Status: Closed
Activation Date: 2002SEP13
Closing Date: 2005APR22
Phase: III
Description: A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer
Eligibility: Patients who have histologic evidence of stage IB, II or IIIA primary non-small cell lung cancer that has been completely resected.
Objective: To compare whether adjuvant treatment with ZD1839 (IRESSA) is superiour to placebo in patients with completely resected stage IB, II and IIIA non-small cell lung cancer in terms of : overall survival and disease-free survival. To confirm the prognostic significance and to assess the predictive ability of EGFR expression, phosphorylation and mutations and the likelihood of "response" to ZD1839 (IRESSA) in terms of overall survival. A comprehensive tumour bank will be established and linked to the clinical database for the further study of molecular markers in non-small cell lung cancer. The toxicity related to ZD1839 (IRESSA) will be further evaluated.
Participation: Open to member centres
Lay Description: The purpose of this study is to find out whether it is better to receive the drug ZD1839 (IRESSA) or better to receive no further treatment after surgery for non-small cell lung cancer. To do this, half of the patients in this study will get ZD1839 (IRESSA) and the other half will receive a placebo (a tablet that does not do anything).
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR19 | 503 | 376 | 414 | 425 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| LUNG | BR19 | 503 | 9 | 342 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| LUNG | BR19 | 503 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |