Large granular lymphocytes in metastatic non-small cell lung cancer treated with nivolumab
Large Granular Lymphocytes as a Prognostic Factor in Metastatic Non-small Cell Lung Cancer Treated With Nivolumab
This study will test whether the percentage of large granular lymphocytes in the blood at baseline and after three months can predict response to nivolumab in people with metastatic non-small cell lung cancer receiving it as second-line therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Necmettin Erbakan University Academic / other |
| Drugs / interventions | nivolumab, Pembrolizumab, chemotherapy, Immunotherapy |
| Locations | 1 site (Konya, Meram) |
| Trial ID | NCT07363811 on ClinicalTrials.gov |
What this trial studies
This is an observational study measuring large granular lymphocytes (LGLs) by peripheral blood smear in patients with metastatic non-small cell lung cancer treated with nivolumab as second-line therapy. LGL percentage will be recorded at baseline and at three months and correlated with treatment response and clinical parameters. Eligible participants have histologically confirmed metastatic NSCLC, ECOG 0–2, and no recent steroids, active infections, hematologic malignancies, or recent radiotherapy. The study aims to identify whether LGL levels are a simple blood-based marker associated with outcomes on PD-1 blockade.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic NSCLC who are starting nivolumab as second-line therapy with ECOG performance status 0–2 and no recent steroid use, active infections, hematologic malignancy, or recent radiotherapy.
Not a fit: Patients who received nivolumab as adjuvant/perioperative therapy, those with concurrent hematologic malignancies, recent palliative or curative radiotherapy, active infections, or recent steroid use are unlikely to be eligible or to benefit from the study findings.
Why it matters
Potential benefit: If successful, this could help doctors predict which patients are more likely to benefit from nivolumab and guide treatment decisions.
How similar studies have performed: Previous research has linked various immune cell subsets to outcomes with PD-1 inhibitors, but using peripheral blood LGL percentage specifically is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological and staging diagnosis of metastatic non-small cell lung cancer * ECOG performance score between 0 and 2 * No contraindications for nivolumab Exclusion Criteria: * Patients diagnosed with mNSCLC who received nivolumab as adjuvant or perioperative therapy * Those with a second primary malignancy undergoing active treatment * Those who have not signed the informed consent form * Those with additional hematological malignancies such as leukemia, lymphoma, or myelodysplastic syndrome * Those who have undergone palliative or curative radiotherapy within the last three months * Those with active viral/bacterial infections before nivolumab treatment * Patients who have used steroids in the last three months
Where this trial is running
Konya, Meram
- Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology — Konya, Meram, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ahmet Oruç MD
- Email: mdahmetoruc@gmail.com
- Phone: +90 0505 704 50 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.