Clinical Trial

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

Study acronym: SARC-CTI
Completed
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-09-18; most recent amendment 2026-07-18.
Status change: Active, Not Recruiting → Completed 2026-02-19
Trial Details
NCT Number NCT07192926
Lead Sponsor Ankara Etlik City Hospital
Conditions Metastatic Non-small Cell Lung Cancer, Neoplasm
Enrollment 155 participants
Start Date 2022-12-01
Primary Completion 2025-03-30 (estimated)
Study Completion 2026-06-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-21