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

Tongji Hospital

Status: Suspended

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: PD-1/PD-L1 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT04835025

TJ-IRB20210338

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Control group (radiotherapy group)

Description:

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.

Treatment:

Drug: PD-1/PD-L1 inhibitor