A Study of Pemetrexed and Gefitinib Versus Gefitinib in Non-Small Cell Lung Cancer (NSCLC)

Phase 2 Completed 195 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the combination of pemetrexed and gefitinib versus gefitinib alone, in terms of progression-free survival. This study is in participants who have stage IV non squamous NSCLC with activating epidermal growth factor mutations and who have not had any previous chemotherapy for stage IV disease.

Timeline

Start: 2012-02
Primary completion: 2015-04
Completion: 2017-11

Outcome

Met primary endpoint

registry 250 mg Gefitinib/500 mg Pemetrexed vs 250 mg Gefitinib; p = 0.009; Hazard Ratio (HR) 0.67 (95% CI 0.48 to 0.93) NCT01469000 ↗

paper PFS was significantly longer with P+G (median, 15.8 months; 95% CI, 12.6 to 18.3 months) than with gefitinib PMID 27507876 ↗

Publications

Cheng Y, Murakami H, Yang PC, He J, Nakagawa K, Kang JH, Kim JH, Wang X, Enatsu S, Puri T, Orlando M, Yang JC. Randomized Phase II Trial of Gefitinib With and Without Pemetrexed as First-Line Therapy in Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations. J Clin Oncol. 2016 Sep 20;34(27):3258-66. doi: 10.1200/JCO.2016.66.9218. Epub 2016 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	Oral
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous