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

NCT06751108 | Active Not Recruiting

• 1 other identifier: E-2024-4237
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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).

Conditions

NSCLC, Non Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From index date to the end of 2 years follow-up

Secondary Outcomes (3)

• Metastasis-free survival

  From index date to the end of 2 years follow-up

• Time-to-next-treatment

  From index date to the end of 2 years follow-up

• Hospitalization

  From index date to the end of 2 years follow-up

Study Arms (2)

Steroid Concomitant Group

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

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.

Drug: Immune Checkpoint Inhibitors

Interventions

Corticosteroids (CS) DRUG

Concomitant use of immune checkpoint inhibitors and corticosteroids

Steroid Concomitant Group

Immune Checkpoint Inhibitors DRUG

Non-concomitant use of corticosteroids

Steroid Concomitant Group; Steroid Non-Concomitant Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: lead
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Pusan National University Hospital: collaborator
• Catholic Medical Center of Korea: collaborator

Study Sites (1)

Seoul National University

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Adrenal Cortex Hormones; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)