A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 18
- 主要终点
- Median progression-free survival
研究概览
简要总结
The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.
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
- •Be greater than 18 years of age on day of signing informed consent.
- •Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-
- •o Patients with recurrent metastatic NSCLC following prior durvalumab for stage III disease are eligible provided this is their first immunotherapy course for metastatic disease (i.e., the planned anti-PD-(L)1-based regimen represents first-line systemic therapy in the metastatic setting).
- •Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases
- •Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles
- •o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or anti-PD-L1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed.
- •Have a performance status of 0-2 on the ECOG Performance Scale.
- •Liver function tests:
- •Total Bilirubin ≤ 1.5 x ULN
- •AST/ ALT ≤ 5 x ULN
- •Eligible for L- SABR to all liver metastases as determined by the treating radiation oncologist
- •Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 count >200 cells/microliter within 28 days prior to registration
排除标准
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
- •Patients with prior external beam radiation therapy to the liver.
- •Patients with known active Hepatitis B or Hepatitis C.
- •Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.
- •Patients who are pregnant or breastfeeding
- •Men or women not using effective contraception.
研究组 & 干预措施
Control Arm
Participants randomized to the control arm will be treated according to the standard of care.
干预措施: Anti-PD-(L)1 based immunotherapy (Biological)
L-SABR Arm
Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.
干预措施: L-SABR (Radiation)
L-SABR Arm
Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.
干预措施: Anti-PD-(L)1 based immunotherapy (Biological)
Control Arm
Participants randomized to the control arm will be treated according to the standard of care.
干预措施: Platinum based chemotherapy (Drug)
L-SABR Arm
Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.
干预措施: Platinum based chemotherapy (Drug)
结局指标
主要结局
Median progression-free survival
时间窗: up to 4 years
Primary outcomes is to determine if L-SABR, when added to first line standard of care anti-PD-(L)1 based immunotherapy +/- chemotherapy, can improve median progression-free survival (PFS) in patients with metastatic NSCLC involving the liver.
次要结局
未报告次要终点