An Observational, Prospective, Multicenter Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating an Approved Therapy With Risk of Pneumonitis/ILD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 83
- 试验地点
- 24
- 主要终点
- Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
研究概览
简要总结
This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution.
Patients initiating treatment for non-small cell lung cancer (NSCLC) will be prospectively followed to characterize risk factors, signs, and symptoms leading to onset, diagnosis, and treatment of pneumonitis/ILD should it occur.
详细描述
This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution.
Data will be collected prospectively from study sites using eCRFs and remotely from patients using a digital health tool.
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
- •Patient must be 18 years of age or older, at the time of signing the ICF (Informed consent).
- •Have histologically or cytologically documented unresectable Stage III or Stage IV NSCLC.
- •Are initiating treatment with an FDA (Food and Drug Administration)-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule EGFR inhibitor.
- •Minimum life expectancy of 12 weeks at the time of signing the ICF.
- •Able and willing to provide written signed informed consent.
- •Able and willing to use the digital health tool throughout the duration of the study.
排除标准
- •Concurrent participation in a research study or a clinical trial.
- •Unable to receive SoC for the treatment and management of NSCLC including clinical or imaging assessments for up to 6 months.
- •Judgment by the Investigator that the patient is unsuitable to participate in the study and/or the patient is unlikely to comply with study procedures and requirements.
- •Confirmed or suspected diagnosis of pneumonitis/ILD at the time of signing ICF. This does not apply to historical pneumonitis/ILD events that have resolved prior to signing ICF.
- •More than 2 weeks have passed from the administration of the first dose of qualifying FDA-approved treatment.
研究组 & 干预措施
Prospective Cohort
NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.
干预措施: None (Observational Study) (Other)
结局指标
主要结局
Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
时间窗: Approximately 6 months
To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD.
次要结局
- Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation(Approximately 6 months)
- Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD(Approximately 6 months)
- Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation(Approximately 6 months)
- Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score(Approximately 6 months)
- Compliance rate of patient-reported symptoms(Approximately 6 months)
- Incidence of pneumonitis/ILD per grade(Approximately 6 months)
- Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge(Approximately 6 months)
- Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD(Approximately 6 months)
- Sensitivity, specificity, PPV, NPV and OR of the algorithm(Approximately 6 months)
- Change from baseline in symptom severity score(Approximately 6 months)
- Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score(Approximately 6 months)
- Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events(Approximately 6 months)
- Compliance rate of patient collected pulse oximetry assessment(Approximately 6 months)