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NCT07192926

Body Composition and Blood-Based Prognostic Markers in Immunotherapy-Treated Metastatic Non-Small Cell Lung Cancer

Sponsor: Ankara Etlik City Hospital

View on ClinicalTrials.gov

Summary

This study investigates the impact of sarcopenia and the CRP-TyG Index (CTI) on immunotherapy outcomes in patients with metastatic non-small cell lung cancer (NSCLC). Medical records of 115 adult patients treated with immune checkpoint inhibitors at Ankara Etlik City Hospital between November 2022 and December 2024 will be retrospectively analyzed. Sarcopenia will be determined from CT-based skeletal muscle index (SMI) measurements at the L3 vertebral level. SMI will be calculated as skeletal muscle area (cm²) divided by height squared (m²), with sex-specific cut-offs (≤52.4 cm²/m² for men, ≤38.5 cm²/m² for women). CTI will be calculated from CRP, triglycerides, and fasting glucose values. Primary outcome is objective response rate (ORR, RECIST 1.1). Secondary outcomes include 1-year progression-free survival (PFS), 1-year overall survival (OS), treatment duration, and adverse events (CTCAE v5.0).

Official title: Body Composition and Inflammatory-Metabolic Indices as Predictors of Immunotherapy Outcomes in Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

155

Start Date

2022-12-01

Completion Date

2026-06-11

Last Updated

2026-07-21

Healthy Volunteers

No

Interventions

DRUG

Immune Checkpoint Inhibitors

Retrospective analysis of patients with metastatic non-small cell lung cancer (mNSCLC) who received standard-of-care immune checkpoint inhibitors, including PD-1 and PD-L1 inhibitors (e.g., nivolumab, pembrolizumab, atezolizumab, durvalumab). Patients received these agents as part of routine clinical practice; no experimental intervention was administered in this study.

Locations (2)

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, Turkey (Türkiye)

Etlik City Hospital Radiology Department

Ankara, Yenimahalle, Turkey (Türkiye)