Back to resultsImmune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
Primary Purpose
Non Small Cell Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiotherapy
Chemotherapy + immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
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
Sites / Locations
- Hunan Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
cohort A
cohort B
cohort C
Arm Description
Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
Outcomes
Primary Outcome Measures
Intracranial progression-free survival
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
sPFS
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Secondary Outcome Measures
Objective Response rate
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
overall survival
the time from enrollment until death or the last follow-up
number of participants with treatment-related adverse events
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
NCT ID
NCT05584267
First Posted
October 14, 2022
Last Updated
February 28, 2023
Sponsor
Hunan Province Tumor Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05584267
Brief Title
Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
Official Title
Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Province Tumor Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cohort A
Arm Type
Active Comparator
Arm Description
Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy
Arm Title
cohort B
Arm Type
Experimental
Arm Description
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
Arm Title
cohort C
Arm Type
Experimental
Arm Description
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Different cohorts received different doses of radiotherapy
Intervention Type
Drug
Intervention Name(s)
Chemotherapy + immunotherapy
Intervention Description
Chemotherapy + immunotherapy
Primary Outcome Measure Information:
Title
Intracranial progression-free survival
Description
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Time Frame
up to 2 years from enrollment
Title
sPFS
Description
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Time Frame
up to 2 years from enrollment
Secondary Outcome Measure Information:
Title
Objective Response rate
Description
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Time Frame
up to 2 years from enrollment
Title
overall survival
Description
the time from enrollment until death or the last follow-up
Time Frame
up to 2 years from enrollment
Title
number of participants with treatment-related adverse events
Description
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
up to 2 years from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongchang C Zhang, MD
Phone
+8613873123436
Ext
7+861383123436
Email
zhangyongchang@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Nong C Yang, MD
Phone
+8613873123436
Ext
+8613873123436
Email
yangnong0217@163.com
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
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