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Could a simple cortisol test predict immunotherapy outcomes?

NCT ID NCT07530276

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 330 people with non-small cell lung cancer who receive immunotherapy before surgery. Researchers measure cortisol levels at different times to see if changes in this stress hormone relate to how well the tumor shrinks or if side effects occur. The goal is to find a simple blood marker that might help guide treatment decisions in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors use cortisol levels as a simple blood test to predict how well immunotherapy works in lung cancer patients.
What could go wrong
This is an observational study, not a treatment trial. It only looks for patterns, so it won't directly improve patient care. Results may not lead to any practical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Guangzhou, Guangdong, 510000, China

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