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Completed

NCT Number: NCT07036016

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Non-NSCLC Indications: Cases not related to NSCLC (e.g., other cancer types).
  • Incomplete Treatment Data: Patients with missing or unclear treatment exposure information (e.g., use of unrelated therapies).
  • Duplicate Reports: Duplicate adverse event reports were excluded.

Treatment and study plan

EGFR-TKI

Drug

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

PD-1/PD-L1 inhibitor

Drug

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

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

Drug

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)

Primary outcomes

  1. Incidence of reported interstitial pneumonitis and adjusted odds ratios (aORs) derived from multivariable logistic regression analyses.

    Time frame: From January 1, 2015, and December 31, 2024

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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