MedTrace Logo

Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1

NCT07036016 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67818

Last updated 2025-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

EGFR-TKI

epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)-including gefitinib, erlotinib, afatinib, and osimertinib

DRUG

PD-1/PD-L1 inhibitor

ICIs such as nivolumab, pembrolizumab, and atezolizumab-targeting the programmed cell death 1 (PD-1) or its ligand (PD-L1)

DRUG

EGFR-TKI combined with PD-1/PD-L1

epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)-including gefitinib, erlotinib, afatinib, and osimertinib combined with ICIs such as nivolumab, pembrolizumab, and atezolizumab-targeting the programmed cell death 1 (PD-1) or its ligand (PD-L1)

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2024-12-31
Completion
2025-05-01
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07036016 on ClinicalTrials.gov