Trial Information

A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer

To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of
patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated
thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with
corresponding confidence intervals using the exact method. The method of Atkinson and Brown
will be used due to the two-stage sampling; the method of Conover will be used for tumor
response.

To estimate tumor response rates of this treatment regimen and identify the most effective
RT dose level, defined as the level associated with the best response rate. Estimates of
tumor response rates will be presented with corresponding confidence intervals using the
exact method of Conover. Survival will be estimated by the Kaplan-Meier method.