Assessment and Follow-up of Patients With KRAS G12C-mutated Metastatic Non-Small Cell Lung Cancer Who Received Sotorasib as Part of the French Early Access Program (ATU)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 458
- 试验地点
- 3
- 主要终点
- Duration of response
研究概览
简要总结
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.
详细描述
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.
The objective of this retrospective observational, multicenter, cohort study is to describe, in real life, the characteristics and evolution of NSCLC patients with a KRAS G12C mutation, treated with sotorasib in the framework of the cohort ATU in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Stage IV NSCLC at time of initiation of treatment with sotorasib
- •Presence of KRAS G12C mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed)
- •Patients who received at least one dose of the treatment with sotorasib as part of the French Early Access Program (ATU program)
- •Patients who were informed about the study and do not object for their data to be collected
- •Age > 18 years
排除标准
- •Patients enrolled in a sotorasib clinical trial
- •Patients with a psychiatric history that hinders the comprehension of the information leaflet
- •Patients under curatorship or guardianship
- •Unable to obtain data collection
结局指标
主要结局
Duration of response
时间窗: through study completion, an average of 1.5 year
Duration of response will be defined as the time from the date of the first documented response (complete or partial) to the earliest date of disease progression
Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib
时间窗: 6 months
Stage cTNM, smoking habits, PS, presence of brain metastasis, gender, age, histological, KRAS and other biomarkers status
Real-world progression-free survival (rwPFS)
时间窗: through study completion, an average of 1.5 year
rwPFS will be defined as the time from the date of the first dose of treatment with sotorasib to the date of first occurrence of disease progression (defined by the treating physician) or death from any cause during the study
Duration of treatment with sotorasib beyond 1rst progression
时间窗: through study completion, an average of 1.5 year
Duration of treatment with sotorasib beyond progression will be defined as time between first occurrence of disease progression and treatment discontinuation
Description of treatments received before and after sotorasib treatment
时间窗: through study completion, an average of 1.5 year
Description of treatments received before and after sotorasib treatment
Overall survival (OS)
时间窗: through study completion, an average of 1.5 year
OS will be determined as the time from the date of first dose of treatment with sotorasib to the date of death due to any cause during the study
Duration of treatment with sotorasib
时间窗: through study completion, an average of 1.5 year
Duration of treatment is defined as the time from the date of first dose of treatment with sotorasib to the date of discontinuation of treatment with sotorasib or death from any cause during the study
Best response (complete response, partial response, stable disease, progression)
时间窗: through study completion, an average of 1.5 year
Best response will be defined as the best response recorded from the start of treatment with sotorasib until disease progression or start of further anti-cancer treatment
次要结局
未报告次要终点