Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone

Summary

This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer.

Timeline

Start

2011-08

Primary completion

2016-07

Completion

2016-07

Outcome

Missed primary endpoint

registry Control Gefitinib vs Experimental: Gefitinib in Combination With Olaparib; p = 0.124; Hazard Ratio (HR) 1.38 (95% CI 1.00 to 1.92); Log Rank NCT01513174 ↗

paper The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone. PMID 33070053 ↗

Publications

• Results Garcia-Campelo R, Arrieta O, Massuti B, Rodriguez-Abreu D, Granados ALO, Majem M, Vicente D, Lianes P, Bosch-Barrera J, Insa A, Domine M, Reguart N, Guirado M, Sala MA, Vazquez-Estevez S, Caro RB, Drozdowskyj A, Verdu A, Karachaliou N, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group (SLCG). Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL). Lung Cancer. 2020 Dec;150:62-69. doi: 10.1016/j.lungcan.2020.09.018. Epub 2020 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	—
Subject	Olaparib	Small molecule	200 mg	—

Indications