Could a prostate cancer drug help fight lung cancer?
NCT ID NCT06512207
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether adding a hormone therapy (leuprorelin) to an immunotherapy (sintilimab) can help older men with advanced lung cancer. The idea is that lowering sex hormones may rejuvenate the immune system, making the immunotherapy more effective. Eighty men aged 60 and older with stage III or IV non-small cell lung cancer will receive both drugs, and researchers will track tumor shrinkage and immune cell changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- leuprorelin acetate (hormone therapy) and sintilimab (immunotherapy)
- What this could lead to
- If it works, this combination could offer a new treatment option for advanced lung cancer in older men, potentially improving tumor shrinkage and disease control.
- What could go wrong
- This is an early-stage trial with only 80 participants, all older men, so results may not apply to others. The combination may cause side effects like fatigue, hormone-related issues, or immune reactions, and may not improve outcomes.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jun 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.
- Ages
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60 years and older
- Sex
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Male participants only
- 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.
Show the full entry requirements Hide 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.
3.Inclusion Criteria: 1. Male patients aged ≥60 years. 2. ECOG performance status score of 0 \~1. 3. Expected survival time of more than 3 months. 4. Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC. 5. Patients who have not previously received any anti-PD-1 treatment. 6. Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria. 7. At least one tumor lesion meeting the following criteria: * No prior local treatments such as radiotherapy * Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy). * Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm). * If only one measurable lesion, no prior local treatments such as radiotherapy. 8. Ability to understand and voluntarily sign a written informed consent form. 9. Willingness to follow the study protocol and follow-up examinations. Exclusion Criteria: * Exclusion of cases that do not meet the inclusion criteria
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450052, China
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Other studies related to the condition(s) this trial covers.
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- Aiming to spare lung cancer patients from chemo: a smarter Pre-Surgery plan?
- Can a smart drug deliver a toxic payload directly to cancer cells?
- New support model aims to ease burden on caregivers of older lung cancer patients
- Breath of discovery: simple test may sniff out lung cancer