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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2025-12-15

Brief Summary

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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).

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Detailed Description

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Metastatic non-small cell lung cancer (mNSCLC) is among the leading causes of cancer-related mortality worldwide. Immune checkpoint inhibitors (ICIs) targeting PD-1/PD-L1 have improved survival outcomes, yet responses remain heterogeneous. Prognostic biomarkers such as sarcopenia and systemic inflammation-metabolism indices may help optimize patient selection.

This retrospective, single-center cohort study will analyze 115 adult patients with mNSCLC treated with ICIs at Ankara Etlik City Hospital between November 2022 and December 2024. Sarcopenia will be assessed from computed tomography (CT) imaging at the L3 vertebral level by calculating skeletal muscle index (SMI = skeletal muscle area \[cm²\] / height² \[m²\]). Patients will be classified as sarcopenic if SMI ≤52.4 cm²/m² for men or ≤38.5 cm²/m² for women. Both baseline and 3-month CT scans will be analyzed to assess dynamic changes (ΔSMI).

The CRP-TyG Index (CTI) will be calculated as:

TyG = ln \[triglycerides (mg/dL) × fasting glucose (mg/dL) / 2\] CTI = 0.412 × ln \[CRP (mg/L)\] + TyG Patients will be categorized into low- and high-risk groups using the published cut-off of 4.78.

The primary endpoint is objective response rate (ORR, RECIST v1.1). Secondary endpoints include 12-month progression-free survival (PFS), overall survival (OS), treatment duration, adverse events (graded by CTCAE v5.0), and sarcopenia dynamics. Associations between CTI and sarcopenia will also be explored. Statistical analyses include multivariable logistic regression for ORR and Cox proportional hazards models for PFS/OS, adjusting for age, sex, and ECOG status.

This study aims to integrate radiological (sarcopenia), biochemical (CRP, triglycerides, glucose), and clinical outcomes to determine whether sarcopenia and CTI can serve as practical prognostic markers for immunotherapy in real-world mNSCLC patients.

Conditions

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Metastatic Non-small Cell Lung Cancer Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Metastatic NSCLC Patients Treated With Immunotherapy

This cohort includes 115 adult patients with histologically confirmed metastatic non-small cell lung cancer (mNSCLC) who received immune checkpoint inhibitors at Ankara Etlik City Hospital between November 2022 and December 2024. Patients had available baseline and 3-month CT imaging for sarcopenia assessment and laboratory data for CRP, triglycerides, and fasting glucose to calculate the CRP-TyG Index (CTI).

Immune Checkpoint Inhibitors

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nivolumab Pembrolizumab Atezolizumab Durvalumab

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No