Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients - REMAIN Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 25
- 主要终点
- The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy
研究概览
简要总结
Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice
详细描述
This study will include patients
- who have already received adjuvant osimertinib and who relapsed at the end of the treatment (off-treatment recurrence) and patients
- who relapsed during the treatment (on-treatment recurrence). Patients could be enrolled at the time or after the recurrence. Data regarding clinical features for each patient, including demographics and comorbidities, and clinical outcomes of adjuvant osimertinib will be collected.
NGS analysis will be centrally performed on tissue biopsy and/or liquid biopsy collected at the time of recurrence in EGFR-mutated NSCLC treated with adjuvant osimertinib. NGS will be also centrally performed on tissue samples collected at the time of surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years
- •Diagnosis of radically resected IB-IIIA NSCLC with EGFR activating mutation
- •Treatment with adjuvant osimertinib (starting from September 2022, date of approval) according to clinical practice
- •Recurrence of disease during or after adjuvant therapy with osimertinib received according to clinical practice
- •Availability of tissue and/or liquid biopsy sample collected at the time of recurrence
- •Signed informed consent.
排除标准
- •Unavailability of tissue and/or liquid biopsy sample collected at the time of recurrence
- •Concomitant synchronous malignancies aside from NSCLC or any concurrent and/or active malignancy that has required treatment within 2 years
- •Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site).
结局指标
主要结局
The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy
时间窗: 3 years
The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy
次要结局
- Secondary endpoint(3 years)