Immunotherapy in Lung Cancer: Which Treatment After Immunotherapy Cessation: A Prospective Registry From the European Lung Cancer Working Party
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- to determine the therapeutic landscape after cessation of an immune checkpoint therapy
研究概览
简要总结
Immunotherapy is now a standard of care for first-line and eventually salvage therapy in patients with stage IV NSCLC and as adjuvant after RT-CT for stage III NSCLC.
The aim of the study is determining the therapeutic landscape and the reason for immunotherapy cessation.
详细描述
Patients with stage IV or unresectable not irradiable stage III NSCLC will be registered at the time receiving immunotherapy alone or in combination with chemotherapy.
When IO is stopped, reason for cessation and further treatment will be recorded.
Secondary endpoints are survival after IO cessation, activity of first salvage therapy, disease-free survival after IO cessation in patients receiving no further treatment.
Patients will be centrally registered at the ELCWP headquarter (Institut Jules Bordet, Brussels, Belgium).
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
- •Histological diagnosis of non-small cell lung cancer (NSCLC)
- •Stage IVA/IVB and unresectable and non irradiable stage III NSCLC naïve of immunotherapy.
- •Patients who receive immunotherapy (any type) monotherapy, combined immunotherapy or in combination with chemotherapy for first or second-line treatment.
- •Availability for participating in the detailed follow-up of the protocol.
- •Signed informed consent.
排除标准
- •Patients receiving adjuvant immunotherapy for stage I-III NSCLC are not eligible
- •Tumours for which TNM stage at time of study inclusion cannot be assessed.
- •History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumor (more than 5-year disease free interval).
- •Any type of immunotherapy for previous cancer
结局指标
主要结局
to determine the therapeutic landscape after cessation of an immune checkpoint therapy
时间窗: From IO cessation date up to first treatment whatever the time in-between and up to 5 years
Which treatment is proposed after IO cessation
次要结局
- survival(From IO cessation date up to death or up to 5 years)
- Activity of salvage therapy - response(At the end of cycle 2 or 3 (according to routine local practice), one cycle corresponding to 21 days, up to 6 cycles. assessment will done according to RECIST criteria)
- Disease-free survival(From IO cessation to progression documentation or death or up to 5 years)
- second-line ICI effectiveness - response(From initiation of second-line IO up to 2 years)
- second-line ICI effectiveness - progression-free survival(From initation of second-line ICI up to progression or death and up to 5 years)
- Activity of salvage therapy - progression-free survival(From initation of salvage therapy up to progression or death and up to 5 years)
- Activity of salvage therapy - survival(From initation of second-line ICI up to death and up to 5 years)