Study identifier:D533BC00001
ClinicalTrials.gov identifier:NCT05450692
EudraCT identifier:2022-000493-26
CTIS identifier:2023-509429-37-00
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
Advanced or Metastatic Non-Small Cell Lung Cancer
Phase 3
No
Ceralasertib, Durvalumab, Docetaxel
All
594
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group A: Ceralasertib plus durvalumab combination therapy Participants will be administered ceralasertib orally followed by durvalumab administered intravenously. | Drug: Ceralasertib Participants will receive ceralasertib oral tablets. Drug: Durvalumab Participants will receive durvalumab as an intravenous infusion. |
Active Comparator: Group B: Docetaxel monotherapy Participants will be administered docetaxel (standard of care) administered intravenously. | Drug: Docetaxel Participants will received docetaxel as an intravenous infusion. |