Large Granular Lymphocytes in mNSCLC Treated With Nivolumab
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorNecmettin Erbakan University
About this trial
Large granular lymphocytes (LGLs), which constitute 10-15% of peripheral blood mononuclear cells, are large lymphocytes with a round nucleus, large cytoplasm, and azurophilic granules in the cytoplasm.
Most normal LGLs in peripheral blood are natural killer (NK) cells, but some are T lymphocytes. These cells cannot be measured by a standard complete blood count (CBC) test. These cells, which can be detected by peripheral smear, are expressed numerically and as a percentage relative to other cells. The aim of this study is to determine the relationship between the percentage of LGLs at baseline and at three months and the response and clinical parameters in participants with metastatic non-small cell lung cancer treated with nivolumab in second-line therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological and staging diagnosis of metastatic non-small cell lung cancer
ECOG performance score between 0 and 2
No contraindications for nivolumab
Disqualifiers
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
Trial population
Patients diagnosed with metastatic non-small cell lung cancer who were followed up at the Medical Oncology Clinic of Necmettin Erbakan University Hospital and treated with nivolumab as second-line therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Objective response rate according to RECIST 1.1 Evaluation of target lesions
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Progression-free survival
It was defined as the time from the initiation of nivolumab treatment until disease progression or death, whichever occurred first. For patients without progression, PFS was calculated from the date of data entry onwards.
Time frame
From July 2025 to July 20272
Overall survival
It was defined as the time from the start of nivolumab treatment until death from any cause, or until the last follow-up date for patients still alive.
Time frame
From July 2025 to July 2027Sponsors and contacts
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Source ClinicalTrials.gov