Impact of Concomitant Use of Steroids and Immune-Checkpoint Inhibitors on Survival Outcomes in NSCLC Patients

Active, not recruiting

• Conditions: NSCLC, Non Small Cell Lung Cancer
• Interventions: Drug: Corticosteroids (CS); Drug: Immune Checkpoint Inhibitors

• Registration Number: NCT06751108
• Lead Sponsor: Seoul National University

Brief 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). 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 Timeline

• Study Start: 2024-11-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Steroid Concomitant Group	Corticosteroids (CS)	Patients who received systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.
Steroid Concomitant Group	Immune Checkpoint Inhibitors	Patients who received systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.
Steroid Non-Concomitant Group	Immune Checkpoint Inhibitors	Patients who did not receive systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.

Primary Outcome Measures

Name	Time	Method
Overall survival	From index date to the end of 2 years follow-up

Secondary Outcome Measures

Name	Time	Method
Hospitalization	From index date to the end of 2 years follow-up	Emergency room visit or hospitalization lasting more than 3 days
Metastasis-free survival	From index date to the end of 2 years follow-up	Duration of survival without distant metastasis
Time-to-next-treatment	From index date to the end of 2 years follow-up	Time to treatment switch

Trial Locations

Locations (1)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of