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

Active, not recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Other: None (Observational Study)

• Registration Number: NCT06192004
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-20
• Study Start: 2024-01-05
• Study First Posted: 2024-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-06-25
• Study Completion: 2025-06-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	None (Observational Study)	NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.

Primary Outcome Measures

Name	Time	Method
Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm	Approximately 6 months	To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD.

Secondary Outcome Measures

Name	Time	Method
Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation	Approximately 6 months	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD	Approximately 6 months	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation	Approximately 6 months	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score	Approximately 6 months	5 Level EuroQoL 5 Dimension Questionnaire
Compliance rate of patient-reported symptoms	Approximately 6 months	Daily symptom severity rating
Incidence of pneumonitis/ILD per grade	Approximately 6 months	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge	Approximately 6 months	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD	Approximately 6 months	The use of corticosteroids, test(s) requirements for diagnosis, hospitalization will be evaluated to characterize the onset and evolution over time of pneumonitis/ILD in patient.
Sensitivity, specificity, PPV, NPV and OR of the algorithm	Approximately 6 months	To assess algorithm performance in identifying Pneumonitis/ILD and other lung/respiratory/thoracic-related events including but not limited to: tumor progression, pneumonia, COVID-19.
Change from baseline in symptom severity score	Approximately 6 months	Daily symptom severity rating
Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score	Approximately 6 months	St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis
Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events	Approximately 6 months	The incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events including but not limited to tumor progression, pneumonia, COVID-19, and associations and correlations with patient-generated data on eCOA will be assessed.
Compliance rate of patient collected pulse oximetry assessment	Approximately 6 months	Daily pulse oximetry reading

Trial Locations

Locations (1)

Research Site; 🇺🇸 Odessa, Texas, United States