Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases (NCT07638709) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases
China150 participantsStarted 2026-06-05
Plain-language summary
The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are:
1. Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?
2. What medical problems do participants have when receiving these treatments at different times?
3. How does the timing of treatments affect the body's immune system?
Researchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety.
Participants already receiving radiation and immunotherapy as part of their regular medical care will:
1. Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.
2. Give a small blood sample during their routine blood draws.
3. Have standard magnetic resonance imaging (MRI) scans of their brain.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intracranial Progression-Free Survival (iPFS)
Timeframe: Up to approximately 2 years (Assessed every 2-3 months in the first year, and every 3-6 months thereafter until disease progression or death).
Trial details
NCT IDNCT07638709
SponsorXiangya Hospital of Central South University