Efficacy & safety of gefitinib in Caucasians with EGFR positive NSCLC

• Research type

  Research Study

• Full title

  An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250mg (IRESSA) as First Line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

• IRAS ID

  48280

• Contact name

  David Ferry

• Sponsor organisation

  AstraZeneca

• Eudract number

  2010-018614-70

• ISRCTN Number

  n/a

• Research summary

  AstraZeneca is conducting a research study with a licensed anti-cancer agent called gefitinib (IRESSA TM) in patients with advanced or metastatic non-small cell cancer (NSCLC). In clinical trials gefitinib has been shown to be more effective than chemotherapy in delaying the progression of the cancer in patients who have a specific alteration in their DNA (a mutation) in their tumour cells. The data in Caucasian patients (of European, North African or Middle Eastern origin) is limited so this trial is designed to provide additional supportive data in this population. This study will provide data 1) On the safety and efficacy of gefitinib in adult Caucasian patients whose tumour cells carry the ??EGFR activating mutation?.2) On the link between clinical characteristics (including ethnic origin) and whether patients have this mutation, and 3) On whether the presence of the mutation can be reliably determined from non-tumour samples (e.g. from a blood sample). At the screening visits, all patients will have a sample of their tumour tested for study eligibility. Eligible patients will receive the licensed dose of gefitinib until their disease progresses (worsens). Patients will attend the clinic for safety assessments every 3 weeks for the first 3 months of the study, then every 6 weeks. They will have a CT or MRI scan every 6 weeks until disease progression to monitor the response of their cancer to treatment. Following disease progression, patients will be followed up every 8 weeks for collection of information on adverse events & anti-cancer treatment. The study will end 6 months after the last patient has been recruited. Patients who have not progressed at the end of the study and who, in the opinion of their consultant, continue to derive benefit from the treatment may continue to receive gefitinib outside this clinical study.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/41

• Date of REC Opinion

  25 Jun 2010

• REC opinion

  Favourable Opinion