Conditions: Carcinoma Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer (NSCLC) Sorafenib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 703
Healthy volunteers: no

Brief summary:
The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Detailed description:
Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST).

Arms:
arm 1: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID) arm 2: Participants received 2 tablets of placebo orally twice daily (BID)

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily (BID) intervention 2: Placebo - 2 tablets twice daily (BID)

Protocol document: