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 - LATIFY

AstraZeneca AB0 个研究点目标入组 580 人2023年1月13日

概览

暂无简介。

注册库

who.int

开始日期

2023年1月13日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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.
•10\. Negative pregnancy test (serum test) for WOCBP.

•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 therapy.
•(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 require maintenance doses of \> 10 mg prednisone or equivalent per day.