drugset / Trial / NCT00090675

Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

NCT00090675

Phase 3 Withdrawn AstraZeneca
RandomizedDouble-blindTreatment

Summary

In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.

Timeline

Start
2006-01
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule