Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Observed event rate was below the rate required to meet study objectives.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| None (Observational Study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prospective Cohort
- description
- NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.
- interventionNames
- Other: None (Observational Study)
Primary outcomes (1)
- measure
- Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm
- timeFrame
- Approximately 6 months
- description
- To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD.
Secondary outcomes (13)
- measure
- Sensitivity, specificity, PPV, NPV and OR of the algorithm
- timeFrame
- Approximately 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available