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

NCT ID: NCT06751108

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-06-30

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.

Conditions

NSCLC, Non Small Cell Lung Cancer

Keywords

NSCLC; Non small cell lung cancer; ICI; Immune check point inhibitor; corticosteroid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Steroid Concomitant Group

Patients who received systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.

Corticosteroids (CS)

Intervention Type: DRUG

Concomitant use of immune checkpoint inhibitors and corticosteroids

Immune Checkpoint Inhibitors

Intervention Type: DRUG

Non-concomitant use of corticosteroids

Steroid Non-Concomitant Group

Patients who did not receive systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.

Immune Checkpoint Inhibitors

Intervention Type: DRUG

Non-concomitant use of corticosteroids

Interventions

Corticosteroids (CS)

Concomitant use of immune checkpoint inhibitors and corticosteroids

Intervention Type: DRUG

Immune Checkpoint Inhibitors

Non-concomitant use of corticosteroids

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Pusan National University Hospital

OTHER

Sponsor Role: collaborator

Catholic Medical Center of Korea

UNKNOWN

Sponsor Role: collaborator

Seoul National University

OTHER

Sponsor Role: lead

Responsible Party

Jung Mi Oh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

E-2024-4237

Identifier Type: -

Identifier Source: org_study_id