LY2875358 plus Erlotinib and LY2875358 Monotherapy in NSCLC (JTBC)

  • Research type

    Research Study

  • Full title

    A randomized, Open-Label, Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients with Acquired Resistance to Erlotinib

  • IRAS ID

    129444

  • Contact name

    Denis C Talbot

  • Contact email

    rachel.shaw@medonc.ox.ac.uk

  • Sponsor organisation

    Eli Lilly and Company

  • Eudract number

    2012-005477-31

  • ISRCTN Number

    n/a

  • Research summary

    The use of Erlotinib to treat patients with advanced Non-Small Cell Lung Cancer (NSCLC) patients with tumours that have epidermal growth factor receptor mutations (EGFRmt)(EGF is a growth factor that stimulates cell growth and having mutations in this growth factor can cause some types of cancer to develop, icluding NSCLC) has seen significant progression free survival (PFS)and overall response rate (ORR). However, the majority of patients whose initial disease response to Erlotinib is positive develop a resistance to this treatment and their disease begins to progress once more.

    LY2875358 is a new drug being developed to try and combat the development of tumour/disease resistance to treatment.

    To be eligible to participate in this study patients must be over 18 years old and have a diagnosis of Stage IV Non-Small Cell Lung Cancer (NSCLC). It is estimated that each patient will be in the study for around 6 months and that the whole study will last for approximately 15 months.

    Study assessments will include: Physical examinations, Questionnaire completion, Blood and urine tests and radiological scans (CT, MRI or PET scans might be used).

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    13/SC/0348

  • Date of REC Opinion

    23 Aug 2013

  • REC opinion

    Further Information Favourable Opinion