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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
. 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.