2024-512583-57-00尚未招募3 期
A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 204
- 试验地点
- 65
- 主要终点
- Progression-free Survival (PFS) per RECIST v1.1
研究概览
简要总结
To evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab, as measured by Progression-free Survival (PFS) per Blinded Independent Central Review and Overall Survival (OS).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post Intervention 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
- •HER2 positive for gastric cancer on a tumor biopsy.
- •PD-L1 combined positive score (CPS) ≥
- •Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.
- •Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.
- •WHO or Eastern Cooperative Oncology Group performance status of 0 or
- •Have measurable target disease assessed by the Investigator based on RECISTv1.
- •Have adequate organ and bone marrow function within 14 days before randomization.
- •LVEF ≥ 55% within 28 days before randomization.
- •Adequate treatment washout period before randomization.
排除标准
- •Lack of physiological integrity of the upper gastrointestinal tract.
- •Any concurrent anti-cancer treatment with the exception of receptor activator ofnuclear factor kappa-B ligand inhibitors.
- •Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
- •Known dihydropyrimidine dehydrogenase enzyme deficiency.
- •Current or prior use of immunosuppressive medication within 14 days before study intervention.
- •Contraindication to pembrolizumab or trastuzumab, contraindications tofluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
- •History of another primary malignancy except for malignancy treated with curativeintent with no known active disease within 3 years before the first dose of studyintervention and of low potential risk for recurrence.
- •Persistent toxicities caused by previous anti-cancer therapy.
- •Has spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
- •Uncontrolled infection including tuberculosis and active hepatitis A infection.
- •Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
- •Chronic/active HBV or HCV infection unless controlled.
- •Recent receipt of live, attenuated vaccine.
- •Clinically significant cardiac or psychological conditions.
- •Active or prior documented autoimmune or inflammatory disorders requiringchronic treatment with steroids or other immunosuppressive treatment.
- •History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or wheresuspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Lung-specific intercurrent clinically significant illnesses.
- •Any active non-infectious skin disease requiring systemic treatment.
- •A pleural effusion, ascites or pericardial effusion that requires drainage, peritonealshunt, or cell-free and concentrated ascites reinfusion therapy (CART).
- •History of any of the following: drug-induced severecutaneous adverse reaction.
结局指标
主要结局
Progression-free Survival (PFS) per RECIST v1.1
Progression-free Survival (PFS) per RECIST v1.1
Overall Survival (OS)
Overall Survival (OS)
次要结局
- PFS based on RECIST v1.1.
- Objective Response Rate (ORR) according to RECIST v1.1.
- Duration of Response (DoR) according to RECIST v1.1.
- Time to second progression or death.
- Progression-free Survival (PFS) at 6 and 12 months (PFS6 and PFS12).
- Overall Survival (OS) at 12 and 24 months (OS12 andOS24).
- Occurrence of AEs, SAEs, AESIs.
- Changes from baseline in laboratory parameters, vitalsigns, electrocardiogram data, and results ofechocardiogram/multiple gated acquisition.
- Serum concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, T-DXd, plasma concentration of 5-FU andcapecitabine.
- Presence of anti-drug antibodies for rilvegostomig and T-DXd.
- Time to increase in enteral feeding assistance and/or eating difficulties.
- The proportion of time on study intervention with highside-effect bother.
- The proportion of participants with stable or improvedphysical function while on treatment.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (65)
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