NCT07379476招募中2 期
ATOM2: A Randomized Phase II Trial on Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer After Osimertinib Treatment
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator.
研究概览
简要总结
This is an open-label, multicentre, randomized phase II clinical trial. Patients with stage IV (AJCC 9th edition) non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 L858R mutation, who had less than or equal to 3 active oligoresidual cancer sites amenable to local ablative therapy (LAT) (as determined by physician) after 3-6 months of firstline osimertinib treatment, are eligible. Subjects will be randomized 1:1 to osimertinib with or without LAT.
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
- •18 years of age or older and able to understand and give written informed consent
- •Pathologically proven non-small cell lung cancer
- •Positive for EGFR exon 19 deletion or EGFR exon 21 L858R mutation (either by tissue or plasma testing)
- •Stage IV disease
- •Receive first line osimertinib monotherapy for stage IV disease
- •Undergo a PET-CT scan after 12-24 weeks of initiation of osimertinib treatment, with no evidence of disease progression, and less than or equal to 3 active disease sites (including primary tumour) amenable to local ablative therapy, as determined by investigator
- •At least one brain imaging (CT Brain or MRI Brain with contrast, preferably MRI Brain), either at time of diagnosis or while on osimertinib treatment but before randomization, to document CNS status for stratification. Patients with asymptomatic CNS metastases are eligible. For patients with brain metastases diagnosed at baseline, follow up brain imaging is recommended before randomization.
- •Patients with history of palliative radiotherapy are eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate haematological values: haemoglobin ≥9.0g/dL, absolute neutreophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L
- •Adequate hepatic function: bilirubin ≤1.5 x ULN, AST/ALT ≤2.5 x ULN
- •Adequate renal function: creatinine clearance ≥30ml/min, according to the formula of Cockcroft-Gault equation
- •Willing and able to comply with the requirements and restrictions in this protocol
排除标准
- •Previous or concomitant malignancy within 5 years prior registration with the exception of adequately treated localized non-melanoma skin cancer or cervical cancer in situ.
- •Mixed SCLC and NSCLC histology
- •Positive pregnancy test
- •Contraindication to radiotherapy
- •Any serious underlying medical, psychiatric, psychological, familial condition that in the judgement of the investigator, that may interfere with planned staging, treatment and follow up, affect patient compliance, or place the patient at high risk from treatment related complications
研究组 & 干预措施
Radiotherapy arm
Experimental
- Continue osimertinib as per standard of care (40mg or 80mg daily).
- Undergo radiotherapy to 1-3 disease sites as determined by the investigator.
干预措施: Local ablative therapy (Radiation)
Control arm
Active Comparator
Continue osimertinib as per standard of care (40mg or 80mg daily)
干预措施: Osimertinib alone (Drug)
结局指标
主要结局
18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator.
时间窗: up to 2 years
次要结局
- Overall survival (OS)(2 years)
- Safety and tolerability reflected by number of participants with treatment related adverse events as assessed by CTCAE v5.0, number of participants with SAE(2 years)
- Time to treatment failure (TTF), defined as the time period between osimertinib initiation and cessation or death(2 years)
- Site of tumour progression at disease progression(2 years)
研究者
Molly SC Li
Assistant Professor
Chinese University of Hong Kong
研究点 (1)
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