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Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases

NCT07638709 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung
  • Brain Metastasases

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, 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.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2029-05-31
Completion
2030-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638709 on ClinicalTrials.gov