Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ZXQ2026B05 | Other Grant/Funding Number | Central South University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-small cell lung cancer brain metastases | This cohort comprises adult patients (aged 18 years and older) with histologically or cytologically confirmed (NSCLC who have brain metastases confirmed by contrast-enhanced head MRI. Participants in this cohort are scheduled to receive standard-of-care radiotherapy combined with PD-1/PD-L1 immune checkpoint inhibitors based on real-world clinical treatment plans. Eligible participants must have an ECOG performance status of 0 to 2, an expected survival of at least 3 months, and be either driver-gene negative or have experienced disease progression following prior targeted therapies. The cohort strictly excludes patients who have a history of WBRT, SRS for brain metastases, or brain surgery. Additionally, individuals with contraindications to MRI (or intolerance to gadolinium contrast agents), active autoimmune diseases requiring systemic treatment or long-term high-dose immunosuppressants, and pregnant or lactating women are excluded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain radiotherapy | Radiation | 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, alter, or proactively intervene in any treatment plans. What distinguishes the exposure in this study is the specific tracking and categorization of the real-world timing interval and administration sequence between radiotherapy and immunotherapy (e.g., synchronous vs. asynchronous, radiation-first vs. immunotherapy-first), aiming to evaluate how these naturally occurring temporal variations impact clinical outcomes and immune status. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Progression-Free Survival (iPFS) | Defined as the time from study enrollment (or completion of baseline assessment) to the first documented intracranial disease progression according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria via blinded independent central review, or death from any cause. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Objective Response Rate (iORR) | The proportion of patients achieving an intracranial Complete Response (CR) or Partial Response (PR) per RANO-BM criteria. Responses must be confirmed by consecutive imaging assessments at least 4 weeks apart. | Up to approximately 2 years. |
| Overall Survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Parasagittal Dura (PSD) Volume | Quantitative measurement of the parasagittal dura (PSD) volume derived from contrast-enhanced 7.0T MRI. PSD volume will be calculated using standardized image segmentation and volumetric analysis procedures and reported in cubic millimeters (mm³). | Baseline and follow-up MRI assessments up to approximately 2 years. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongrong Zhou, MD, PHD | Contact | +8613875898127 | zhourr@csu.edu.cn | |
| Weihua Liao, MD, PHD | Contact | +8613973126486 | ouwenliao@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
IPD will not be made publicly available on open-access platforms to safeguard patient privacy. However, de-identified and aggregated datasets, or specific subsets of IPD underlying the published results, might be shared conditionally. Such data will only be provided upon reasonable request from qualified academic researchers, subject to the approval of the Institutional Review Board (IRB) of Xiangya Hospital and the execution of a formal Data Use Agreement (DUA).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Defined as the time from study enrollment to death from any cause. |
| Up to approximately 2 years. |
| Duration of Response (DOR) | For patients achieving confirmed CR or PR, defined as the time from the first documented objective response to the first documented disease progression or death from any cause. | Up to approximately 2 years. |
| Best Overall Response (BOR) | The best disease response recorded from the start of the study treatment until disease progression or recurrence. | Up to approximately 2 years. |
| Intracranial Disease Control Rate (iDCR) | The proportion of patients who achieve CR, PR, or Stable Disease (SD) maintained for at least a specified time period (e.g., 24 weeks). | At 24 weeks |
| Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs) | Evaluated and tracked according to the NCI CTCAE v5.0 and specific irAE management guidelines to assess the safety of different treatment sequences. | From enrollment up to 1 years after the last dose of immunotherapy. |
| Incidence of Radiation Necrosis and Severe Brain Edema | Dynamic monitoring and evaluation of the occurrence of radiation necrosis and Grade ≥3 radiation-induced brain edema, utilizing RANO-BM and related imaging criteria. | Up to approximately 2 years. |
| Meningeal Lymphatic Drainage Rate |
Quantitative assessment of meningeal lymphatic drainage efficiency measured using contrast-enhanced 7.0T MRI. Drainage rate will be calculated according to predefined imaging analysis protocols and expressed as a percentage or kinetic parameter reflecting lymphatic drainage function. |
| Baseline and follow-up MRI assessments up to approximately 2 years. |
| Meningeal Lymphatic Vessel Diameter | Mean diameter of visualized meningeal lymphatic vessels measured on contrast-enhanced 7.0T MRI using standardized image analysis methods and reported in millimeters (mm). | Baseline and follow-up MRI assessments up to approximately 2 years. |
| Deep Cervical Lymph Node (dCLN) Inflow Rate | Quantitative assessment of contrast agent inflow into deep cervical lymph nodes measured using contrast-enhanced 7.0T MRI. The inflow rate will be used as an indicator of meningeal lymphatic drainage function. | Baseline and follow-up MRI assessments up to approximately 2 years. |