PURPOSE: This trial is designed to compare the combination of the investigational oral
cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced
Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy
treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a
member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been
clinically proven to be one of the most effective classes of anticancer therapies. Unlike
the currently marketed platinum-based drugs, satraplatin can be given orally.
RATIONALE: Intravenously administered platinum-based drugs are currently used in
combination with radiation therapy in the treatment of patients with locally advanced NSCLC.
The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral
platinum drug (satraplatin) when given to NSCLC patients throughout the course of their
- Locally advanced or medically inoperable NSCLC (stage II or III)
- ECOG performance status score 0-2
- Adequate bone marrow, liver, and pulmonary functions
- Life expectancy > three months.
- Prior malignancy
- Serious concurrent uncontrolled medical disorder.
- Uncontrolled or significant cardiovascular disease
- History of mastectomy
- Pregnant or breast-feeding patients are not eligible
- Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy