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 (LOOP)

AstraZeneca

Status: Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: None (Observational Study)

Study type: Observational

Funder types: Industry

Identifiers

NCT06192004

D7680C00001

Details and patient eligibility

About

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.

Full 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 collected prospectively from study sites using eCRFs and remotely from patients using a digital health tool.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must be 18 years of age or older, at the time of signing the ICF (Informed consent).
2. Have histologically or cytologically documented unresectable Stage III or Stage IV NSCLC.
3. 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.
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.

Trial design

83 participants in 1 patient group

Prospective Cohort

Description:

NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.

Treatment:

Other: None (Observational Study)