A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 15
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.
详细描述
Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion), post-treatment follow-up period, and long-term extension period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)
- •Part 1: NSCLC with a known actionable genetic mutation (for example, epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], c-ros oncogene 1 [ROS1], v-raf murine sarcoma viral oncogene homolog B1 [BRAF]) must have received all approved targeted therapies and have progressed
- •Part 2: No targetable mutations (for example, EGFR [epidermal growth factor receptor], ALK [anaplastic lymphoma kinase], ROS1[c-ros oncogene 1], and BRAF [B-Raf proto-oncogene, serine/threonine kinase])
- •Part 1 and Cohort A of part 2: Must have been treated with (a) anti-programmed death protein 1 (anti-PD-1) or programmed cell death ligand 1 (PD-L1) therapy and (b) platinum-based chemotherapy
- •For Cohort B of Part 2: Previously treated with anti-PD-1/PD-L1 therapy for metastatic disease as the prior line of therapy
- •For Cohort C of Part 2: Treatment naïve
- •Adequate organ function
排除标准
- •Active central nervous system (CNS) disease involvement
- •Active autoimmune disease
- •Active infection
- •History of solid organ or hematologic stem cell transplantation
研究组 & 干预措施
Part 1: JNJ-86974680+Cetrelimab
Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab.
干预措施: Cetrelimab (Drug)
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.
干预措施: JNJ-86974680 (Drug)
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.
干预措施: Radiation Therapy (Radiation)
Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT)
Part 2 will consist of 3 cohorts (A, B and C) and participants will receive treatment with the selected dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.
干预措施: Cetrelimab (Drug)
Part 1: JNJ-86974680+Cetrelimab
Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab.
干预措施: JNJ-86974680 (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: Up to 2 years 5 months
The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to 2 years 5 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
次要结局
- Part 2: Complete Response Rate (CRR)(Up to 2 years 5 months)
- Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680(Up to 2 years 5 months)
- Part 2: Overall Response Rate (ORR)(Up to 2 years 5 months)
- Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680(Up to 2 years 5 months)
- Part 2: Duration of Response (DOR)(Up to 2 years 5 months)
- Part 2: Disease Control Rate (DCR)(Up to 2 years 5 months)