Status:
TERMINATED
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
Lead Sponsor:
AstraZeneca
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
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 collect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT06192004
Start Date
January 5 2024
End Date
April 30 2025
Last Update
June 3 2025
Active Locations (23)
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1
Research Site
Los Angeles, California, United States, 90027
2
Research Site
Los Angeles, California, United States, 90033
3
Research Site
Denver, Colorado, United States, 80204
4
Research Site
Golden, Colorado, United States, 80222