced Non Small Cell Lung Cancer Erlotinib Pazopanib
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 202
Healthy volunteers: no

Brief summary:
This randomized, placebo-controlled, Phase II trial will compare the combination of erlotinib with pazopanib (providing concurrent EGFR and VEGFR inhibition) with erlotinib alone in the second- or third-line treatment of patients with advanced NSCLC. This study will be conducted though the Sarah Cannon Research Consortium, a community-based clinical trial network.

Detailed description:
Erlotinib is the current treatment standard for second- or third-line therapy of advanced NSCLC. Since angiogenesis inhibitors have also shown activity in NSCLC, the simultaneous inhibition of the EGFR and VEGF pathway may improve the efficacy of therapy. In a recently reported Phase III trial (Hainsworth et al. 2008), the combination of bevacizumab and erlotinib improved the Progression- Free-Survival (PFS) vs. erlotinib alone when given as second-line therapy in NSCLC (3.4 months vs. 1.7 months, respectively; HR 0.63). Pazopanib also inhibits the angiogenesis pathway, and may have advantages over bevacizumab including: (1) inhibition of other potentially important targets, including PDGFR; and (2) more convenient oral administration.

Arms:
arm 1: Erlotinib: 150 mg orally daily

Pazopanib: 600 mg orally daily arm 2: Erlotinib: 150 mg orally daily

Placebo: orally daily

Interventions: intervention 1: Pazopanib intervention 2: Erlotinib
Intervention descriptions: intervention 1: Pazopanib: 600 mg orally daily intervention 2: Erlotinib: 150 mg orally daily

Protocol document: