NCT04216121招募中不适用
Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- PFS 2
研究概览
简要总结
To determine whether in patients with EGFR mutated advanced NSCLC and osimertinib as first-line treatment, the (repeated) use of LAT to ≤ 3 OP lesions and continuation of first-line osimertinib, improves the median progression-free survival by more than 3 months (i.e. PFS2-PFS1 = >3 months).
详细描述
The (repeated) use of LAT to ≤ 3 OP lesions with continuation of first-line osimertinib, is endorsed by international guidelines (NCCN, ESMO).
In this phase IIb prospective non-randomized observational trial, we want to document the benefit of LAT in this patient cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female, ≥ 18 years of age
- •Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib
- •Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.
- •Confirmed OPD defined as ≤ 3 intra- and extracranial sites of progressive disease. OP may be defined as progression of an individual metastasis according to RECIST or on 2 consecutive imaging studies at least 2 months apart with a minimum of 5mm increase in size from baseline or an unambiguous development of a new metastatic lesion with a grand total of 3 lesions. All sites must be visible, imaging defined targets, not previously treated with radiation or radiofrequency and suitable for treatment with LAT as determined by the local multi-disciplinary team (MDT).
- •Adequate baseline organ function to allow LAT to all the OP targets.
- •Predicted life expectancy ≥ 6 months
- •Karnofsky Index ≥ 60% and ECOG 0-2
- •Provision of written informed consent
- •Female participants must be surgically sterile or postmenopausal if SBRT is planned to the abdominal area or must agree to use effective contraception during the period of therapy.
排除标准
- •> 3 sites of progressive disease
- •Oligoprogressive metastases not amenable to LAT
- •Radiotherapy or radiofrequency ablation near the OP lesion prior to the inclusion in the LAT-FLOSI study
- •Co-morbidities considered clinically precluding the safe use of LAT
- •Any psychological, sociological or geographical issue potentially hampering compliance with the study
结局指标
主要结局
PFS 2
时间窗: Time from start of osimertinib until first PD after LAT or death whichever comes first, up to 3 year after LAT
Progression Free Survival 2
次要结局
- Patterns of disease progression(Time from LAT until disease progression or death whichever comes first, up to 3 years after LAT)
- Radiotherapy induced toxicity(Change in toxicity measured from baseline up to 3 years after radiotherapy)
- Time to next line systemic therapy(Time from LAT until initiation of next line systemic therapy or death whichever comes first, up to 3 years after LAT)
- Quality of life(Change in quality of life measured from baseline up to 3 years after radiotherapy)
研究者
研究点 (1)
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