Study Investigating Addition of Iressa to Conventional Treatment in Lung Cancer Patients

October 1, 2001

The Southwest Oncology Group (SWOG) is initiating a phase III trial (S0023) that will compare conventional chemoradiotherapy with consolidation docetaxel (Taxotere) followed by maintenance therapy with the investigational agent

The Southwest Oncology Group (SWOG) isinitiating a phase III trial (S0023) that will compare conventionalchemoradiotherapy with consolidation docetaxel (Taxotere) followed bymaintenance therapy with the investigational agent Iressa (ZD1839) vs placebofor the treatment of inoperable, locally advanced non-small-cell lung cancer.

Patient enrollment is under way, and approximately 840 menand women are being recruited. The National Cancer Institute is funding thetrial.

"Recent studies have shown that Iressa shrinks tumors inpatients with advanced non-small-cell lung cancer and is also associated withmild side effects," said study coordinator Karen Kelly, MD, associateprofessor of medicine at the University of Colorado Health Sciences Center inDenver.

Study Goals and Protocol

Standard treatment for this patient population ischemoradiotherapy, which in the past has produced a median survival rate ofapproximately 13 to 17 months and an approximate 3-year survival of 20%."While, in the past, standard chemotherapy combinations with radiotherapyresulted in a small benefit on survival, there is a need for the development ofnovel cancer agents like Iressa that may improve therapeutic outcome," saidDr. Kelly.

The primary objectives of the trial are to determine whethertreatment with ZD1839 improves overall and progression-free survival in patientswith inoperable non-small-cell lung cancer who have been treated withchemotherapy and radiation and to assess the safety of its long-term use. Anadditional goal is to establish a lung cancer specimen bank that will storetissue from lung cancer patients for use in current and future scientificresearch studies.

Participants in the trial will be randomized to receive oneof two treatment regimens: cisplatin (Platinol), etoposide, and radiationfollowed by docetaxel and ZD1839; or cisplatin, etoposide, and radiationfollowed by docetaxel and placebo. Treatment will continue in each arm for amaximum of 5 years.