NCT07036016Completed
Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1
Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1: A Retrospective Observational Study In Patients With Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 25 Jun 2025
Brief summary (registry, in English)
Importance: EGFR tyrosine kinase inhibitors (EGFR-TKIs) and PD-1/PD-L1 immune checkpoint inhibitors are widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety profile of their combination-particularly the risk of interstitial pneumonitis (IP)-remains unclear. Objective: To evaluate the incidence and risk of interstitial pneumonitis associated with EGFR-TKIs when combined with PD-1/PD-L1 inhibitors, using real-world pharmacovigilance data. Design, Setting, and Participants: This retrospective observational study analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS) between January 1, 2015, and December 31, 2024. A total of 67,818 NSCLC cases were included, categorized by treatment with EGFR-TKIs, PD-1/PD-L1 inhibitors, combined therapy, or the other therapies. Exposure: NSCLC patients receiving EGFR-TKI PD-1/PD-L1 inhibitors, combined therapy, or the other therapies were compared to those not receiving such treatment. Main Outcome and Measures: Incidence of reported interstitial pneumonitis and adjusted odds ratios (aORs) derived from multivariable logistic regression analyses.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 67818 (actual)
- First submitted
- 17 Jun 2025
- Start date
- 1 Jan 2015
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07036016
What you commit to
- Study type: Observational
- Participants enrolled: 67818
- From 1 Jan 2015 to the primary completion date, 31 Dec 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incomplete Treatment Data: Patients with missing or unclear treatment exposure information (e.g., use of unrelated therapies).
Other illness
- Non-NSCLC Indications: Cases not related to NSCLC (e.g., other cancer types).
Other
- Duplicate Reports: Duplicate adverse event reports were excluded.
Who the study is looking for
- Patients with non-small cell lung cancer (NSCLC).
- Received at least one EGFR-TKI (gefitinib, erlotinib, afatinib, osimertinib). Or received at least one PD-1/PD-L1 inhibitor (nivolumab, pembrolizumab, atezolizumab, durvalumab). Or received combination therapy with both EGFR-TKIs and PD-1/PD-L1 inhibitors. Or received the other therapies.
- Cases reported in the FDA Adverse Event Reporting System (FAERS) between January 1, 2015, and December 31, 2024.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.