Non-Small Cell Lung Cancer (NSCLC)NCT07036016
Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1
An observational study of Non-Small Cell Lung Cancer (NSCLC), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- EGFR-TKI, PD-1/PD-L1 inhibitor and EGFR-TKI combined with PD-1/PD-L1
- How many people
- 67,818 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
Read more
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)
- Being tested
- EGFR-TKI, PD-1/PD-L1 inhibitor, EGFR-TKI combined with PD-1/PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR-TKIDrug
epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)-including gefitinib, erlotinib, afatinib, and osimertinib
PD-1/PD-L1 inhibitorDrug
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-L1Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| EGFR-TKI | Not described Receives: Drug: EGFR-TKI | |
| PD-1/PD-L1 | Not described Receives: Drug: PD-1/PD-L1 inhibitor | |
| EGFR-TKI combined with PD-1/PD-L1 | Not described Receives: Drug: EGFR-TKI combined with PD-1/PD-L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reported interstitial pneumonitis and adjusted odds ratios (aORs) derived from multivariable logistic regression analyses.
Measured: From January 1, 2015, and December 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67,818 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036016
- Sponsor's protocol ID
- WHUH_2025_06
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07036016
- Acronym / sponsor ID
- WHUH_2025_06
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67,818 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EGFR-TKI | – | Drug: EGFR-TKI |
| PD-1/PD-L1 | – | Drug: PD-1/PD-L1 inhibitor |
| EGFR-TKI combined with PD-1/PD-L1 | – | Drug: EGFR-TKI combined with PD-1/PD-L1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR-TKIepidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)-including gefitinib, erlotinib, afatinib, and osimertinib | Drug | EGFR-TKI |
| PD-1/PD-L1 inhibitorICIs such as nivolumab, pembrolizumab, and atezolizumab-targeting the programmed cell death 1 (PD-1) or its ligand (PD-L1) | Drug | PD-1/PD-L1 |
| EGFR-TKI combined with PD-1/PD-L1epidermal 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) | Drug | EGFR-TKI combined with PD-1/PD-L1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer (NSCLC), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.