Non-Small Cell Lung CancerLOOPNCT06192004
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
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 23 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- None (Observational Study)
- How many people
- 83 participants
- Where
- 23 sitesUnited States
- Study dates
- 5 Jan 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Research Site
Ames, Iowa, 50010-3014
Research Site
Austin, Texas, 78745
Research Site
Canton, Ohio, 44708
Research Site
Canton, Ohio, 44710
Research Site
Cincinnati, Ohio, 45219
Research Site
Covington, Louisiana, 70433
Research Site
Dallas, Texas, 75246
Research Site
Denver, Colorado, 80204
Research Site
Florham Park, New Jersey, 07932
Research Site
Golden, Colorado, 80222
Research Site
Houston, Texas, 77024
Research Site
Longview, Texas, 75601
Research Site
Los Angeles, California, 90027
Research Site
Los Angeles, California, 90033
Research Site
Massillon, Ohio, 44646
Research Site
Miami Lakes, Florida, 33014
Research Site
Mickleton, New Jersey, 08056
Research Site
Odessa, Texas, 79902
Research Site
Shirley, New York, 11967
Research Site
Skokie, Illinois, 60076
Research Site
Troy, Michigan, 48098
Research Site
Westbury, New York, 11590
Research Site
York, Pennsylvania, 17403
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- None (Observational Study)
- Keywords
- Standard-of-Care, pneumonitis, Interstitial lung disease (ILD)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pneumonia, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational Study)Other
Also called Observational Study
Not applicable since Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD. Receives: Other: None (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 6 months
Secondary outcomes (13)
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.
Measured: Approximately 6 months
Incidence of pneumonitis/ILD per grade
To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Approximately 6 months
Change from baseline in symptom severity score
Daily symptom severity rating
Measured: Approximately 6 months
Compliance rate of patient-reported symptoms
Daily symptom severity rating
Measured: Approximately 6 months
Compliance rate of patient collected pulse oximetry assessment
Daily pulse oximetry reading
Measured: 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.
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start5 Jan 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: Observed event rate was below the rate required to meet study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192004
- Sponsor's protocol ID
- D7680C00001
- Acronym
- LOOP
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06192004
- Acronym / sponsor ID
- LOOP / D7680C00001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Standard-of-Care, pneumonitis, Interstitial lung disease (ILD)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Observed event rate was below the rate required to meet study objectives.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Other: None (Observational Study)NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational Study)Also: Observational StudyNot applicable since Observational Study | Other | Prospective Cohort |
Primary outcome
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.
13 secondary outcomes
Sensitivity, specificity, PPV, NPV and OR of the algorithm
Time frame: Approximately 6 months
Incidence of pneumonitis/ILD per grade
Time frame: Approximately 6 months
Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD
Time frame: Approximately 6 months
Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation
Time frame: Approximately 6 months
Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation
Time frame: Approximately 6 months
Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge
Time frame: Approximately 6 months
Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD
Time frame: Approximately 6 months
Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score
Time frame: Approximately 6 months
Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score
Time frame: Approximately 6 months
Change from baseline in symptom severity score
Time frame: Approximately 6 months
Compliance rate of patient-reported symptoms
Time frame: Approximately 6 months
Compliance rate of patient collected pulse oximetry assessment
Time frame: Approximately 6 months
Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events
Time frame: Approximately 6 months
Results and safety
The study was stopped early (reason given: Observed event rate was below the rate required to meet study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Redacted CSR SynopticLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Observed event rate was below the rate required to meet study objectives.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm (time frame: Approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.