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Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases ((RT-ICI))

9 giugno 2026 aggiornato da: Rongrong Zhou, Xiangya Hospital of Central South University

Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

150

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Rongrong Zhou, MD, PHD
  • Numero di telefono: +8613875898127
  • Email: zhourr@csu.edu.cn

Backup dei contatti dello studio

  • Nome: Weihua Liao, MD, PHD
  • Numero di telefono: +8613973126486
  • Email: ouwenliao@163.com

Luoghi di studio

  • Cina
    • Hunan
      • Changsha, Hunan, Cina
        • Xiangya Hospital of Central South University
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Xianjing Chu, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Radiazione: 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, 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intracranial Progression-Free Survival (iPFS)
Lasso di tempo: 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).
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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intracranial Objective Response Rate (iORR)
Lasso di tempo: Up to approximately 2 years.
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)
Lasso di tempo: Up to approximately 2 years.
Defined as the time from study enrollment to death from any cause.
Up to approximately 2 years.
Duration of Response (DOR)
Lasso di tempo: Up to approximately 2 years.
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)
Lasso di tempo: Up to approximately 2 years.
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)
Lasso di tempo: At 24 weeks
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)
Lasso di tempo: From enrollment up to 1 years after the last dose of immunotherapy.
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
Lasso di tempo: Up to approximately 2 years.
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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Parasagittal Dura (PSD) Volume
Lasso di tempo: Baseline and follow-up MRI assessments up to approximately 2 years.
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.
Meningeal Lymphatic Drainage Rate
Lasso di tempo: Baseline and follow-up MRI assessments up to approximately 2 years.
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
Lasso di tempo: Baseline and follow-up MRI assessments up to approximately 2 years.
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
Lasso di tempo: Baseline and follow-up MRI assessments up to approximately 2 years.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xiangya Hospital of Central South University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 giugno 2026

Completamento primario (Stimato)

31 maggio 2029

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026051108
  • ZXQ2026B05 (Altro numero di sovvenzione/finanziamento: Central South University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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