Clinical trial · Observational
Body Composition and Blood-Based Prognostic Markers in Immunotherapy-Treated Metastatic Non-Small Cell Lung Cancer
Body Composition and Inflammatory-Metabolic Indices as Predictors of Immunotherapy Outcomes in Metastatic Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic NSCLC Patients Treated With Immunotherapy
- description
- 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).
- interventionNames
- Drug: Immune Checkpoint Inhibitors
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Baseline to 12 months after initiation of immunotherapy
- description
- Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, based on radiological evaluation.
Secondary outcomes (6)
- measure
- Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available