drugset / Trial / NCT01017874
A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
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
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 |