NSCLC, Non Small Cell Lung CancerNCT06751108
Impact of Concomitant Use of Steroids and Immune-Checkpoint Inhibitors on Survival Outcomes in NSCLC Patients
An observational study of NSCLC, Non Small Cell Lung Cancer, run by Seoul National University at 1 site in South Korea.
Trial summary
The goal of this observational study is to assess the effects of systemic corticosteroid use during immune checkpoint inhibitor (ICI) therapy in patients with non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NSCLC, Non Small Cell Lung Cancer
- What is being tested?
- Corticosteroids (CS) and Immune Checkpoint Inhibitors
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be established by constructing cohorts from patients treated at the following four hospitals: Seoul National University Hospital, Bundang Seoul National University Hospital, Pusan National University Hospital, and the Seoul Catholic Medical Center of Korea.
Who may be able to join
- Patients who received immune checkpoint inhibitor (ICI) therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab) for the first time between December 31, 2014 and December 31, 2021.
- Patients diagnosed with non-small cell lung cancer (NSCLC) within 2 years prior to the date of first ICI administration.
Who cannot join
- Patients with documented pregnancy within 180 days prior to the enrollment date.
- Patients who were under 18 years of age or over 100 years of age at the time of enrollment.
- Patients with a history of any primary malignancy other than lung cancer within 2 years prior to the enrollment date.
- Patients who received concomitant anticancer therapies (taxane, platinum, pemetrexed, etoposide, doxorubicin, gemcitabine, irinotecan, vinorelbine, vinblastine, or bevacizumab) at the index date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Concomitant Use of Steroids and Immune-Checkpoint Inhibitors on Survival Outcomes in NSCLC Patients: a Multicenter Target Trial Emulation Study Utilizing EHR-based Common Data Models
The goal of this observational study is to assess the effects of systemic corticosteroid use during immune checkpoint inhibitor (ICI) therapy in patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is:
Does the use of systemic corticosteroids during the initial continuous administration of ICI therapy affect overall survival (OS) and treatment outcomes in NSCLC patients?
Participants who received ICI therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab) between December 31, 2014, and December 31, 2021, as part of their routine medical care, will be included. Patient data will be analyzed retrospectively using clinical data from five institutions, and a 1:1 propensity score matching method will be employed to balance the baseline characteristics between groups. Statistical analyses will focus on overall survival, time-to-next-treatment (TNT), and metastasis-free survival (MFS).
Read the detailed description
Purposive sampling was employed to select participants who met the specific inclusion criteria, focusing on patients diagnosed with non-small cell lung cancer (NSCLC) and treated with immune checkpoint inhibitors (ICI) (nivolumab, pembrolizumab, atezolizumab, or durvalumab) during routine clinical practice. The study specifically targets patients who received their first ICI therapy between December 31, 2014, and December 31, 2021. Participants are restricted to those diagnosed with NSCLC within 2 years prior to the date of first ICI administration. Patients with documented pregnancy within 180 days prior to the enrollment date were excluded, as were those under 18 years of age or over 100 years of age at the time of enrollment. Individuals with a history of any primary malignancy other than lung cancer within 2 years prior to the enrollment date and those who received concomitant anticancer therapies such as taxane, platinum, pemetrexed, etoposide, doxorubicin, gemcitabine, irinotecan, vinorelbine, vinblastine, or bevacizumab at the index date were also excluded. All participants were identified retrospectively from clinical data models (CDM) or electronic medical records (EMRs) across five institutions: Seoul National University Hospital, Bundang Seoul National University Hospital, Pusan National University Hospital, and the Catholic Medical Center of Korea. To minimize selection bias inherent to observational studies, time-dependent propensity score matching was performed, simulating pseudo-randomization to balance baseline characteristics between groups.
- Conditions
- NSCLC, Non Small Cell Lung Cancer
- Being tested
- Corticosteroids (CS), Immune Checkpoint Inhibitors
- Keywords
- NSCLC, Non small cell lung cancer, ICI, Immune check point inhibitor, corticosteroid
- 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.
Corticosteroids (CS)Drug
Concomitant use of immune checkpoint inhibitors and corticosteroids
Immune Checkpoint InhibitorsDrug
Non-concomitant use of corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Steroid Concomitant Group | Patients who received systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors. Receives: Drug: Corticosteroids (CS); Drug: Immune Checkpoint Inhibitors | |
| Steroid Non-Concomitant Group | Patients who did not receive systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors. Receives: Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From index date to the end of 2 years follow-up
Secondary outcomes (3)
Metastasis-free survival
Duration of survival without distant metastasis
Measured: From index date to the end of 2 years follow-up
Time-to-next-treatment
Time to treatment switch
Measured: From index date to the end of 2 years follow-up
Hospitalization
Emergency room visit or hospitalization lasting more than 3 days
Measured: From index date to the end of 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, Pusan National University Hospital, Catholic Medical Center of Korea
- Responsible party
- Principal investigator, Jung Mi Oh, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751108
- Sponsor's protocol ID
- E-2024-4237
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational study using a common data model as the data source, where raw data at the individual patient level cannot be exported or managed externally.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Concomitant Use of Steroids and Immune-Checkpoint Inhibitors on Survival Outcomes in NSCLC Patients: a Multicenter Target Trial Emulation Study Utilizing EHR-based Common Data Models
- ClinicalTrials.gov ID
- NCT06751108
- Acronym / sponsor ID
- E-2024-4237
- Conditions
- NSCLC, Non Small Cell Lung Cancer
- Keywords
- NSCLC, Non small cell lung cancer, ICI, Immune check point inhibitor, corticosteroid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, Pusan National University Hospital, Catholic Medical Center of Korea
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
The goal of this observational study is to assess the effects of systemic corticosteroid use during immune checkpoint inhibitor (ICI) therapy in patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is:
Does the use of systemic corticosteroids during the initial continuous administration of ICI therapy affect overall survival (OS) and treatment outcomes in NSCLC patients?
Participants who received ICI therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab) between December 31, 2014, and December 31, 2021, as part of their routine medical care, will be included. Patient data will be analyzed retrospectively using clinical data from five institutions, and a 1:1 propensity score matching method will be employed to balance the baseline characteristics between groups. Statistical analyses will focus on overall survival, time-to-next-treatment (TNT), and metastasis-free survival (MFS).
Detailed description
Purposive sampling was employed to select participants who met the specific inclusion criteria, focusing on patients diagnosed with non-small cell lung cancer (NSCLC) and treated with immune checkpoint inhibitors (ICI) (nivolumab, pembrolizumab, atezolizumab, or durvalumab) during routine clinical practice. The study specifically targets patients who received their first ICI therapy between December 31, 2014, and December 31, 2021. Participants are restricted to those diagnosed with NSCLC within 2 years prior to the date of first ICI administration. Patients with documented pregnancy within 180 days prior to the enrollment date were excluded, as were those under 18 years of age or over 100 years of age at the time of enrollment. Individuals with a history of any primary malignancy other than lung cancer within 2 years prior to the enrollment date and those who received concomitant anticancer therapies such as taxane, platinum, pemetrexed, etoposide, doxorubicin, gemcitabine, irinotecan, vinorelbine, vinblastine, or bevacizumab at the index date were also excluded. All participants were identified retrospectively from clinical data models (CDM) or electronic medical records (EMRs) across five institutions: Seoul National University Hospital, Bundang Seoul National University Hospital, Pusan National University Hospital, and the Catholic Medical Center of Korea. To minimize selection bias inherent to observational studies, time-dependent propensity score matching was performed, simulating pseudo-randomization to balance baseline characteristics between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid Concomitant Group | – | Drug: Corticosteroids (CS), Drug: Immune Checkpoint InhibitorsPatients who received systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors. |
| Steroid Non-Concomitant Group | – | Drug: Immune Checkpoint InhibitorsPatients who did not receive systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be established by constructing cohorts from patients treated at the following four hospitals: Seoul National University Hospital, Bundang Seoul National University Hospital, Pusan National University Hospital, and the Seoul Catholic Medical Center of Korea.
Key inclusion criteria (2 listed)
- Patients who received immune checkpoint inhibitor (ICI) therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab) for the first time between December 31, 2014 and December 31, 2021.
- Patients diagnosed with non-small cell lung cancer (NSCLC) within 2 years prior to the date of first ICI administration.
Key exclusion criteria (4 listed)
- Patients with documented pregnancy within 180 days prior to the enrollment date.
- Patients who were under 18 years of age or over 100 years of age at the time of enrollment.
- Patients with a history of any primary malignancy other than lung cancer within 2 years prior to the enrollment date.
- Patients who received concomitant anticancer therapies (taxane, platinum, pemetrexed, etoposide, doxorubicin, gemcitabine, irinotecan, vinorelbine, vinblastine, or bevacizumab) at the index date.
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 |
|---|---|---|
| Corticosteroids (CS)Concomitant use of immune checkpoint inhibitors and corticosteroids | Drug | Steroid Concomitant Group |
| Immune Checkpoint InhibitorsNon-concomitant use of corticosteroids | Drug | Steroid Concomitant Group, Steroid Non-Concomitant Group |
Primary outcome
Overall survival
Time frame: From index date to the end of 2 years follow-up
3 secondary outcomes
Metastasis-free survival
Time frame: From index date to the end of 2 years follow-up
Time-to-next-treatment
Time frame: From index date to the end of 2 years follow-up
Hospitalization
Time frame: From index date to the end of 2 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. This is an observational study using a common data model as the data source, where raw data at the individual patient level cannot be exported or managed externally.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, Non Small Cell Lung Cancer, run by Seoul National University at 1 site in South Korea.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: From index date to the end of 2 years follow-up). 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 27 Dec 2024.