Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
Second Xiangya Hospital of Central South University
210 participants
Sep 28, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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;
- Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);
- Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;
- 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;
- Agree to participate in this study and sign an informed consent form.
Exclusion Criteria5
- 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;
- Received systemic anti-tumor therapy within 2 years;
Interventions
The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing
The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05598528