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D533BC00001 AstraZeneca AB / “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 Whos

NCT05450692

AstraZeneca AB / “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”

Associated Conditions

Lung Cancer

Principal Investigator

Sponsor

AstraZeneca AB

We are doing this study to learn more about the effect of Ceralasertib plus Durvalumab on the inhibition of tumor growth, and also to better understand the studied disease and associated
health problems. Ceralasertib is an experimental study treatment that works as a selective inhibitor of a specific protein (ATR kinase) in different solid and hematologic cancers (cancer that begins in blood-forming tissue, such as bone marrow or in the cells of the immune system). Durvalumab is a PD-(L)1 inhibitor which has been shown to be effective in some cancer types and is approved for treatment of NSCLC as monotherapy or part of treatment in many countries, including Europe (EU) and the United States (US). Docetaxel is one standard of care chemotherapy agent which will be used to compare to the combination of ceralasertib and durvalumab. Some parts of this study are experimental which means it is not approved by any health authority, such as the U.S. Food and Drug Administration (FDA), except for use in research studies like this. The experimental part of the study is the combination of Ceralasertib plus Durvalumab.