This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS). (TROPION-Lung15)

Astrazeneca K.K0 个研究点目标入组 77 人开始时间: 2024年10月17日最近更新: 2025年5月13日

试验速览

阶段: 不适用
状态: 招募中
发起方: Astrazeneca K.K
入组人数: 77
主要终点: PFS

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Histologically or cytologically confirmed non-squamous NSCLC.
•Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M).
•Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
•Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
•At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
•World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Adequate bone marrow reserve and organ function within 7 days before randomization.

排除标准

•Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the Paliiative. Platinum-based chemotherapy in Curative setting within 12 months prior to randomization.
•History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
•Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
•Has significant third-space fluid retention (example [eg.], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
•History of ILD/pneumonitis including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
•Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
•Unstable spinal cord compression and/or unstable brain metastases.
•Participants with symptomatic brain metastases (including leptomeningeal involvement).
•Clinically significant corneal disease.
•Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections.
•Has known human immunodeficiency virus (HIV) infection that is not well controlled.

结局指标

主要结局

PFS

defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression

次要结局

未报告次要终点

研究者

发起方

Astrazeneca K.K

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