NCT06751108Active, not recruiting
Impact of Concomitant Use of Steroids and Immune-Checkpoint Inhibitors on Survival Outcomes in NSCLC Patients
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
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Seoul National University
- Diseases
- Lung cancer
- NCT number
- NCT06751108
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Nov 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with documented pregnancy within 180 days prior to the enrollment date.
- 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.
Age
- Patients who were under 18 years of age or over 100 years of age at the time of enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.