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
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2021-09-28
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy
Stage III-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.
Genomic profiles detection
The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing
circulating tumor DNA detection
The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing
Interventions
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Genomic profiles detection
The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing
circulating tumor DNA detection
The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Shanghai Chest Hospital
OTHER
West China Hospital
OTHER
Hunan Cancer Hospital
OTHER
The Third Xiangya Hospital of Central South University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
China-Japan Friendship Hospital
OTHER
Fudan University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Loudi Central Hospital
OTHER
ZhuZhou Central Hospital
OTHER
Xiangtan Central Hospital
OTHER
First People's Hospital of Chenzhou
OTHER
Yueyang Central Hospital
OTHER
Yongzhou Central Hospital
UNKNOWN
The First Affiliated Hospital of University of South China
OTHER
Hunan Provincial People's Hospital
OTHER
Shaoyang Central Hospital
UNKNOWN
Yiyang Central Hospital
UNKNOWN
Changsha Central Hospital
OTHER
The first people's hospital of Guiyang
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Renmin Hospital of Wuhan University
OTHER
The First People's Hospital of Changde City
OTHER
Zhuzhou Second Hospital
UNKNOWN
First Hospital of Changsha
UNKNOWN
Hengyang Central Hospital
OTHER_GOV
Huaihua first people's Hospital
UNKNOWN
The First People's Hospital of Xiangtan
UNKNOWN
University of South China Affiliated Nanhua Hospital
UNKNOWN
Xiangxi Autonomous Prefecture People's Hospital
UNKNOWN
People's Hospital of Zhangjiajie
UNKNOWN
Second People's Hospital Of Huaihua
UNKNOWN
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
UNKNOWN
The Third Hospital of Changsha
UNKNOWN
Xiangya Changde Hospital
UNKNOWN
Changsha County first People's Hospital
UNKNOWN
Hunan Provincial Straight Hospital of Traditional Chinese Medicine
UNKNOWN
Liuyang Hospital of traditional Chinese Medicine
UNKNOWN
Second People's Hospital of Hunan
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Guiyang Public Health Treatment Center
UNKNOWN
The Affiliated Bethune Hospital of Shanxi Medical University
UNKNOWN
Hunan University of Traditional Chinese Medicine
OTHER
Tongji Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Fang Wu
Associate Professor
Locations
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Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Facility Contacts
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Other Identifiers
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XYEYY20220928
Identifier Type: -
Identifier Source: org_study_id