Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedStudy Start
First participant enrolled
December 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMay 30, 2024
May 1, 2024
2.9 years
October 14, 2022
May 28, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Intracranial progression-free survival
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
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 Outcomes (3)
Objective Response rate
up to 2 years from enrollment
overall survival
up to 2 years from enrollment
number of participants with treatment-related adverse events
up to 2 years from enrollment
Study Arms (3)
cohort A
ACTIVE COMPARATORChemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy
cohort B
EXPERIMENTALChemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
cohort C
EXPERIMENTALChemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with contraindication of chemotherapy Pregnant or breast feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 18, 2022
Study Start
December 25, 2022
Primary Completion
November 1, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
May 30, 2024
Record last verified: 2024-05