NCT07100080招募中2 期
IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 185
- 主要终点
- Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
研究概览
简要总结
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
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
- •Non-squamous NSCLC, not amenable to treatment in curative intent.
- •Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
- •Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
- •Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).
排除标准
- •Inadequate organ function and/or bone marrow reserve.
- •Leptomeningeal metastases or spinal cord compression.
- •Poorly controlled systemic medical conditions.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Arm B
Experimental
干预措施: Iza-bren (Drug)
Arm D
Experimental
干预措施: Iza-bren (Drug)
Arm A
Experimental
干预措施: Iza-bren (Drug)
Arm C
Active Comparator
干预措施: Cisplatin (Drug)
Arm E
Active Comparator
干预措施: Cisplatin (Drug)
Arm C
Active Comparator
干预措施: Carboplatin (Drug)
Arm C
Active Comparator
干预措施: Pemetrexed (Drug)
Arm E
Active Comparator
干预措施: Pemetrexed (Drug)
Arm E
Active Comparator
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
时间窗: Up to 3 years
Phase 3
Recommended Phase 3 Dose (RP3D) of BMS-986507
时间窗: Approximately 3 months after the first dose
Phase 2
Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
时间窗: Up to 3 years
Phase 3
次要结局
- Objective Response (OR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- PFS Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Overall Survival (OS)(Up to 5 years)
- PFS Assessed by RECIST v1.1 per investigator assessment(Up to 3 years)
- OR Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Duration of Response (DOR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- PFS Assessed by RECIST v1.1 per investigator assessment(Up to 3 years)
- OR Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Duration of Response (DOR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Time To Response (TTR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Objective Response (OR) Assessed by RECIST v1.1 per BICR(Up to 3 years)
- PFS Assessed by RECIST v1.1 per BICR(Up to 3 years)
- Overall Survival (OS)(Up to 5 years)
研究者
研究点 (185)
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