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Recruiting NCT05584267

Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

Phase II Interventional Non Small Cell Lung Cancer

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: radiotherapy, Chemotherapy + immunotherapy.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer. 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 →

Unsure about the terms? Read our patient guide →

Official title

Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

Overview

This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.

Interventions

  • Radiation radiotherapy
    Different cohorts received different doses of radiotherapy
  • Drug Chemotherapy + immunotherapy
    Chemotherapy + immunotherapy

Primary outcome measures

  • Intracranial progression-free survival [Time frame: up to 2 years from enrollment]
  • sPFS [Time frame: up to 2 years from enrollment]
Secondary outcome measures (3)
  • Objective Response rate [Time frame: up to 2 years from enrollment]
  • overall survival [Time frame: up to 2 years from enrollment]
  • number of participants with treatment-related adverse events [Time frame: up to 2 years from enrollment]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years of age on day of signing informed consent
  • Histopathology confirmed non-small cell lung cancer
  • Asymptomatic brain metastases
  • EGFR/ALK ROS1 driver gene mutation negative
  • RECIST 1.1 based available assessment of lesions
  • ECOG 0-1
  • Brain metastases 1-4
  • Single lesion ≤4cm

Exclusion criteria

  • Patients with contraindication of chemotherapy Pregnant or breast feeding women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hunan Cancer Hospital — Changsha

Identifiers

NCT: NCT05584267 · RENO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗