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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Other: None (Observational Study)

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Research Site
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Recruiting
      • Research Site
  • Michigan
    • Troy, Michigan, United States, 48098
      • Recruiting
      • Research Site
  • New Jersey
    • Mickleton, New Jersey, United States, 08056
      • Recruiting
      • Research Site
  • Ohio
    • Massillon, Ohio, United States, 44646
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD; receiving SoC and initiating treatment with an FDA-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule EGFR inhibitor.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Cohort; NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.	Other: None (Observational Study); Not applicable since Observational Study; Other Names: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Change from baseline in symptom severity score	Daily symptom severity rating	Approximately 6 months
Compliance rate of patient-reported symptoms	Daily symptom severity rating	Approximately 6 months
Compliance rate of patient collected pulse oximetry assessment	Daily pulse oximetry reading	Approximately 6 months
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): June 3, 2025
• Study Completion (Estimated): June 3, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pneumonitis; Interstitial lung disease (ILD); Standard-of-Care
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pneumonia
• Other Study ID Numbers: D7680C00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No