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

May 28, 2024 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

Multi-omics Evaluation System and Preferred Mode of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cohort A
Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy
Drug: Chemotherapy + immunotherapy
Chemotherapy + immunotherapy
Experimental: cohort B
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
Drug: Chemotherapy + immunotherapy
Chemotherapy + immunotherapy
Radiation: radiotherapy
Different cohorts received different doses of radiotherapy
Experimental: cohort C
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
Drug: Chemotherapy + immunotherapy
Chemotherapy + immunotherapy
Radiation: radiotherapy
Different cohorts received different doses of radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2 years from enrollment
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
up to 2 years from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2 years from enrollment
overall survival
Time Frame: up to 2 years from enrollment
the time from enrollment until death or the last follow-up
up to 2 years from enrollment
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
up to 2 years from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Province Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RENO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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