Conditions: Non-Small-Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung
Keywords: lung cancer NSCLC lung neoplasms respiratory
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 141
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).

Detailed description:

Arms:
arm 1: Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. arm 2: Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. arm 3: Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. arm 4: Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. arm 5: Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.

Interventions: intervention 1: Entinostat intervention 2: Placebo intervention 3: Erlotinib
Intervention descriptions: intervention 1: Entinostat tablets on Days 1 and 15 of a 28-day cycle. intervention 2: Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle. intervention 3: Erlotinib 150 mg tablets once daily.

Protocol document: