Could a simple cortisol test predict immunotherapy outcomes?
NCT ID NCT07530276
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
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510000
Guangzhou, Guangdong, 510000, China
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