About this trial
This study will consist of two treatment arms (Groups A and B).
Participants will be randomised in a 1:1 ratio to one of the two treatment groups:
Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.
Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
- Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
- Adequate organ function and marrow reserve
- Minimum life expectancy of 12 weeks.
- Body weight > 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).
Where’s this trial being run?
Beaumont Hospital, Cork University Hospital, Letterkenny University Hospital, Tallaght University Hospital, St Vincents University Hospital, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
Why not Print this page and bring it with you. It will help your doctor and research team advise you.Print this page
For more detailed informationClick Here
LATIFY: A randomised phase 3 study of Ceralasertib + Durvalumab versus Docetaxel in patients with non small cell lung cancer whose disease progressed on or after prior anti PD (L)1 therapy and platinum based chemotherapy.
|Principal Investigator:||Prof Jarushka Naidoo|
|Global Recruitment Target:||580|
|Ireland Recruitment Target:||7|