An observational study in Non-Small Cell Lung Cancer, sponsored by AstraZeneca. Terminated at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by AstraZeneca · Observational
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 83 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.
Other: None (Observational Study)
Not applicable since Observational Study
Also known as: Observational Study
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Approximately 6 months
Change from baseline in symptom severity score
Daily symptom severity rating
Time frame: Approximately 6 months
Compliance rate of patient-reported symptoms
Daily symptom severity rating
Time frame: Approximately 6 months
Compliance rate of patient collected pulse oximetry assessment
Daily pulse oximetry reading
Time frame: 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.
Time frame: Approximately 6 months
Plan to share: 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.
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
AstraZeneca