Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1
NCT ID: NCT07036016
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
67818 participants
OBSERVATIONAL
2015-01-01
2025-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer
NCT07271446
Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21
NCT01714908
EGFR-TKI Combined With Concurrent or Sequential Chemotherapy for Patients of Gradual Progression
NCT03544814
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
NCT02031601
Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive
NCT07063329
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EGFR-TKI
EGFR-TKI
epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)-including gefitinib, erlotinib, afatinib, and osimertinib
PD-1/PD-L1
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)
EGFR-TKI combined with PD-1/PD-L1
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EGFR-TKI
epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)-including gefitinib, erlotinib, afatinib, and osimertinib
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)
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WHUH_2025_06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.