A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment
概览
- 阶段
- 2 期
- 干预措施
- Cohort 1
- 疾病 / 适应症
- Non-small Cell Lung Cancer
- 发起方
- Hunan Province Tumor Hospital
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recurrence gene profiles
- 状态
- 招募中
- 最后更新
- 19天前
概览
简要总结
This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.
详细描述
This is a multicenter, real-world, retrospective observational study designed to investigate the genomic landscape of recurrence in patients with early-stage (clinical stage IB-IIIA) non-small cell lung cancer harboring EGFR-sensitizing mutations who received adjuvant osimertinib. A total of 60 patients with resectable EGFR-sensitizing mutation-positive NSCLC (exon 19 deletion or exon 21 L858R) are expected to be included and classified into two cohorts. Cohort 1 consists of 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib, and Cohort 2 consists of 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed. The primary endpoint is to evaluate the genomic landscape of recurrence during or after adjuvant osimertinib treatment in patients with resectable NSCLC harboring EGFR-sensitizing mutations. The secondary endpoints are to explore the genomic profiles of recurrence in subgroups with different recurrence patterns (local recurrence versus distant metastasis) during or after adjuvant osimertinib treatment, and to describe the treatment patterns used in real-world clinical practice after disease progression. The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression.
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital
入排标准
入选标准
- •Informed consent signed;
- •Age ≥ 18 years;
- •Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
- •Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
- •Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
- •Recurrence after/on Osimertinib treatment according to RECIST 1.1;
- •NGS gene test report (tumor or blood sample) at the time of recurrence;
- •Receiving or not receiving neoadjuvant treatment before surgery.
排除标准
- •Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
- •Received adjuvant therapy other than that specified in the ADAURA study;
- •No NGS test report at recurrence;
- •History of other malignant tumors within 2 years;
- •Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.
研究组 & 干预措施
Cohort 1
consists of 30 patients who experienced a recurrence more than 6 months after completing 3 years of adjuvant osimertinib.
Cohort 2
consists of 30 patients with recurrence during adjuvant osimertinib treatment.
结局指标
主要结局
Recurrence gene profiles
时间窗: Time from first subject dose to study completion, or up to 36 month
To assess the recurrence gene profiles of adjuvant Osimertinib therapy
Recurrence gene profiles
时间窗: From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.
To assess the recurrence gene profiles of adjuvant Osimertinib therapy
次要结局
- Subsequent treatment patterns(Time from first subject dose to study completion, or up to 36 month)
- Recurrence gene profiles in patients with different recurrence types (local /distant)(Time from first subject dose to study completion, or up to 36 month)
- Recurrence gene profiles in patients with different recurrence types (local /distant)(From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records)
- Subsequent treatment patterns(From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records)