Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

9 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

150

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Rongrong Zhou, MD, PHD
  • Numéro de téléphone: +8613875898127
  • E-mail: zhourr@csu.edu.cn

Sauvegarde des contacts de l'étude

  • Nom: Weihua Liao, MD, PHD
  • Numéro de téléphone: +8613973126486
  • E-mail: ouwenliao@163.com

Lieux d'étude

  • Chine
    • Hunan
      • Changsha, Hunan, Chine
        • Xiangya Hospital of Central South University
        • Contact:
          • Rongrong Zhou, MD, PHD
          • Numéro de téléphone: +8613875898127
          • E-mail: zhourr@csu.edu.cn
        • Contact:
          • Weihua Liao, MD, PHD
          • Numéro de téléphone: +8613973126486
          • E-mail: ouwenliao@163.com
        • Sous-enquêteur:
          • Xianjing Chu, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
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, 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Intracranial Progression-Free Survival (iPFS)
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Intracranial Objective Response Rate (iORR)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Parasagittal Dura (PSD) Volume
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Xiangya Hospital of Central South University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

5 juin 2026

Achèvement primaire (Estimé)

31 mai 2029

Achèvement de l'étude (Estimé)

1 juin 2030

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2026051108
  • ZXQ2026B05 (Autre subvention/numéro de financement: Central South University)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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).

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner