Non-Small Cell Lung Cancer
Conditions
Keywords
Standard-of-Care, pneumonitis, Interstitial lung disease (ILD)
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.
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.
Interventions
OTHERNone (Observational Study)
Not applicable since Observational Study
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm | Approximately 6 months | To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity, PPV, NPV and OR of the algorithm | Approximately 6 months | 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. |
| Incidence of pneumonitis/ILD per grade | Approximately 6 months | To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC. |
| Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD | Approximately 6 months | To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC. |
| Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation | Approximately 6 months | To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC. |
| Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation | Approximately 6 months | To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC. |
| Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge | Approximately 6 months | To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC. |
| Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD | Approximately 6 months | 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. |
| Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score | Approximately 6 months | St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis |
| Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score | Approximately 6 months | 5 Level EuroQoL 5 Dimension Questionnaire |
| Change from baseline in symptom severity score | Approximately 6 months | Daily symptom severity rating |
| Compliance rate of patient-reported symptoms | Approximately 6 months | Daily symptom severity rating |
| Compliance rate of patient collected pulse oximetry assessment | Approximately 6 months | Daily pulse oximetry reading |
| Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events | Approximately 6 months | 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. |
Countries
United States
Outcome results
None listed