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

Phase 2

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Chemotherapy + immunotherapy; Radiation: radiotherapy

• Registration Number: NCT05584267
• Lead Sponsor: Hunan Province Tumor Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-18
• Study Start: 2022-12-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-11-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort A	Chemotherapy + immunotherapy	Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy
cohort B	radiotherapy	Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
cohort B	Chemotherapy + immunotherapy	Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
cohort C	radiotherapy	Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
cohort C	Chemotherapy + immunotherapy	Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China