drugset / Trial / NCT01544179

A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone

NCT01544179

Phase 3 Completed 265 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

Timeline

Start
2012-03-15
Primary completion
2014-05-05
Completion
2019-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg Oral
Background Cisplatin Other / unclassified 75 mg/m2
Background Pemetrexed Small molecule 500 mg/m2