JACW - LY2181308 with Docetaxel in non-small cell lung cancer

• Research type

  Research Study

• Full title

  A Randomized Phase 2 Study of LY2181308 in Combination with Docetaxel versus Docetaxel in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer who Were Previously Treated with First Line Chemotherapy

• IRAS ID

  46476

• Contact name

  Denis Talbot

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2009-017591-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Study H8Z-MC-JACW (Study JACW) is an international, multicenter, randomised, open-label, Phase 2 study of LY2181308 in combination with docetaxel compared to docetaxel in patients with locally advanced metastatic non-small cell lung cancer (NSCLC) who were previously treated with first line chemotherapy. The study has 2 arms, Arm A and Arm B. Approximately 150 patients will be randomised to Arm A or Arm B using a 2:1 ratio. ??Arm A: 750 mg LY2181308 weekly in combination with 75 mg/m2 docetaxel given on Day 1 of each 21 day (3 week) cycle ??Arm B: 75 mg/m2 docetaxel given on Day 1 of each 21 day (3 week) cycle.The planned length of treatment is 6 cycles but participants may have the option to continue for further cycles at the discretion of the investigator. The study will look at the change in tumour size at the start of the study compared to a measurement taken at the end of cycle 2.Lung cancer is one of the most common cancers in the world, with an estimated 1.5 million new cases and just over 1.4 million projected deaths each year. Lung cancer was also the largest cause of cancer death in the European Union in 2004, accounting for 20% of all deaths. The majority of lung cancer cases (approximately 85%) are NSCLC. Survivin is a protein in the body which plays an important part in stopping tumour cancer cells dying. LY2181308 (the study drug) specifically stops survivin and so restores normal cell death in tumours. Chemotherapy, such as docetaxel, causes cell death and is expected to be more effective when combined with LY2181308. Docetaxel is approved for the treatment of patients where the disease has spread after failure of certain types of previous chemotherapy and all patients will be receiving this medication.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/37

• Date of REC Opinion

  19 Jul 2010

• REC opinion

  Further Information Favourable Opinion