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

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

Outcome

Missed primary endpoint

registry analysis (unspecified test); Gefitinib vs Placebo; p = 0.273; Hazard Ratio (HR) 0.86 (95% CI 0.65 to 1.13); Cox Proportional Hazards NCT01544179 ↗

paper Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival PMID 26159065 ↗

Publications

• Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ, Wang J, Yang JC, Lu Y, Atagi S, Ponce S, Lee DH, Liu Y, Yoh K, Zhou JY, Shi X, Webster A, Jiang H, Mok TS. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. doi: 10.1016/S1470-2045(15)00121-7. Epub 2015 Jul 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	Oral
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Pemetrexed	Small molecule	500 mg/m2	—

Indications