Study Stopped
Observed event rate was below the rate required to meet study objectives.
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
1 other identifier
observational
83
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedMay 4, 2026
April 1, 2026
1.3 years
November 28, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Sensitivity, specificity, PPV, NPV and OR of the algorithm
Approximately 6 months
Incidence of pneumonitis/ILD per grade
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
Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation
Approximately 6 months
- +8 more secondary outcomes
Study Arms (1)
Prospective Cohort
NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.
Interventions
Not applicable since Observational Study
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (23)
Research Site
Los Angeles, California, 90027, United States
Research Site
Los Angeles, California, 90033, United States
Research Site
Denver, Colorado, 80204, United States
Research Site
Golden, Colorado, 80222, United States
Research Site
Miami Lakes, Florida, 33014, United States
Research Site
Skokie, Illinois, 60076, United States
Research Site
Ames, Iowa, 50010-3014, United States
Research Site
Covington, Louisiana, 70433, United States
Research Site
Troy, Michigan, 48098, United States
Research Site
Florham Park, New Jersey, 07932, United States
Research Site
Mickleton, New Jersey, 08056, United States
Research Site
Shirley, New York, 11967, United States
Research Site
Westbury, New York, 11590, United States
Research Site
Canton, Ohio, 44708, United States
Research Site
Canton, Ohio, 44710, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Massillon, Ohio, 44646, United States
Research Site
York, Pennsylvania, 17403, United States
Research Site
Austin, Texas, 78745, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
Houston, Texas, 77024, United States
Research Site
Longview, Texas, 75601, United States
Research Site
Odessa, Texas, 79902, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2023
First Posted
January 5, 2024
Study Start
January 5, 2024
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.