Trial Title:
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
NCT ID:
NCT05598528
Condition:
Lung Cancer, Non-small Cell
EGFR Gene Mutation
EGFR-TKI Resistant Mutation
Primary Resistance
Circulating Tumor DNA
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Genomic profiles detection
Description:
The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next-
generation gene sequencing
Arm group label:
EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy
Intervention type:
Other
Intervention name:
circulating tumor DNA detection
Description:
The Plasma at diagnosis and at 1-month treatment are collected and assessed by
Next-generation gene sequencing
Arm group label:
EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy
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.
Criteria for eligibility:
Study pop:
Stage IIIB-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib
80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age >18 years;
2. Histological or cytopathological diagnosed NSCLC;
3. 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;
4. At least one measurable lesion can be evaluated according to the Response Evaluation
Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;
5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal
fluid, etc.);
6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line
therapy;
7. Cooperate with the provision of clinicopathological data, imaging data, sample
collection, and follow-up required for the research process, and agree to use the
test data for subsequent research and product development;
8. Agree to participate in this study and sign an informed consent form.
Exclusion Criteria:
1. Patients who cannot understand the content of the experiment and cannot cooperate,
and those who refuse to sign the informed consent form;
2. Pregnant and lactating women;
3. Other malignant neoplastic diseases within 3 years;
4. Patients who have undergone other clinical drug trials;
5. Received systemic anti-tumor therapy within 2 years;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, The Second Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang Wu, MD, PhD
Phone:
+86 13574858332
Email:
wufang4461@csu.edu.cn
Start date:
September 28, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Second Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The Third Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Kunming Medical University
Agency class:
Other
Collaborator:
Agency:
Loudi Central Hospital
Agency class:
Other
Collaborator:
Agency:
ZhuZhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangtan Central Hospital
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Chenzhou
Agency class:
Other
Collaborator:
Agency:
Yueyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yongzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of University of South China
Agency class:
Other
Collaborator:
Agency:
Hunan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shaoyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yiyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Changsha Central Hospital
Agency class:
Other
Collaborator:
Agency:
The first people's hospital of Guiyang
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Renmin Hospital of Wuhan University
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Changde
Agency class:
Other
Collaborator:
Agency:
Zhuzhou Second Hospital
Agency class:
Other
Collaborator:
Agency:
First Hospital of Changsha
Agency class:
Other
Collaborator:
Agency:
Hengyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Huaihua first people's Hospital
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Xiangtan
Agency class:
Other
Collaborator:
Agency:
University of South China Affiliated Nanhua Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangxi Autonomous Prefecture People's Hospital
Agency class:
Other
Collaborator:
Agency:
People's Hospital of Zhangjiajie
Agency class:
Other
Collaborator:
Agency:
Second People's Hospital Of Huaihua
Agency class:
Other
Collaborator:
Agency:
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
Agency class:
Other
Collaborator:
Agency:
The Third Hospital of Changsha
Agency class:
Other
Collaborator:
Agency:
Xiangya Changde Hospital
Agency class:
Other
Collaborator:
Agency:
Changsha County first People's Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Provincial Straight Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Liuyang Hospital of traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Second People's Hospital of Hunan
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
Guiyang Public Health Treatment Center
Agency class:
Other
Collaborator:
Agency:
The Affiliated Bethune Hospital of Shanxi Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Hunan University of Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Source:
Second Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05598528
