JPRN-jRCT2031220611
招募中
3 期
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2023年2月6日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Hibi Kazushige
- 入组人数
- 55
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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).
排除标准
- •\- 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.
结局指标
主要结局
未指定
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