Selumetinib in combination with 1st line chemotherapy in NSCLC

• Research type

  Research Study

• Full title

  A Phase I/Ib, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung Cancer (NSCLC), SELECT-3

• IRAS ID

  120448

• Contact name

  Emma Dean

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2012-005202-22

• Research summary

  Patients diagnosed with advanced (not curable with surgery) Non-Small Cell Lung Cancer (NSCLC) are routinely treated with two drugs, known as platinum-containing doublet chemotherapy. Selumetinib is an experimental treatment for cancer which has been shown to provide clinical benefit when given in combination with chemotherapy in patients with advanced NSCLC who have had previous chemotherapy. This study will treat newly diagnosed advanced NSCLC patients with the combination of selumetinib and doublet chemotherapy at different doses, and will help to understand the side effects that may occur and the anti-cancer effects of the combination. Chemotherapy agents are known to cause some side effects and the combination with selumetinib may cause additional side effects or the side effects being more intense. Patients will be closely monitored by means of blood tests, physical examination, eye tests, heart tests (ECG and echocardiogram / MUGA) throughout the study, and will have regular scans to look for effects on the tumour. To be eligible for the study, male and female patients must be at least 18 years old with advanced NSCLC, which has not yet been treated. Female patients must not be pregnant or breast-feeding. Male patients and female patients of childbearing potential must use adequate birth control methods. During the study patients will receive chemotherapy intravenously on the 1st and 8th day of a 3-weekly cycle (usually up to 6 cycles), and selumetinib twice daily until the end of the study. Patients will have clinic visits every week in the first cycle, then once per cycle, until they are no longer having clinical benefit from the treatment. The study is expected to last for 18 months with an average patient participation lasting 12 months. Four hospital sites in the UK will participate. It is expected that up to 23 patients will be recruited.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  13/LO/0125

• Date of REC Opinion

  20 Feb 2013

• REC opinion

  Further Information Favourable Opinion