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

Hibi Kazushige0 个研究点目标入组 55 人开始时间: 2023年2月6日最近更新: 2023年10月17日

试验速览

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•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).

•- Participant with mixed SCLC and NSCLC histology.
•- History of another primary malignancy except for malignancy treated with curative intent with no known active disease 5 yearsor more before the first dose of study intervention.
•- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
•- Active or prior documented autoimmune or inflammatory disorders.
•- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
•- Participants:
•1. Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
•2. All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
•3. Must not have experienced a Grade 3 or more immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
•4. 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.
•- Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
•- Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

发起方

Hibi Kazushige