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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

Qualifiers

Age >18 years;

Histological or cytopathological diagnosed NSCLC;

According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;

At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;

Disqualifiers

Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;

Pregnant and lactating women;

Other malignant neoplastic diseases within 3 years;

Patients who have undergone other clinical drug trials;

Trial design

Treatments tested in this trial

  • Genomic profiles detection
  • circulating tumor DNA detection

Treatment groups

210 Participants
are divided into 1 treatment group

Sponsors and collaborators

Second Xiangya Hospital of Central South University

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

Shanghai Chest Hospital

Collaborator

West China Hospital

Collaborator

Hunan Cancer Hospital

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

The First Affiliated Hospital of Xiamen University

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

China-Japan Friendship Hospital

Collaborator

Fudan University

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Loudi Central Hospital

Collaborator

ZhuZhou Central Hospital

Collaborator

Xiangtan Central Hospital

Collaborator

First People's Hospital of Chenzhou

Collaborator

Yueyang Central Hospital

Collaborator

Yongzhou Central Hospital

Collaborator

The First Affiliated Hospital of University of South China

Collaborator

Hunan Provincial People's Hospital

Collaborator

Shaoyang Central Hospital

Collaborator

Yiyang Central Hospital

Collaborator

Changsha Central Hospital

Collaborator

The First People's Hospital of Guiyang

Collaborator

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

Collaborator

Renmin Hospital of Wuhan University

Collaborator

The First People's Hospital of Changde City

Collaborator

Zhuzhou Second Hospital

Collaborator

First Hospital of Changsha

Collaborator

Hengyang Central Hospital

Collaborator

Huaihua first people's Hospital

Collaborator

The First People's Hospital of Xiangtan

Collaborator

University of South China Affiliated Nanhua Hospital

Collaborator

Xiangxi Autonomous Prefecture People's Hospital

Collaborator

People's Hospital of Zhangjiajie

Collaborator

Second People's Hospital Of Huaihua

Collaborator

Hunan Academy of Traditional Chinese Medicine Affiliated Hospital

Collaborator

The Third Hospital of Changsha

Collaborator

Xiangya Changde Hospital

Collaborator

Changsha County first People's Hospital

Collaborator

Hunan Provincial Straight Hospital of Traditional Chinese Medicine

Collaborator

Liuyang Hospital of traditional Chinese Medicine

Collaborator

Second People's Hospital of Hunan

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

Guiyang Public Health Treatment Center

Collaborator

The Affiliated Bethune Hospital of Shanxi Medical University

Collaborator

Hunan University of Traditional Chinese Medicine

Collaborator

Tongji Hospital

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator