Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating … (NCT06192004) | Clinical Trial Compass
TerminatedNot Applicable
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
Stopped: Observed event rate was below the rate required to meet study objectives.
United States83 participantsStarted 2024-01-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
✕. 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.