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

Recruitingn/aAges 18 Years - anyAllSecond Xiangya Hospital of Central South Universiโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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;
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What it tests

  • Genomic profiles detection
  • circulating tumor DNA detection
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Where

1 site
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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