A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy and in Combination With Izalontamab Brengitecan in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss After Progression on Prior Therapies

Bristol-Myers Squibb130 个研究点分布在 9 个国家目标入组 182 人开始时间: 2025年9月9日最近更新: 2026年9月18日

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 182
试验地点: 130
主要终点: Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy or in combination with Izalontamab Brengitecan in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion or MTAP loss after progression on prior therapies.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
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

•Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
•Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
•At least 1 measurable lesion as per RECIST v1.
•Documented radiographic disease progression on or after the most recent line of treatment.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
•Capability to swallow tablets intact (without chewing or crushing).
•For combination arms
•Participants must have documented evidence of EGFR status.
•Participants with EGFR mutant or wild type NSCLC are allowed.

排除标准

•Active brain metastases or carcinomatous meningitis.
•History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
•Prior treatment with a PRMT5 or MAT2A inhibitor.
•Known severe hypersensitivity to study treatment and/or any of its excipients.
•For combination arms
•a. Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab.
•Other protocol-defined inclusion/exclusion criteria apply.

研究组 & 干预措施

Arm B: BMS-986504 Dose 2

Experimental

干预措施: BMS-986504 (Drug)

Arm A: BMS-986504 Dose 1

Experimental

干预措施: BMS-986504 (Drug)

Arm C: BMS-986504 Dose 1 + Izalontamab Brengitecan

Experimental

干预措施: BMS-986504 (Drug)

Arm C: BMS-986504 Dose 1 + Izalontamab Brengitecan

Experimental

干预措施: Izalontamab Brengitecan (Drug)

Arm D: BMS-986504 Dose 2 + Izalontamab Brengitecan

Experimental

干预措施: BMS-986504 (Drug)

Arm D: BMS-986504 Dose 2 + Izalontamab Brengitecan

Experimental

干预措施: Izalontamab Brengitecan (Drug)

结局指标

主要结局

Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

时间窗: Up to 3 years after the last participant's last dose of study treatment

OR is defined as confirmed complete response (CR) or partial response (PR)

Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria