Phase III study comparing Sorafenib to placebo in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens f...

Update Il y a 5 ans
Reference: EUCTR2008-006914-62

Phase III study comparing Sorafenib to placebo in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens for advanced disease

Woman and Man

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Extract

The objective of this phase III study is to compare the efficacy and safety of sorafenib monotherapy plus best supportive care (BSC) versus placebo plus BSC for the treatment of patients with relapsed or refractory advanced predominantly non squamous NSCLC after 2 or 3 prior treatment regimens for advanced disease. The primary efficacy variable is overall survival (OS).


Inclusion criteria

  • Non-small cell lung carcinoma in patients with predominantly non-squamous cell carcinoma histology