Clinical trial NCT06192004: 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
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Small Cell Lung Cancer
Keywords: Standard-of-Care
pneumonitis
Interstitial lung disease (ILD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Sensitivity, specificity, PPV, NPV and OR of the algorithm
timeFrame: Approximately 6 months
measure: Incidence of pneumonitis/ILD per grade
timeFrame: Approximately 6 months
measure: Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD
timeFrame: Approximately 6 months
measure: Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation
timeFrame: Approximately 6 months
measure: Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation
timeFrame: Approximately 6 months
measure: Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge
timeFrame: Approximately 6 months
measure: Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD
timeFrame: Approximately 6 months
measure: Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score
timeFrame: Approximately 6 months
measure: Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score
timeFrame: Approximately 6 months
measure: Change from baseline in symptom severity score
timeFrame: Approximately 6 months
measure: Compliance rate of patient-reported symptoms
timeFrame: Approximately 6 months
measure: Compliance rate of patient collected pulse oximetry assessment
timeFrame: Approximately 6 months
measure: Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Golden
country: United States
facility: Research Site
state: Colorado
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: Ames
country: United States
facility: Research Site
state: Iowa
city: Covington
country: United States
facility: Research Site
state: Louisiana
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Florham Park
country: United States
facility: Research Site
state: New Jersey
city: Mickleton
country: United States
facility: Research Site
state: New Jersey
city: Shirley
country: United States
facility: Research Site
state: New York
city: Westbury
country: United States
facility: Research Site
state: New York
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Massillon
country: United States
facility: Research Site
state: Ohio
city: York
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Longview
country: United States
facility: Research Site
state: Texas
city: Odessa
country: United States
facility: Research Site
state: Texas
Study officials:
References: