Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC, Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Corticosteroids (CS) | Drug | — | UNRESOLVED |
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Steroid Concomitant Group
- description
- Patients who received systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.
- interventionNames
- Drug: Corticosteroids (CS)
- Drug: Immune Checkpoint Inhibitors
- label
- Steroid Non-Concomitant Group
- description
- Patients who did not receive systemic corticosteroids concomitantly during the initial continuous administration period of immune checkpoint inhibitors.
- interventionNames
- Drug: Immune Checkpoint Inhibitors
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From index date to the end of 2 years follow-up
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
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