A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer

Summary

The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).

Timeline

Start

2009-11

Primary completion

2013-04

Completion

2014-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Pemetrexed + Cisplatin + Gefitinib vs Gefitinib; p = 0.217; Hazard Ratio (HR) 0.85 (95% CI 0.63 to 1.13); Wilcoxon (Mann-Whitney) NCT01017874 ↗

paper PFS was not significantly different between treatment arms (p=0.217). PMID 24953333 ↗

Publications

• Yang JC, Srimuninnimit V, Ahn MJ, Lin CC, Kim SW, Tsai CM, Mok T, Orlando M, Puri T, Wang X, Park K. First-Line Pemetrexed plus Cisplatin followed by Gefitinib Maintenance Therapy versus Gefitinib Monotherapy in East Asian Never-Smoker Patients with Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer: Final Overall Survival Results from a Randomized Phase 3 Study. J Thorac Oncol. 2016 Mar;11(3):370-9. doi: 10.1016/j.jtho.2015.11.008. Epub 2015 Dec 25.
• Kang JH, Ahn MJ, Kim DW, Cho EK, Kim JH, Shin SW, Wang X, Kim JS, Orlando M, Park K. Tolerability and Outcomes of First-Line Pemetrexed-Cisplatin Followed by Gefitinib Maintenance Therapy Versus Gefitinib Monotherapy in Korean Patients with Advanced Nonsquamous Non-small Cell Lung Cancer: A Post Hoc Descriptive Subgroup Analysis of a Randomized, Phase 3 Trial. Cancer Res Treat. 2016 Apr;48(2):458-64. doi: 10.4143/crt.2015.135. Epub 2015 Oct 14.
• Yang JC, Kang JH, Mok T, Ahn MJ, Srimuninnimit V, Lin CC, Kim DW, Tsai CM, Barraclough H, Altug S, Orlando M, Park K. First-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in East Asian patients with locally advanced or metastatic non-squamous non-small cell lung cancer: a randomised, phase 3 trial. Eur J Cancer. 2014 Sep;50(13):2219-30. doi: 10.1016/j.ejca.2014.05.011. Epub 2014 Jun 18.

Drugs

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

Indications