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Metastatic Non-small Cell Lung CancerSARC-CTINCT07192926

Body Composition and Inflammatory-Metabolic Indices in Immunotherapy-Treated Metastatic Non-Small Cell Lung Cancer: The SARC-CTI Study

An observational study of Metastatic Non-small Cell Lung Cancer and Neoplasm, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This retrospective, single-center observational cohort study evaluates inflammatory-metabolic, cachexia-related, and computed tomography (CT)-derived body-composition markers in patients with metastatic non-small cell lung cancer (mNSCLC) treated with immune checkpoint inhibitor (ICI)-based therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Immune Checkpoint Inhibitor-Based Therapy
How many people
155 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Dec 2022to 11 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population comprised 155 consecutive 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 patients included in the overall cohort had available baseline clinical and laboratory data required for calculation of the C-reactive protein-triglyceride glucose index (CTI) and cachexia index (CXI), together with an eligible abdominal computed tomography (CT) examination obtained within 30 days before ICI initiation and suitable for L3-level body-composition assessment. Longitudinal body-composition analyses were performed in a landmark cohort of 140 patients who also had an eligible early follow-up CT performed 8-12 weeks after ICI initiation and were alive and evaluable at the landmark assessment.

Who may be able to join

  • Age ≥18 years.
  • Histologically confirmed metastatic non-small cell lung cancer.
  • Receipt of at least one dose of ICI-based systemic therapy as part of routine clinical care.
  • Eligible baseline abdominal CT obtained within 30 days before ICI initiation and suitable for L3-level body-composition analysis.
  • Availability of baseline clinical and laboratory data required for CTI and CXI calculation.
  • Availability of body-weight/cachexia-related information and survival follow-up.
  • Additional criterion for the landmark longitudinal analyses
  • Eligible early follow-up CT performed approximately 8-12 weeks after ICI initiation and availability for landmark assessment.

Who cannot join

  • No eligible baseline abdominal CT or inadequate image quality for L3 segmentation.
  • Missing laboratory data required for CTI or CXI calculation.
  • Missing relevant body-weight/cachexia data.
  • Incomplete survival follow-up.
  • Absence of a usable L3 level or other clinical/imaging circumstances precluding reliable body-composition assessment.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Etlik City Hospital Medical Oncology Department

    Ankara, Yenimahalle, 06270

  • Etlik City Hospital Radiology Department

    Ankara, Yenimahalle, 06270

Other trials in Turkey (Türkiye)

About this study

Official title: Body Composition and Inflammatory-Metabolic Indices as Prognostic Markers in Immunotherapy-Treated Metastatic Non-Small Cell Lung Cancer: The SARC-CTI Study

This retrospective, single-center observational cohort study evaluates inflammatory-metabolic, cachexia-related, and computed tomography (CT)-derived body-composition markers in patients with metastatic non-small cell lung cancer (mNSCLC) treated with immune checkpoint inhibitor (ICI)-based therapy.

The study includes 155 consecutive adult patients who initiated ICI-based therapy at Ankara Etlik City Hospital between December 2022 and March 2025. Baseline assessments include the C-reactive protein-triglyceride glucose index (CTI), cachexia index (CXI), CT-derived skeletal muscle index (SMI), skeletal muscle attenuation, sarcopenia status, body weight, and clinical characteristics.

Read more

The principal survival outcomes are progression-free survival (PFS) and overall survival (OS). Associations of baseline CTI and CXI with PFS and OS are evaluated using Cox proportional hazards regression models. The incremental prognostic performance of CTI and CXI beyond conventional clinical factors is further explored using discrimination, calibration, and decision-curve analyses.

Early longitudinal changes in CT-derived body composition and body weight are evaluated in a landmark cohort of 140 patients with an eligible follow-up CT performed 8-12 weeks after ICI initiation. Associations of early skeletal muscle and body-weight changes with subsequent PFS and OS are assessed using landmark survival analyses.

The survival data cutoff is June 11, 2026.

Read the detailed description

Immune checkpoint inhibitors (ICIs) have improved outcomes in metastatic non-small cell lung cancer (mNSCLC), but substantial heterogeneity in clinical outcomes remains. Host-related factors reflecting systemic inflammation, metabolic status, nutritional reserve, and skeletal muscle composition may provide prognostic information beyond conventional tumor- and treatment-related characteristics.

This retrospective, single-center observational cohort study includes consecutive adult patients with histologically confirmed mNSCLC who initiated ICI-based systemic therapy at Ankara Etlik City Hospital between December 2022 and March 2025. A total of 155 patients meeting the eligibility criteria constitute the overall cohort. The survival data cutoff is June 11, 2026.

Baseline CT-derived body composition is assessed at the third lumbar vertebral level using an eligible abdominal CT examination performed within 30 days before ICI initiation. Skeletal muscle area (SMA), skeletal muscle index (SMI), and skeletal muscle attenuation are evaluated using a standardized segmentation protocol. SMI is calculated as skeletal muscle area divided by height squared (cm²/m²). Sarcopenia is defined using sex-specific L3 SMI thresholds of <52.4 cm²/m² for men and <38.5 cm²/m² for women.

Two composite baseline indices are evaluated. The C-reactive protein-triglyceride glucose index (CTI) is calculated as:

TyG = ln[(fasting triglyceride [mg/dL] × fasting glucose [mg/dL]) / 2]

CTI = 0.412 × ln[CRP (mg/L)] + TyG.

The cachexia index (CXI) is calculated as:

CXI = (SMI × serum albumin [g/dL]) / neutrophil-to-lymphocyte ratio.

CTI and CXI are analyzed as continuous variables and are evaluated in separate multivariable models because they capture partly overlapping inflammatory, metabolic, nutritional, and body-composition domains.

The principal survival outcomes are progression-free survival (PFS) and overall survival (OS), calculated from ICI initiation. Associations of baseline CTI and CXI with PFS and OS are evaluated using multivariable Cox proportional hazards regression models incorporating prespecified clinically relevant covariates. Model performance is explored using Harrell's concordance index and time-dependent receiver operating characteristic analyses for 12-month OS and 6-month PFS. Calibration and decision-curve analyses are also performed. These analyses describe apparent performance within the study cohort and are not externally validated.

Early longitudinal changes in body composition are evaluated in a landmark cohort of 140 patients who have both an eligible baseline CT and an early follow-up CT performed 8-12 weeks after ICI initiation and who are evaluable at the landmark assessment. Changes in SMI, skeletal muscle attenuation, sarcopenia status, and body weight are assessed. Landmark PFS and OS are calculated from the date of the early follow-up CT to reduce immortal-time bias.

Radiologic response at the first response assessment is additionally described using RECIST version 1.1 whenever adequate measurable disease and anatomic imaging are available. Sensitivity analyses are performed in patients treated with ICI monotherapy, and exploratory analyses assess relationships among CTI, CXI, sarcopenia, body composition, and other clinical characteristics.

The study is observational and retrospective; all treatments were administered as part of routine clinical care, and no study-specific therapeutic intervention was performed.

Being tested
Immune Checkpoint Inhibitor-Based Therapy
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)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Sarcopenia, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immune Checkpoint Inhibitor-Based TherapyDrug

    Also called Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab

    Retrospective observation of patients who received standard-of-care ICI-based systemic therapy, including PD-1/PD-L1 inhibitor monotherapy, PD-1/PD-L1 inhibitor plus chemotherapy, or PD-1 plus CTLA-4 inhibitor-based combination therapy with chemotherapy. The PD-1/PD-L1 inhibitors used were nivolumab, pembrolizumab, and atezolizumab. No experimental treatment was administered as part of this observational study.

Study groups in NCT07192926
Study groupRoleWhat they receive
Metastatic NSCLC Patients Treated With ICI-Based TherapyThis cohort includes 155 adult patients with histologically confirmed metastatic non-small cell lung cancer who initiated immune checkpoint inhibitor-based systemic therapy at Ankara Etlik City Hospital between December 2022 and March 2025 and met the predefined eligibility criteria for baseline prognostic analyses. All patients had the clinical and laboratory data required for CTI and CXI calculation and an eligible baseline abdominal CT suitable for L3-level body-composition assessment. Early longitudinal body-composition analyses were performed in a landmark subset of 140 patients with an eligible follow-up CT obtained 8-12 weeks after ICI initiation.
Receives: Drug: Immune Checkpoint Inhibitor-Based Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Time from initiation of immune checkpoint inhibitor (ICI)-based therapy to radiologic or clinical disease progression or death from any cause, whichever occurred first. Progression-free survival (PFS) is evaluated in relation to baseline C-reactive protein-triglyceride glucose index (CTI), cachexia index (CXI), and prespecified clinical covariates.

    Measured: From ICI initiation through the survival data cutoff of June 11, 2026.

  2. Overall Survival (OS)

    Time from initiation of immune checkpoint inhibitor (ICI)-based therapy to death from any cause. Overall survival (OS) is evaluated in relation to baseline C-reactive protein-triglyceride glucose index (CTI), cachexia index (CXI), and prespecified clinical covariates.

    Measured: From ICI initiation through the survival data cutoff of June 11, 2026.

Secondary outcomes (6)
  1. Early Change in Skeletal Muscle Index (SMI)

    Percentage change in computed tomography (CT)-derived skeletal muscle index (SMI) measured at the third lumbar vertebral (L3) level between baseline and the early follow-up CT assessment. Skeletal muscle index is calculated as skeletal muscle area divided by height squared (cm²/m²). Early SMI change is evaluated both continuously and according to skeletal muscle loss of at least 5%.

    Measured: Baseline to early follow-up assessment, approximately 8-12 weeks after initiation of ICI-based therapy.

  2. Early Change in Skeletal Muscle Attenuation

    Absolute change in mean computed tomography (CT)-derived skeletal muscle attenuation, expressed in Hounsfield units (HU), between baseline and the early follow-up CT assessment at the third lumbar vertebral (L3) level.

    Measured: Baseline to early follow-up assessment, approximately 8-12 weeks after initiation of ICI-based therapy.

  3. Early Change in Body Weight

    Percentage change in body weight between initiation of immune checkpoint inhibitor (ICI)-based therapy and the early follow-up assessment. Body-weight change is evaluated continuously and according to body-weight loss of at least 5%.

    Measured: Baseline to early follow-up assessment, approximately 8-12 weeks after initiation of ICI-based therapy.

  4. Sarcopenia Transition Status

    Change in computed tomography (CT)-defined sarcopenia status between baseline and the early follow-up assessment. Patients are categorized as persistently non-sarcopenic, incident sarcopenia, resolved sarcopenia, or persistently sarcopenic according to sex-specific third lumbar vertebral (L3) skeletal muscle index (SMI) thresholds.

    Measured: Baseline to early follow-up assessment, approximately 8-12 weeks after initiation of ICI-based therapy.

  5. Objective Response Rate (ORR)

    Proportion of patients achieving complete response (CR) or partial response (PR) at the first response assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), whenever measurable disease and adequate anatomic imaging are available. Patients with clinical or radiologic progression or death before the first scheduled response assessment are considered nonresponders.

    Measured: At the first response assessment, approximately 8-12 weeks after initiation of ICI-based therapy.

  6. Disease Control Rate (DCR)

    Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at the first response assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), whenever measurable disease and adequate anatomic imaging are available. Patients with clinical or radiologic progression or death before the first scheduled response assessment are classified as not achieving disease control.

    Measured: At the first response assessment, approximately 8-12 weeks after initiation of ICI-based therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start1 Dec 2022
  3. Primary completion30 Mar 2025
  4. Study completion11 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192926
Sponsor's protocol ID
AEŞH-BADEK2-2025-452
Other IDs
AEŞH-BADEK2-2025-452
Acronym
SARC-CTI
Status last verified
Sep 2025
First submitted
18 Sep 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Non-small Cell Lung Cancer and Neoplasm, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From ICI initiation through the survival data cutoff of June 11, 2026.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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