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Active, Not Recruiting

NCT Number: NCT06954259

Prognostic Correlation Between the Ratio of the Neutrophil Ratio to the Ratio of CD4+/CD8+ T Cells in Patients With Advanced Non-small Cell Lung Cancer NSCLC) Undergoing Immunotherapy Combined With Chemotherapy

Evaluate the prognostic correlation between the neutrophil ratio and the ratio of CD4+/CD8+ T cells in patients with advanced non-small cell lung cancer (NSCLC) who receive immunotherapy combined with chemotherapy, with the aim of providing references for clinical treatment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

About this study

According to the content released in the Global Cancer Statistics Report 2022 (Global Cancer), lung cancer is the leading cause of cancer-related deaths worldwide. Traditional treatment methods such as surgery, radiotherapy, and chemotherapy have limitations in their curative effects. Immune checkpoint inhibitors (ICIs) have greatly changed the treatment landscape of non-small cell lung cancer (NSCLC). Although progress has been made in immunotherapy, the prediction of its efficacy relies on methods such as Tumor Mutational Burden (TMB) and the expression of PD-L1. Therefore, finding more effective treatment strategies and prognostic evaluation indicators has become a key task in lung cancer research. Relevant studies have delved into the prognostic and predictive values of inflammation-related peripheral blood biomarkers in NSCLC patients receiving immunotherapy. The Neutrophil-to-lymphocyte ratio (NLR) has emerged as a potential biomarker for cancer prognosis. However, lymphocyte subsets can be influenced by factors such as race, age, medications, gender, stress, physical activity, and lifestyle. In this study, CD4+/CD8+ T cells were selected to eliminate the influence of individual differences, and it is intended to investigate whether there is a prognostic correlation of CD4+/CD8+ T cells in the immunotherapy combined with chemotherapy for patients with advanced NSCLC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1)Inoperable stage III or IV NSCLC (AJCC 8th edition TNM staging) confirmed by pathological histology or cytology.(2)Received first - line immunotherapy (PD - 1/PD - L1 inhibitors) combined with chemotherapy, and driver genes are negative.(3)There is at least one measurable lesion in the lungs on CT imaging (RECIST 1.1).(4)Have complete clinical data.(5)The patient or the authorized family member gives informed consent.

Exclusion criteria

  • (1)Have gene mutations such as EGFR/ALK/ROS1 and have not received standardized targeted therapy.(2)Have a second primary malignant tumor concurrently.(3)Have been infected or used antibiotics within 7 days before blood sampling.(4)Have severe abnormalities in the functions of organs such as the heart, liver, lungs, kidneys, and bone marrow.(5)Have other autoimmune diseases and endocrine and metabolic diseases concurrently.

Treatment and study plan

Primary outcomes

  1. Objective Remission Rate

    Time frame: Recruit patients with non-small cell lung cancer who received immunotherapy combined with chemotherapy from July 2022 to June 2024. Count the percentage of patients who achieved complete response or partial response, and the calculation deadline is April

    The objective response rate (ORR) is defined as the percentage of patients who achieve a complete response (CR) or a partial response (PR) among all the patients who have received the treatment.

  2. Progression - Free Survival

    Time frame: Recruit patients with non-small cell lung cancer who received immunotherapy combined with chemotherapy from July 2022 to June 2024. Count the duration from the initiation of immunotherapy combined with chemotherapy to the date of the first documented dis

    The Progression-Free Survival (PFS) is defined as the duration from the initiation of immunotherapy combined with chemotherapy to the date of the first documented disease progression or death.

Sponsors and collaborators

Lead sponsor

Qiang Xu

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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