Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05584267

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Different cohorts received different doses of radiotherapy

Chemotherapy + immunotherapy

Drug

Chemotherapy + immunotherapy

Primary outcomes

  1. Intracranial progression-free survival

    Time frame: up to 2 years from enrollment

    assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI

  2. sPFS

    Time frame: up to 2 years from enrollment

    assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI

Secondary outcomes

  1. Objective Response rate

    Time frame: up to 2 years from enrollment

    assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI

  2. overall survival

    Time frame: up to 2 years from enrollment

    the time from enrollment until death or the last follow-up

  3. number of participants with treatment-related adverse events

    Time frame: up to 2 years from enrollment

    number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Study contacts

Contact information is provided by the study sponsor or research team.

Nong C Yang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

Yongchang C Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 18, 2022
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.