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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data
研究概览
简要总结
Phase 2 : To determine the RP3D for iza-bren to advance to Stage 2 (Phase 3) of the study. Phase 3: To compare the progression-free survival of iza-bren at RP3D vs platinum-based chemotherapy in participants with advanced EGFRmt NSCLC cancer and disease progression after any 3rd generation TKIs
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
- 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.
结局指标
主要结局
Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data
Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data
Phase 3: progression-free survival by RECIST v1.1 per Blinded Independent Central Review.
Phase 3: progression-free survival by RECIST v1.1 per Blinded Independent Central Review.
次要结局
- Phase 2: Overall Survival by RECIST v1.1 per Blinded Independent Central Review
- Phase 2: Progression-Free Survival rates by RECIST v1.1 per Blinded Independent Central Review
- Phase 3: overall survival (OS).
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company