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Timing is everything: new study seeks best sequence for brain metastases treatment

NCT ID NCT07638709

Knowledge-focused Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study looks at adults with non-small cell lung cancer that has spread to the brain. Researchers want to see if getting radiation and immunotherapy 30 days apart or closer together changes how long the brain tumors stay stable and how long patients live. Participants continue their normal treatment and allow researchers to collect health data, blood samples, and MRI scans during regular checkups.

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 150 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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

The study population comprises adult patients (aged 18 years and older) histologically or cytologically diagnosed with non-small cell lung cancer (NSCLC) accompanied by brain metastases, confirmed via contrast-enhanced head MRI. These patients are seeking treatment at Xiangya Hospital and are scheduled to receive a combination of radiotherapy and PD-1/PD-L1 immune checkpoint inhibitors according to their routine, real-world clinical care plans. The cohort specifically represents a real-world NSCLC population with relatively good performance status (ECOG 0-2), intact local brain anatomy (no prior history of whole-brain radiotherapy, stereotactic radiosurgery, or brain surgery), and who are negative for actionable driver mutations or have experienced disease progression following prior targeted therapies.

Ages

18 years and older

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: * Age ≥ 18 years; no gender restriction; * Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI; * Scheduled to receive radiotherapy combined with a PD-1/PD-L1 inhibitor, in accordance with real-world clinical treatment plans; * Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy; * ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months; * Voluntarily signs the informed consent form and agrees to cooperate with blood/imaging data collection and follow-up procedures. Exclusion Criteria: * History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery; * Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency); * Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents; * Pregnant or lactating women; * Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm in the brain non-small cell lung carcinoma

As listed by the trial registrant

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

Brain metastasases Non-small-cell lung

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

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.