JMIK: Role of TS expression in NSCLC

• Research type

  Research Study

• Full title

  Protocol H3E-BP-JMIK: An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival seen with Pemetrexed/Cisplatin and the role of Thymidylate Synthase Expression.

• IRAS ID

  6426

• Sponsor organisation

  Eli Lilly and Company Limited

• Eudract number

  2008-006709-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Lung cancer is one of the leading causes of cancer-related deaths in industrialised countries, with non-small cell lung cancer (NSCLC) accounting for the majority of cases. NSCLC covers three main types of lung cancer; squamous cell carcinoma (which develops from the cells which line the airways), adenocarcinoma (which develops from the cells which produce mucus in the lining of the airways) and large cell carcinoma (which gets its name from the large, rounded cells that are seen under the microscope). This study will not include patients with squamous cell carcinoma.Thymidilate Synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous NSCLC. The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment.TS levels will be measured from the tumour sample used to make the original diagnosis of NSCLC. No extra tissue sample would be taken.Approximately 68 patients will be included in this study.Pemetrexed is made by Eli Lilly and Company, and this study is being conducted by them.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/32

• Date of REC Opinion

  5 Mar 2009

• REC opinion

  Favourable Opinion