Seoul National University
Seoul, South Korea
NCT Number: NCT06751108
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).
This study is active but is not currently recruiting participants.
Notify Me18 year–100 year
All sexes
Observational
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Concomitant use of immune checkpoint inhibitors and corticosteroids
Non-concomitant use of corticosteroids
Time frame: From index date to the end of 2 years follow-up
Time frame: From index date to the end of 2 years follow-up
Duration of survival without distant metastasis
Time frame: From index date to the end of 2 years follow-up
Time to treatment switch
Time frame: From index date to the end of 2 years follow-up
Emergency room visit or hospitalization lasting more than 3 days
Seoul National University
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07003490
Bronchial Neoplasms, Carcinoma, Bronchogenic
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05973773
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation, Bronchial Neoplasms
Henderson, Nevada, United States
View Trial DetailsNCT06710132
Bronchial Neoplasms, Carcinoma, Bronchogenic
Santa Monica, California, United States
View Trial DetailsNCT04606771
Bronchial Neoplasms, Carcinoma
Duarte, California, United States
View Trial Details