NSCLC (Advanced Non-small Cell Lung Cancer)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
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Qiang Xu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced NSCLC who received immunotherapy combined with chemotherapy at Jiangxi Provincial Cancer Hospital
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Keywords
- NSCLC, lung cancer, pulmonary carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Remission Rate
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.
Measured: 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
Progression - Free Survival
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jul 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiang Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiang Xu, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954259
- Sponsor's protocol ID
- 2025ky010
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06954259
- Acronym / sponsor ID
- 2025ky010
- Keywords
- NSCLC, lung cancer, pulmonary carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Qiang XuUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced NSCLC who received immunotherapy combined with chemotherapy at Jiangxi Provincial Cancer Hospital
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Qiang Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.