Brief Summary

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.

Conditions

• Metastatic NSCLC - Non-Small Cell Lung Cancer

Primary Outcome Measures

• Objective response rate according to RECIST 1.1 Evaluation of target lesions (From enrollment to the end of treatment at 12 weeks)
  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.

Countries

Turkey (Türkiye)

Locations and Investigators

• Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology, Konya, Turkey (Türkiye) (Recruiting)
  • Mehmet Artaç, MD

Study Officials

• Mehmet Artaç (Study Director) — Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology