A Prospective Observational Study of Changes in Cortisol Levels After Neoadjuvant Immunotherapy and Their Prognostic Value in Patients With NSCLC

April 8, 2026 updated by: Guangdong Provincial People's Hospital
This study is an open, prospective and observational clinical trial. Adopting a prospective cohort study design, it selects patients with non-small cell lung cancer who receive neoadjuvant immunotherapy as the research subjects. Through systematic follow-up, it monitors the dynamic changes of cortisol levels of patients at different treatment stages and after surgery, and analyzes the associations between these changes and disease progression, treatment effect and adverse reactions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a single-center prospective observational cohort study. No experimental intervention will be performed on the participants, all clinical treatments and examinations are fully in accordance with the routine clinical diagnosis and treatment specifications for resectable non-small cell lung cancer. We only prospectively collect the clinical data and laboratory test results of the participants to analyze the correlation between perioperative dynamic changes of cortisol and the outcomes of neoadjuvant immunochemotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a single-center prospective observational cohort study. The study population includes adult patients aged 18-75 years with histologically confirmed resectable stage ⅡA-ⅢB non-small cell lung cancer (NSCLC), who receive standard neoadjuvant PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy followed by radical surgery in our center.

Description

Inclusion Criteria:

  1. Histologically confirmed primary non-small cell lung cancer (NSCLC), with clinical stage ⅡA-ⅢB resectable/potentially resectable disease, assessed according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system.
  2. Aged 18 to 75 years old, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Planned to receive standard neoadjuvant PD-1/PD-L1 immune checkpoint inhibitor combined with platinum-based doublet chemotherapy, followed by radical surgical resection.
  4. Have complete clinical data, and can complete the scheduled perioperative blood tests (including serum cortisol and ACTH level detection) and follow-up visits according to the study protocol.
  5. Voluntarily participate in this study, sign the written informed consent form, and are willing to cooperate with the research team to complete the study-related examinations and follow-up.

Exclusion Criteria:

  1. Patients with confirmed pituitary or adrenal diseases, or abnormal baseline serum cortisol/ACTH levels outside the normal reference range before enrollment.
  2. Patients with a history of long-term systemic glucocorticoid use within 3 months before enrollment, or perioperative glucocorticoid use before the postoperative cortisol test.
  3. Patients with a history of other primary malignant tumors within 5 years before enrollment (except for cured basal cell carcinoma of the skin or cervical carcinoma in situ).
  4. Patients with severe autoimmune diseases, severe liver and kidney dysfunction, severe cardiovascular and cerebrovascular diseases, or other comorbidities that cannot tolerate neoadjuvant therapy and radical surgery.
  5. Patients who did not receive radical surgical resection after neoadjuvant therapy.
  6. Patients with incomplete clinical data, who cannot complete the scheduled blood tests or follow-up visits.
  7. Pregnant or lactating women.
  8. Patients with mental illness or other conditions that cannot comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Prospective Observational Cohort of Resectable NSCLC Patients
This cohort includes patients with pathologically confirmed resectable stage ⅡA-ⅢB non-small cell lung cancer (NSCLC) who receive standard neoadjuvant PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy followed by radical surgery. This is a purely observational cohort: no study-specific intervention will be applied, all treatments and examinations are performed in full accordance with routine clinical practice. We will prospectively collect patients' clinical data, laboratory test results (including serum cortisol and ACTH levels) and pathological outcomes, to analyze the correlation between perioperative dynamic changes of cortisol and neoadjuvant treatment efficacy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major Pathological Response (MPR) Rate
Time Frame: Within 30 days after radical surgery
Proportion of patients who achieved major pathological response, defined as viable residual tumor cells ≤10% in the resected primary tumor specimen after neoadjuvant immunochemotherapy, assessed according to IASLC standardized criteria.
Within 30 days after radical surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Perioperative Cortisol Dynamic Changes and Pathological Response
Time Frame: From baseline (within 7 days before neoadjuvant treatment initiation) to 7 days after radical surgery
The correlation between the relative change rate of serum cortisol (from baseline before neoadjuvant therapy to 1 day after surgery) and the proportion of residual viable tumor cells, as well as the achievement of MPR/pCR.
From baseline (within 7 days before neoadjuvant treatment initiation) to 7 days after radical surgery
Incidence of Immune Checkpoint Inhibitor (ICIs)-Related Adrenocortical Dysfunction
Time Frame: From neoadjuvant treatment initiation to 12 months after surgery
The cumulative incidence of ICIs-related secondary adrenocortical dysfunction, including clinical and subclinical adrenocortical insufficiency, confirmed by serum cortisol and adrenocorticotropic hormone (ACTH) test results, assessed according to the Endocrine Society Clinical Practice Guidelines.
From neoadjuvant treatment initiation to 12 months after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Immune-Related Adverse Events (irAEs)
Time Frame: From neoadjuvant treatment initiation to 12 months after surgery
The cumulative incidence of all-grade and grade ≥3 irAEs during neoadjuvant treatment and 12 months after surgery, including endocrine toxicity, pulmonary toxicity, cutaneous toxicity, etc., graded according to CTCAE version 5.0.
From neoadjuvant treatment initiation to 12 months after surgery
Disease-Free Survival (DFS)
Time Frame: From radical surgery to 36 months after surgery
The time from radical surgery to the first occurrence of tumor recurrence, distant metastasis, or all-cause death, whichever comes first.
From radical surgery to 36 months after surgery
Overall Survival (OS)
Time Frame: From neoadjuvant treatment initiation to 36 months after treatment initiation
The time from the initiation of neoadjuvant treatment to all-cause death.
From neoadjuvant treatment initiation to 36 months after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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