A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung CancerWithout Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD- (L)1 Therapy and Platinum-based Chemotherapy: LATIFY - LATIFY

ASTRAZENECA AB0 sites580 target enrollmentJune 28, 2022

Overview

No summary available.

Registry

who.int

Start Date

June 28, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Participant must be \>\= 18 years at the time of screening.
•2\. Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
•3\. Documented EGFR and ALK wild\-type status as determined at a local laboratory.
•4\. Documented radiological PD whilst on or after receiving the most recent treatment regimen.
•5\. 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.
•6\. ECOG/WHO performance status of 0 or 1\.
•7\. Adequate organ function and marrow reserve
•8\. Minimum life expectancy of 12 weeks.
•9\. Body weight \> 30 kg and no cancer\-associated cachexia.

•1\. Participant with mixed SCLC and NSCLC histology.
•2\. History of another primary malignancy except for malignancy treated with curative intent with no known active disease \>\= 5 years before the first dose of study intervention.
•3\. Persistent toxicities (CTCAE Grade \> 2\) caused by previous anticancer therapy.
•4\. Active or prior documented autoimmune or inflammatory disorders.
•5\. Participants who have received more than one line of prior anti\-PD\- (L)1, either alone or in any combination.
•6\. Participants:
•(a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti\-PD(L)1 therapy.
•(b) All AEs while receiving prior anti\-PD(L)1 therapy must have completely resolved.
•(c) Must not have experienced a Grade \>\= 3 imAE or an immune\-related neurologic or ocular AE of any grade while receiving prior anti\-PD(L)1
•(d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re\-challenged, and not currently