ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics
概览
- 阶段
- 2 期
- 干预措施
- stereotactic radiosurgery (SRS)
- 疾病 / 适应症
- Non Small Cell Lung Cancer Metastatic
- 发起方
- Memorial Sloan Kettering Cancer Center
- 入组人数
- 56
- 试验地点
- 16
- 主要终点
- intracranial progression-free survival (iPFS)
- 状态
- 招募中
- 最后更新
- 19天前
概览
简要总结
The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.
详细描述
Patients in both arms of this study will receive standard of care (SOC) systemic therapy which includes a backbone of an FDA-approved CNS-active TKI targeting mutant EGFR, specifically osimertinib.
研究者
入排标准
入选标准
- •Participant Inclusion Criteria: Screening
- •Age ≥ 18 years
- •Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution
- •At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement)
- •Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start)
- •Participant
排除标准
- •Unable to undergo contrast-enhanced MRI brain
- •Prior brain-directed radiotherapy
- •Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated.
- •Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS
- •Active hematologic malignancy or a second solid tumor histology with known CNS tropism
- •Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a patient with removal of a 3cm symptomatic brain metastasis, but has an additional visible lesion remaining post-operatively, remains eligible for the study).
- •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- •Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 3 months after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)
- •Participant Inclusion Criteria: Randomization
- •\- Presence of detectable and non-progressing BM lesions on imaging consistent with viable residual disease
研究组 & 干预措施
osimertinib and stereotactic radiosurgery (SRS)
干预措施: stereotactic radiosurgery (SRS)
osimertinib and stereotactic radiosurgery (SRS)
干预措施: osimertinib
osimertinib alone (standard systemic therapy)
干预措施: osimertinib
结局指标
主要结局
intracranial progression-free survival (iPFS)
时间窗: 3 months
Intracranial progression will be assessed at 3-month intervals and is defined as a ≥20% increase in sum longest distance relative to nadir for target lesions (up to a max of 5 lesions; must include at least one lesion increased in size by an absolute value of 5mm), unequivocal progression of non-target lesions, and/or the presence of new lesions, as defined by the RANO-BM working group criteria
次要结局
- Time to CNS progression(9 months)