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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: radiotherapy
* Drug: Chemotherapy + immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response rate | 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 | 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 | number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 2 years from enrollment |