LDK378 vs Chemo in newly diagnosed untreated ALK+ NSCLC patients

• Research type

  Research Study

• Full title

  A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK positive), stage IIIB or IV, non-squamous non-small cell lung cancer

• IRAS ID

  133706

• Contact name

  Raffaele Califano

• Contact email

  Raffaele.Califano@christie.nhs.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2013-000319-26

• Duration of Study in the UK

  4 years, 1 months, 1 days

• Research summary

  The goal of this study is to find out if LDK378, a new investigational drug has any effect in patients with non small cell lung cancer (NSCLC) who have the abnormal ALK gene (i.e ALK postive). We know from research that LDK378 can slow down the growth of cancer cells by blocking the ALK protein which is responsible for sending growth signals to cancer cells. Recent results from an ongoing Phase I study investigating the antitumor activity of LDK378 in 88 patients with ALK+ showed marked responses in a majority of patients with ALK+ NSCLC. A response rate of 62% was observed in the patients who had not been previously treated with any ALK inhibitor.

  The aims of this trial are as follows;
  • To further evaluate the compound in this patient population
  • Show that LDK378 is more effective than standard 1st line chemotherapy (pemetrexed in combination with cisplatin or carboplatin)
  • Find out more about LDK378 and what happens to it in the body
  • Learn more about the side effects of LDK378

  This trial is sponsored by the pharmaceutical company named Novartis and about 348 patients will join this study from different countries. Patients will be randomly assigned to LDK378 or standard chemotherapy. Patients will be carefully monitored during the study and will be asked to visit the study hospital every 2 weeks for the first month, then every 4 weeks. Because the safety and efficacy profile of LDK378 has not yet been established, access to this investigational compound is available only through carefully controlled and monitored clinical trials such as this. Because of uncertainty of clinical trials, there is no guarantee that LDK378 will ever be commercially available anywhere in the world.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0698

• Date of REC Opinion

  20 Nov 2013

• REC opinion

  Further Information Favourable Opinion