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Could a prostate cancer drug help fight lung cancer?

NCT ID NCT06512207

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 80 people

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

Started

Dec 2023

Expected to finish

Jun 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.

Ages

60 years and older

Sex

Male participants only

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.

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

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