IRB Study Number D7680C00001
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective
To gather evidence in the context of lung cancer to complement the development of the algorithm to identify patients at risk of pneumonitis/ILD.
Secondary Objectives
To assess algorithm performance in identifying Pneumonitis/ILD and other lung/respiratory/thoracic-related events including but not limited to: tumor progression, pneumonia, COVID-19.
To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
To assess the relationship between the development of pneumonitis/ILD and patient-reported symptoms (eg, cough severity), patient-collected signs with pulse oximeter (eg, respiration rate after exertion), and various physiological markers available per SoC.
To measure patients’ adherence with eCOA completion over time.
To assess the relationship between the development of pneumonitis/ILD and other lung/respiratory/thoracic-related events and patient-reported symptoms (eg, cough severity), patient-collected signs with pulse oximeter (eg, respiration rate after exertion), and various physiological markers available per SoC.
Inclusion Criteria
1 Patient must be 18 years of age or older, at the time of signing the ICF.
2 Have histologically or cytologically documented unresectable Stage III or Stage IV NSCLC.
3 Are initiating treatment with an FDA-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule EGFR inhibitor.
4 Minimum life expectancy of 12 weeks at the time of signing the ICF.
5 Able and willing to provide written signed informed consent.
6 Able and willing to use the digital health tool throughout the duration of the study.
Exclusion Criteria
1 Concurrent participation in a research study or a clinical trial.
2 Unable to receive SoC for the treatment and management of NSCLC including clinical or imaging assessments for up to 6 months.
3 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.
4 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.
5 More than 2 weeks have passed from the administration of the first dose of qualifying FDA-approved treatment.
