Large Granular Lymphocytes in mNSCLC Treated With Nivolumab

NCT07363811 | Recruiting

• 1 other identifier: 26105/2025/5927
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Large granular lymphocyte; Nivolumab

Outcome Measures

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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

• Progression-free survival

  From July 2025 to July 2027

• Overall survival

  From July 2025 to July 2027

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Histological and staging diagnosis of metastatic non-small cell lung cancer
• ECOG performance score between 0 and 2
• No contraindications for nivolumab

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology

Konya, Meram, 42090, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Conroy MR, O'Sullivan H, Collins DC, Bambury RM, Power D, Grossman S, O'Reilly S. Exploring the prognostic impact of absolute lymphocyte count in patients treated with immune-checkpoint inhibitors. BJC Rep. 2024 Apr 18;2(1):31. doi: 10.1038/s44276-024-00058-6.

  PMID: 39516713 RESULT

• Oshimi K. Clinical Features, Pathogenesis, and Treatment of Large Granular Lymphocyte Leukemias. Intern Med. 2017;56(14):1759-1769. doi: 10.2169/internalmedicine.56.8881. Epub 2017 Jul 15.

  PMID: 28717070 RESULT

• Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.

  PMID: 30955977 RESULT

• Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15.

  PMID: 33449799 RESULT

• Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.

  PMID: 27718847 RESULT

• Assi HI, Kamphorst AO, Moukalled NM, Ramalingam SS. Immune checkpoint inhibitors in advanced non-small cell lung cancer. Cancer. 2018 Jan 15;124(2):248-261. doi: 10.1002/cncr.31105. Epub 2017 Dec 6.

  PMID: 29211297 RESULT

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected immediately before starting nivolumab treatment and at the third month, and peripheral blood smears will be performed. Two hematology specialists will provide the percentage (%) of LGL cells. The specialists will be blinded to patient information and will not be able to see each other's results. Subsequently, the average of the results provided by the two specialists for each patient will be calculated.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mehmet Artaç

  Necmettin Erbakan University Faculty of Medicine, Department of Medical Oncology

  STUDY DIRECTOR

Central Study Contacts

Ahmet Oruç MD

CONTACT

+90 0505 704 50 20; mdahmetoruc@gmail.com

Mehmet Artaç MD

CONTACT

+90 532 267 98 38; mehmetartac@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology Clinic, Prof. Dr.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

TU (1)