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

NCT07530276 | Active Not Recruiting

• 1 other identifier: KY2025-935
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR) Rate

  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 Outcomes (2)

• Correlation Between Perioperative Cortisol Dynamic Changes and Pathological Response

  From baseline (within 7 days before neoadjuvant treatment initiation) to 7 days after radical surgery

• Incidence of Immune Checkpoint Inhibitor (ICIs)-Related Adrenocortical Dysfunction

  From neoadjuvant treatment initiation to 12 months after surgery

Other Outcomes (3)

• Incidence of Immune-Related Adverse Events (irAEs)

  From neoadjuvant treatment initiation to 12 months after surgery

• Disease-Free Survival (DFS)

  From radical surgery to 36 months after surgery

• Overall Survival (OS)

  From neoadjuvant treatment initiation to 36 months after treatment initiation

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Aged 18 to 75 years old, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Planned to receive standard neoadjuvant PD-1/PD-L1 immune checkpoint inhibitor combined with platinum-based doublet chemotherapy, followed by radical surgical resection.
• 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.
• 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.

You may not qualify if:

• Patients with confirmed pituitary or adrenal diseases, or abnormal baseline serum cortisol/ACTH levels outside the normal reference range before enrollment.
• Patients with a history of long-term systemic glucocorticoid use within 3 months before enrollment, or perioperative glucocorticoid use before the postoperative cortisol test.
• 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).
• 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.
• Patients who did not receive radical surgical resection after neoadjuvant therapy.
• Patients with incomplete clinical data, who cannot complete the scheduled blood tests or follow-up visits.
• Pregnant or lactating women.
• Patients with mental illness or other conditions that cannot comply with the study protocol.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510000

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood samples (for serum cortisol, ACTH, inflammatory biomarkers testing, and DNA extraction) and resected lung cancer pathological tissue (for MPR/pCR assessment and genomic testing)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: August 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)