CompletedNot Applicable

Sarcopenia and CRP-TyG Index (CTI) as Predictors of Immunotherapy Response in Metastatic Non-Small Cell Lung Cancer

Turkey (Türkiye)131 participantsStarted 2022-11-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age ≥18 years. * Histologically confirmed diagnosis of metastatic non-small cell lung cancer (mNSCLC). * Received at least one cycle of immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) as part of routine clinical care. * Availability of baseline CT imaging (within 4 weeks before treatment initiation) and follow-up CT imaging at approximately 3 months. * Availability of baseline laboratory data including C-reactive protein (CRP), triglycerides, and fasting glucose. * Adequate clinical records for evaluation of treatment response and survival outcomes. Exclusion Criteria: * Age \<18 years. * Patients without immunotherapy treatment. * Incomplete or missing CT imaging or laboratory data required for sarcopenia or CTI assessment. * Patients lost to follow-up before first radiological evaluation. * Prior malignancy within 5 years (except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).

What they're measuring

Objective Response Rate (ORR)

Timeframe: Baseline to 12 months after initiation of immunotherapy

Trial details

NCT IDNCT07192926

SponsorAnkara Etlik City Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-12-15