Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer

Suspended

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: PD-1/PD-L1 inhibitor

• Registration Number: NCT04835025
• Lead Sponsor: Tongji Hospital

Brief Summary

This is a Retrospective, Multicenter, Controlled Study to Evaluate Immunotherapy and Radiotherpay for Brain Lesions as a Potential Treatment for Patients with Brain Metastasis in non-small cell lung cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Last Update Submitted: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Experimental group:

1. 18 years old ≤ age ≤ 75 years old, no gender limitation;
2. NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy;
3. Histologically confirmed as NSCLC;
4. Imaging confirmed brain metastasis (CT or MRI);
5. The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1

Control group:

1 18 years old ≤ age ≤ 75 years old, no gender limitation; 2 NSCLC who has received radiotherapy for brain lesions; 3 Histologically confirmed as non-small cell lung cancer; 4 Imaging confirmed brain metastasis (CT or MRI); 5 The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1

Exclusion Criteria

1 The age is less than 18 years old, regardless of gender; 2 Histologically confirmed as NSCLC 3 Imaging confirmed the absence of brain metastases 4 NSCLC with brain metastasis only received chemotherapy or targeted therapy, and did not receive radiotherapy or immunotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group (radiotherapy group)	PD-1/PD-L1 inhibitor	In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesion (without limitation of dose and treatment method for radiotherapy) , but not receiving immunotherapy. Those patients would enter the control group. After patients experiencing disease progression(PD) in this group, follow-up treatment does not include immunotherapy until tumor progression again or death.

Primary Outcome Measures

Name	Time	Method
progression-free surival	3 years	Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years	Overall survival: From the first administration to death from any cause

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China; 🇨🇳 Wuhan, Hubei, China