MEERKAT study Version 1

• Research type

  Research Study

• Full title

  Phase I Trial of the MEK inhibitor AZD6244 in Combination with Thoracic Radiotherapy in Non-Small Cell Lung Cancer

• IRAS ID

  13766

• Contact name

  Corinne Faivre-Finn

• Sponsor organisation

  The Christie NHS Foundation Trust

• Eudract number

  2009-013922-18

• ISRCTN Number

  2009-013922-18

• Research summary

  Two thirds of non small cell lung cancer patients present with locally advanced tumours (stage III) or with disease which has spread (stage IV) and radiotherapy (RT) plays a major role in their treatment. Treatment (RT and chemotherapy) can be given to cure selected patients with stage III disease. Patients with stage III tumours associated witflud around the lungs, and patients who present with Stage IV disease are treated palliatively with no prospect of cure. RT is offered to patients with advanced NSCLC, aiming to improve symptoms, achieve tumour control and optimise quality of life.It is believed that a plateau has been reached for the combination of chemotherapy with RT in stage III and IV lung cancer and there is a strong rationale for combining molecular targeted drugs with RT. Study drug AZD6244 is a molecular targeted drug (which selectively blocks cell signalling of MEK) that has been tested in early phase clinical trials either alone or combined with chemotherapy in a variety of cancers including lung cancer. Preclinical studies have shown that AZD6244 enhances the effect of radiation and support the combination of AZD6244 plus RT. This is the first study to test AZD6244 with radiotherapy.The study will determine the safety profile of AZD6244 with thoracic RT and the recommended dose for phase II trials (RP2D). Groups of patients will be given increasing or decreasing doses of AZD6244 with RT until the largest tolerated dose is found. Between 21 and 33 patients will be recruited. Patients will also have tissue/blood samples collected to examine genes and proteins (biomarkers) and in a subgroup of patients, FLT-PET imaging will be performed to obtain information that may predict for treatment response, resistance or toxicity.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/73

• Date of REC Opinion

  31 Dec 2009

• REC opinion

  Further Information Favourable Opinion