SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

Summary

Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.

Conditions

• Brain Metastases
• Non-small Cell Lung Cancer

Interventions

DRUG

EGFR-TK Inhibitor

Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.

RADIATION

Stereotactic radiotherapy

Patients with oligo-residual intracranial disease after treatment with EGFR-TKI will be treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist.

Sponsors & Collaborators

• Fudan University

  lead OTHER

Principal Investigators

• Zhengfei Zhu, MD · Fudan University

• Xuwei Cai · Shanghai Chest Hospital

• Qian Chu · Tongji Hospital

• Xiaorong Dong · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Lin Wu · Hunan Cancer Hospital

• Rongrong Zhou · Xiangya Hospital of Central South University

• Guang Han · Hubei Cancer Hospital

• Hui Zhu · Shandong Cancer Hospital and Institute

• Jinjun Ye · Jiangsu Cancer Institute & Hospital

• Xiaojia Cui · The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

• Guomei Tai · The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

• Zhiyong Yuan · Tianjin Medical University Cancer Institute and Hospital

• Dejun XIng · Jilin Provincial Tumor Hospital

• Jichen Ren · Jilin Provincial Tumor Hospital

• Jiancheng Li · Fujian Cancer Hospital

• Yanyang Wang · General Hospital of Ningxia Medical University

• Chuangzhou Rao · Ningbo No.2 Hospital

• Bing Lu · The Affiliated Hospital Of Guizhou Medical University

• Zhongyi Dong · Nanfang Hospital, Southern Medical University

• Jiwei Liu · The First Affiliated Hospital of Dalian Medical University

• Zhenzhou Yang · The Second Affiliated Hospital of Chongqing Medical University

• Hongqing Zhuang · Peking University Third Hospital

• Anwen Liu · Nanchang University Second Affiliated Hospital

• Haihua Yang · Taizhou Hospital Affiliated to Wenzhou Medical University

• Fang Liu · Chinese PLA General Hospital

• Yong Mao · Affiliated Hospital of Jiangnan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-10

Primary Completion

2027-08-10

Completion

2028-08-10

Countries

• China

Study Locations