NCT07680790尚未招募3 期
A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 850
- 试验地点
- 211
- 主要终点
- Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
研究概览
简要总结
The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
- •Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)
- •Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator
- •Participants must have ECOG Performance Status 0-1
排除标准
- •Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression
- •Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis
- •Participants must not have clinically significant cardiac disease
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Arm B
Active Comparator
干预措施: Carboplatin (Drug)
Arm B
Active Comparator
干预措施: Cisplatin (Drug)
Arm B
Active Comparator
干预措施: Osimertinib (Drug)
Arm A
Experimental
干预措施: Osimertinib (Drug)
Arm A
Experimental
干预措施: Iza-bren (Drug)
Arm B
Active Comparator
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
时间窗: Up to approximately 3 years
次要结局
- Overall Survival (OS)(Up to approximately 5 years)
- PFS assessed by the investigator as per RECIST v1.1(Up to approximately 3 years)
- Second Progression-Free Survival (PFS2) as assessed by the Investigator(Up to approximately 5 years)
- Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1(Up to approximately 3 years)
- Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1(Up to approximately 3 years)
- Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1(Up to approximately 3 years)
- Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1(Up to approximately 3 years)
- Duration of Response (DOR) assessed by the BICR as per RECIST v1.1(Up to approximately 3 years)
- Duration of Response (DOR) assessed by the investigator as per RECIST v1.1(Up to approximately 3 years)
研究者
研究点 (211)
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