2023-505077-32-00招募中3 期
A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig (AZD2936) or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 199
- 试验地点
- 59
- 主要终点
- Assessment of PFS by BICR in TROP2 biomarker positive participants.
研究概览
简要总结
- To demonstrate the superiority of the Dato-DXd in combination with rilvegostomig relative to pembrolizumab by assessment of PFS by BICR in TROP2 biomarker positive participants.
- To demonstrate the superiority of Dato-DXd in combination with rilvegostomig relative to pembrolizumab by assessment of OS in TROP2 biomarker positive participants.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post-intervention follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically or cytologically documented non-squamous NSCLC.
- •Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
- •Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and abscence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
- •Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
- •Known tumour PD-L1 expression status defined as TC ≥ 50%, determined prospectively using the VENTANA PD-L1 (SP263) Assay.
- •At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline.
- •ECOG performance status of 0 or 1
- •Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.
排除标准
- •Prior systemic therapy for advanced/metastatic NSCLC.
- •History of leptomeningeal carcinomatosis
- •Known clinically significant corneal disease
- •Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- •History of active primary immunodeficiency
- •Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- •History of another primary malignancy within 3 years.
- •Active or prior documented autoimmune or inflammatory disorders (with exceptions).
- •Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
- •Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- •History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- •Has significant pulmonary function compromise, as determined by the investigator
- •Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
结局指标
主要结局
Assessment of PFS by BICR in TROP2 biomarker positive participants.
Assessment of PFS by BICR in TROP2 biomarker positive participants.
Assessment of OS in TROP2 biomarker positive participants.
Assessment of OS in TROP2 biomarker positive participants.
次要结局
- Assessment of PFS by BICR in the FAS population.
- Assessment of OS in the FAS population.
- Objective Response Rate (ORR), Duration of Response (DoR)
- Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab
- Pharmacokinetics (PK)
- Immunogenicity
- Second Progression-Free Survival (PFS2)
- Safety and tolerabillity evaluated in terms of AEs
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (59)
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