A Phase 2, Single-Arm, Multicenter Trial of Zanzalintinib in Combination With Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Exelixis
- 入组人数
- 60
- 主要终点
- Progression-Free Survival (PFS) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator
研究概览
简要总结
The primary purpose of the study is to evaluate the effectiveness of zanzalintinib in combination with pembrolizumab as first-line maintenance therapy in participants with metastatic squamous NSCLC.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 6 months.
- Stage IV squamous NSCLC as defined by American Joint Committee on Cancer (AJCC) 9th Edition.
- Measurable disease according to RECIST v1.1 as determined by the investigator and documented prior to starting induction therapy.
- Programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) < 50% as assessed per local testing. To minimize assay variability, local laboratory must ascertain PD-L1 status using the PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx assay.
- Key
排除标准
- Nonsquamous histology NSCLC.
- Tumor invasion, encasement of organs, or major blood vessels, if poses a significant increased risk of bleeding.
- Targetable genomic aberrations for which approved targeted therapy is available.
- The participant has uncontrolled, significant intercurrent or recent illness.
- Active autoimmune disease or a history of autoimmune disease within 2 years prior to the first dose of induction therapy requiring systemic immunosuppressive therapy.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanzalintinib + Pembrolizumab
Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.
Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.
干预措施: Carboplatin (Drug)
Zanzalintinib + Pembrolizumab
Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.
Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.
干预措施: Pembrolizumab (Drug)
Zanzalintinib + Pembrolizumab
Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.
Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.
干预措施: Paclitaxel (Drug)
Zanzalintinib + Pembrolizumab
Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.
Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.
干预措施: Nab-paclitaxel (Drug)
Zanzalintinib + Pembrolizumab
Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.
Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.
干预措施: Zanzalintinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator
时间窗: 6 months
次要结局
- Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator(Up to 30 months)
- Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator(Up to 30 months)
- PFS per RECIST v1.1 as assessed by Investigator(Up to 30 months)
- Overall Survival (OS)(Up to 30 months)
- Number of Participants With Adverse Events (AEs)(Up to 30 months)
研究者
标识符
- NCT 编号
- NCT07845786
- 其他研究编号
- XL092-202
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否