NL-OMON53518
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 - LATIFY
Astra Zeneca0 个研究点目标入组 19 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Astra Zeneca
- 入组人数
- 19
- 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
- •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, at the time of study enrolment. Participants with unknown status are
- •not allowed onto the study. Note: A computed tomography or magnetic resonance
- •imaging scan of the brain at baseline is required for all subjects.
- •3 Where available, a tissue sample obtained after progression on prior
- •anti\-PD\-(L)1 therapy and \<\= 3 months prior to randomisation should be provided.
- •Where no such sample is available a tumour sample taken \<\= 24 months prior to
- •screening is acceptable. Samples should be of sufficient quality to enable
排除标准
- •1 Participant with mixed SCLC and NSCLC histology.
- •2 As judged by the investigator, any evidence of diseases (such as severe or
- •uncontrolled systemic diseases, including uncontrolled hypertension, active
- •bleeding diseases, active infection, active interstitial lung
- •disease/pneumonitis, serious chronic gastrointestinal conditions associated
- •with diarrhoea, psychiatric illness/social situations), history of allogenic
- •organ transplant, which, in the investigator\*s opinion, makes it undesirable
- •for the participant to participate in the study or that would jeopardise
- •compliance with the protocol.
- •3 Refractory nausea and vomiting, chronic gastrointestinal disease, inability
结局指标
主要结局
未指定
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