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

Sponsor

Hunan Province Tumor Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05584267

Collaborator

(none)

140

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Radiation: radiotherapy Drug: Chemotherapy + immunotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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	Radiation: radiotherapy Different cohorts received different doses of radiotherapy Drug: Chemotherapy + immunotherapy Chemotherapy + immunotherapy
Experimental: cohort C Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total	Radiation: radiotherapy Different cohorts received different doses of radiotherapy Drug: Chemotherapy + immunotherapy Chemotherapy + immunotherapy

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

Radiation: radiotherapy

Different cohorts received different doses of radiotherapy

Drug: Chemotherapy + immunotherapy

Chemotherapy + immunotherapy

Experimental: cohort C

Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total

Radiation: radiotherapy

Different cohorts received different doses of radiotherapy

Drug: Chemotherapy + immunotherapy

Chemotherapy + immunotherapy

Outcome Measures

Primary Outcome Measures

Intracranial progression-free survival [up to 2 years from enrollment]
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
sPFS [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 Outcome Measures

Objective Response rate [up to 2 years from enrollment]
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
overall survival [up to 2 years from enrollment]
the time from enrollment until death or the last follow-up
number of participants with treatment-related adverse events [up to 2 years from enrollment]
number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Cancer Hospital	Changsha	Hunan	China	410013

Sponsors and Collaborators

Hunan Province Tumor Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongchang Zhang, Professor, Hunan Province Tumor Hospital

ClinicalTrials.gov Identifier:

NCT05584267

Other Study ID Numbers:

RENO

First Posted:

Oct 18, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Brain Neoplasms

Study Results

No Results Posted as of Oct 18, 2022