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NCT06192004Terminated

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, 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

Source: ClinicalTrials.gov · Last updated 4 May 2026

Reason given: Observed event rate was below the rate required to meet study objectives.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Observational
Enrollment
83 (actual)
First submitted
28 Nov 2023
Start date
5 Jan 2024
Primary completion date
30 Apr 2025
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT06192004

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in a research study or a clinical trial.
  • 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.

Other

  • 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.
  • More than 2 weeks have passed from the administration of the first dose of qualifying FDA-approved treatment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-AmesUnited StatesUnknown status
-AustinUnited StatesUnknown status
-CantonUnited StatesUnknown status
-CincinnatiUnited StatesUnknown status
-CovingtonUnited StatesUnknown status
-DallasUnited StatesUnknown status
-DenverUnited StatesUnknown status
-Florham ParkUnited StatesUnknown status
-GoldenUnited StatesUnknown status
-HoustonUnited StatesUnknown status
-LongviewUnited StatesUnknown status
-Los AngelesUnited StatesUnknown status
-MassillonUnited StatesUnknown status
-Miami LakesUnited StatesUnknown status
-MickletonUnited StatesUnknown status
-OdessaUnited StatesUnknown status
-ShirleyUnited StatesUnknown status
-SkokieUnited StatesUnknown status
-TroyUnited StatesUnknown status
-WestburyUnited StatesUnknown status
-YorkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.