An Observational Cohort Study of Patients With Newly Diagnosed Unresectable Stage IIIB, IIIC, or IV Non-Small-Cell Lung Cancer (NSCLC) in China
概览
- 阶段
- 不适用
- 干预措施
- Prospective cohort (Cohort 2)
- 疾病 / 适应症
- Carcinoma, Non-Small-Cell Lung
- 发起方
- Hoffmann-La Roche
- 入组人数
- 1200
- 试验地点
- 22
- 主要终点
- Median Overall Survival (OS)
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
This is a multicenter, observational cohort study in China with both primary prospective data collection and retrospective collection of prior treatment information from medical records, which enrolls and follows patients who are newly diagnosed with unresectable stage IIIB/IIIC/IV Non-Small-Cell Lung Cancer (NSCLC) in the selected sites.
This study aims to describe the clinical practice and long-term survival benefits of patients newly diagnosed with unresectable stage IIIB/IIIC/IV NSCLC. The study also seeks to explore the condition of biomarker tests utilization, and to assess potential economic impact on patients in the real world. The safety related events will also be summarized in this study.
研究者
入排标准
入选标准
- •Participants who have diagnosed with unresectable stage IIIB/IIIC/IV NSCLC
- •Participants who have been diagnosed six months before the start of the study were required to have two complete tumor assessments within at least 6 months intervals after the diagnosis
- •Participants who were newly diagnosed within six months before the start of the study were required to have complete baseline information (see section 6.4.1)
- •Participants who have received standard first-line treatment defined by guideline CSCO (https://www.csco.org.cn/cn/index.aspx) and NCCN (https://www.nccn.org/)
- •Participants who are newly diagnosed with unresectable Stage IIIB/IIIC/IV NSCLC after the start of the study
- •Participants who are able to be followed up by the participating site
- •Participants planned to receive first line anti-cancer treatment targeting unresectable stage IIIB/IIIC/IV NSCLC in the study site after study initiation
排除标准
- •Participants who have received prior systematic treatment for unresectable Stage IIIB/IIIC/IV NSCLC
- •Participants who have participated in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB/IIIC/IV NSCLC
研究组 & 干预措施
Prospective cohort (Cohort 2)
The prospective enrollment of new cases of unresectable stage IIIB/IIIC/IV NSCLC will end up to 1 year after the first patient is enrolled (FPI) in Cohort 2.
Retrospective cohort (Cohort 1)
All cases of unresectable stage IIIB/IIIC/IV NSCLC newly diagnosed between January 2020 and the date of the study initiation will be collected. All these participants will be followed up until death or lost-to-follow-up or until 12 months after the last participant is enrolled in cohort 2 in the study.
结局指标
主要结局
Median Overall Survival (OS)
时间窗: Up to 2 years
OS is defined as the time from the date of the first administration of anti-cancer treatment until the date of death from any cause.
Median weeks on first-line treatment
时间窗: Up to 2 years
First-line treatment will be reported by class of treatment. Median, minimum, and maximum values will be used to summarize the number of weeks on the first line of treatment.
次要结局
- Tumor Molecular Characteristics, measured by the presence of defined biomarkers(Up to 2 years)
- Anti-cancer Treatment Duration(Up to 2 years)
- Number of Cycles of Anti-cancer Treatment(Up to 2 years)
- Treatment Cost to the Participant, measured by accrued fees; pharmacy fee, treatment fee, examinations fee, insurance coverage, and other medical costs(Up to 2 years)
- Number of participants with at least one adverse event, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)(Up to 2 years)
- Number of Dose Modifications of Anti-Cancer Treatment(Up to 2 years)