An Observational, Prospective, Multicenter 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

AstraZeneca1 site in 1 country83 target enrollmentJanuary 5, 2024

ConditionsNon-Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
Enrollment: 83
Locations: 1
Primary Endpoint: Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
Status: Terminated
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

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

Registry

clinicaltrials.gov

Start Date

January 5, 2024

End Date

April 30, 2025

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

Outcomes

Primary Outcomes

Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm

Time Frame: Approximately 6 months

To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD.

Secondary Outcomes

Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation(Approximately 6 months)
Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD(Approximately 6 months)
Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation(Approximately 6 months)
Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score(Approximately 6 months)
Compliance rate of patient-reported symptoms(Approximately 6 months)
Incidence of pneumonitis/ILD per grade(Approximately 6 months)
Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge(Approximately 6 months)
Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD(Approximately 6 months)
Sensitivity, specificity, PPV, NPV and OR of the algorithm(Approximately 6 months)
Change from baseline in symptom severity score(Approximately 6 months)
Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score(Approximately 6 months)
Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events(Approximately 6 months)
Compliance rate of patient collected pulse oximetry assessment(Approximately 6 months)