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

NCT07192926 | Completed

• 1 other identifier: AEŞH-BADEK2-2025-452
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Metastatic Non-small Cell Lung Cancer; Neoplasm

Keywords

sarcopenia; CTI Score; Immunotherapy; Immune Checkpoint Inhibitors; PD-1 / PD-L1 Inhibitors; Prognostic Biomarker; Survival Outcomes; Skeletal Muscle Index (SMI); CRP-TyG Index (CTI)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, based on radiological evaluation.

  Baseline to 12 months after initiation of immunotherapy

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  Baseline to 12 months

• Overall Survival (OS)

  Baseline to 12 months

• Treatment Duration

  Baseline to end of treatment (up to 12 months)

• Adverse Events (Toxicity Profile)

  Baseline to 12 months

• Sarcopenia Status at Baseline

  At baseline (0 months)

Other Outcomes (3)

• Change in Sarcopenia (ΔSMI)

  Baseline to 3 months

• CRP-TyG Index (CTI) Prognostic Value

  At baseline (0 months)

• Correlation Between Sarcopenia and CTI

  Baseline to 12 months

Study Arms (1)

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).

Drug: Immune Checkpoint Inhibitors

Interventions

Immune Checkpoint Inhibitors 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.

Also known as: Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab

Metastatic NSCLC Patients Treated With Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprised 155 adult patients with histologically confirmed metastatic non-small cell lung cancer (mNSCLC) who initiated immune checkpoint inhibitor (ICI)-based therapy at Ankara Etlik City Hospital between December 2022 and March 2025. All included patients had available baseline clinical and laboratory data, including the variables required to calculate the C-reactive protein-triglyceride glucose index (CTI) and cachexia index (CXI), as well as an eligible abdominal computed tomography scan obtained within 30 days before ICI initiation for L3-level body composition assessment. Longitudinal body composition analyses were conducted in a landmark cohort of 140 patients who also underwent an early follow-up CT assessment 8-12 weeks after ICI initiation and were alive and progression-assessable at the landmark time point.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (2)

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, 06270, Turkey (Türkiye)

Location

Etlik City Hospital Radiology Department

Ankara, Yenimahalle, 06270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Sarcopenia; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Immune Checkpoint Inhibitors; Nivolumab; pembrolizumab; atezolizumab; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Galip Can Uyar, MD

  Etlik City Hospital Medical Oncology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 25, 2025
• Study Start: December 1, 2022
• Primary Completion: March 30, 2025
• Study Completion: June 11, 2026
• Last Updated: July 21, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)