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

Non-Small Cell Lung Cancer Clinical Trial

— LOOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192004
• Other study ID #: D7680C00001
• Status: Recruiting
• Start date: January 5, 2024
• Est. completion date: June 3, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 3, 2025
• Est. primary completion date: June 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Pneumonia

Intervention

Other:
• None (Observational Study)
Not applicable since Observational Study

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Canton	Ohio
United States	Research Site	Canton	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	El Paso	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Longview	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Massillon	Ohio
United States	Research Site	Mickleton	New Jersey
United States	Research Site	Skokie	Illinois
United States	Research Site	Troy	Michigan
United States	Research Site	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm	To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD.	Approximately 6 months
Secondary	Sensitivity, specificity, PPV, NPV and OR of the algorithm	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.	Approximately 6 months
Secondary	Incidence of pneumonitis/ILD per grade	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.	Approximately 6 months
Secondary	Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.	Approximately 6 months
Secondary	Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.	Approximately 6 months
Secondary	Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.	Approximately 6 months
Secondary	Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge	To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.	Approximately 6 months
Secondary	Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD	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.	Approximately 6 months
Secondary	Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score	St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis	Approximately 6 months
Secondary	Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score	5 Level EuroQoL 5 Dimension Questionnaire	Approximately 6 months
Secondary	Change from baseline in symptom severity score	Daily symptom severity rating	Approximately 6 months
Secondary	Compliance rate of patient-reported symptoms	Daily symptom severity rating	Approximately 6 months
Secondary	Compliance rate of patient collected pulse oximetry assessment	Daily pulse oximetry reading	Approximately 6 months
Secondary	Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events	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.	Approximately 6 months