Conditions: Cancer Carcinoma, Non-Small Cell Lung
Keywords: NSCLC
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.

* If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
* If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.
* If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.

Detailed description:
In addition to the key secondary outcome parameters several potential biomarkers were evaluated as exploratory parameters.

Issues on safety are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section:

* gastrointestinal (GI)
* not otherwise specified (NOS)
* central nervous system (CNS)
* National Cancer Institute Common Terminology Criteria (NCI-CTC)
* Medical Dictionary for Regulatory Activities (MedDRA)
* System Organ Class (SOC)
* interim analysis (IA)

Arms:
arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: BAY43-9006 400 mg bid X 28 day cycles \[Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.

Protocol document: