Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

Summary

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.

However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.

This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.

Conditions

• Lung Cancer, Non-small Cell
• EGFR Gene Mutation
• EGFR-TKI Resistant Mutation
• Primary Resistance
• Circulating Tumor DNA

Interventions

OTHER

Genomic profiles detection

The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing

OTHER

circulating tumor DNA detection

The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Loudi Central Hospital

  collaborator OTHER

• ZhuZhou Central Hospital

  collaborator OTHER

• Xiangtan Central Hospital

  collaborator OTHER

• First People's Hospital of Chenzhou

  collaborator OTHER

• Yueyang Central Hospital

  collaborator OTHER

• Yongzhou Central Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of University of South China

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Shaoyang Central Hospital

  collaborator UNKNOWN

• Yiyang Central Hospital

  collaborator UNKNOWN

• Changsha Central Hospital

  collaborator OTHER

• The first people's hospital of Guiyang

  collaborator UNKNOWN

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

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• The First People's Hospital of Changde City

  collaborator OTHER

• Zhuzhou Second Hospital

  collaborator UNKNOWN

• First Hospital of Changsha

  collaborator UNKNOWN

• Hengyang Central Hospital

  collaborator OTHER_GOV

• Huaihua first people's Hospital

  collaborator UNKNOWN

• The First People's Hospital of Xiangtan

  collaborator UNKNOWN

• University of South China Affiliated Nanhua Hospital

  collaborator UNKNOWN

• Xiangxi Autonomous Prefecture People's Hospital

  collaborator UNKNOWN

• People's Hospital of Zhangjiajie

  collaborator UNKNOWN

• Second People's Hospital Of Huaihua

  collaborator UNKNOWN

• Hunan Academy of Traditional Chinese Medicine Affiliated Hospital

  collaborator UNKNOWN

• The Third Hospital of Changsha

  collaborator UNKNOWN

• Xiangya Changde Hospital

  collaborator UNKNOWN

• Changsha County first People's Hospital

  collaborator UNKNOWN

• Hunan Provincial Straight Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Liuyang Hospital of traditional Chinese Medicine

  collaborator UNKNOWN

• Second People's Hospital of Hunan

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Guiyang Public Health Treatment Center

  collaborator UNKNOWN

• The Affiliated Bethune Hospital of Shanxi Medical University

  collaborator UNKNOWN

• Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-28

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• China

Study Locations