NCT06954259

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

April 24, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

NSCLClung cancerpulmonary carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with advanced NSCLC who received immunotherapy combined with chemotherapy at Jiangxi Provincial Cancer Hospital

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Jiangxi Provincial Cancer Hospital

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

July 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations