Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain radiotherapy.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung, Brain Metastasases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.
Overview
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.
Interventions
- Radiation Brain radiotherapy
Participants in this observational study receive standard-of-care radiotherapy for brain metastases combined with PD-1/PD-L1 immune checkpoint inhibitors. The specific radiotherapy parameters (e.g., technique, target volume, and dose) and immunotherapy details (e.g., specific drug type, dosage, and administration schedule) are entirely determined by the treating physicians or multidisciplinary team (MDT) based on current clinical guidelines and real-world practice. This study does not assign, a
Primary outcome measures
- Intracranial Progression-Free Survival (iPFS) [Time frame: 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).]
Secondary outcome measures (7)
- Intracranial Objective Response Rate (iORR) [Time frame: Up to approximately 2 years.]
- Overall Survival (OS) [Time frame: Up to approximately 2 years.]
- Duration of Response (DOR) [Time frame: Up to approximately 2 years.]
- Best Overall Response (BOR) [Time frame: Up to approximately 2 years.]
- Intracranial Disease Control Rate (iDCR) [Time frame: At 24 weeks]
- Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs) [Time frame: From enrollment up to 1 years after the last dose of immunotherapy.]
- Incidence of Radiation Necrosis and Severe Brain Edema [Time frame: Up to approximately 2 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT07638709 · 2026051108 · ZXQ2026B05