LATIFY

• Research type

  Research Study

• Full title

  A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD- (L)1 Therapy and Platinum-based Chemotherapy: LATIFY

• IRAS ID

  1005783

• Contact name

  Lynne Jordan

• Contact email

  lynne.jordan@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2022-000493-26

• Clinicaltrials.gov Identifier

  NCT05450692

• Research summary

  The study is being done to learn more about the effect of Ceralasertib plus Durvalumab on the inhibition (slowing or prevention) of tumour growth, and also to better understand Non-Small Cell Lung Cancer (NSCLC) and it’s associated health problems.
  Patients may be invited to take part in this study if they have Non-Small Cell Lung Cancer (NSCLC) and meet the eligibility criteria.
  Ceralasertib is an experimental study treatment that works as an inhibitor (to prevent or slow tumour growth) of a specific protein in different cancers. Durvalumab is an inhibitor which has been shown to be effective in some cancer types and is approved for treatment of NSCLC in many countries, including Europe (EU) and the United States (US).
  The study will have two groups. Patients will only take part in one of these groups and will be randomly assigned (like flipping a coin):
  In Group A Participants will receive Ceralasertib and Durvalumab.
  In Group B Participants will receive Docetaxel only.
  During the study, some tests and procedures will be performed on participants, these may include but are not limited to: Collection of demographics (such as age and sex), vital signs (blood pressure, heart rate, breathing rate, and body temperature), tumour samples, blood samples, electrocardiograms (a test that records the heart’s rhythm) and tumour imaging (techniques used to produce detailed images of the inside of the body).
  Participants may continue in the study as long as they tolerate the study treatment, and the study doctor considers that they are benefitting from the treatment.
  About 580 people will take part in this study globally.

• REC name

  Wales REC 3

• REC reference

  22/WA/0249

• Date of REC Opinion

  19 Oct 2022

• REC opinion

  Further Information Favourable Opinion