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

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Oct 25, 2022

Keywords

ClinConnect Summary

The PRECISE Study is a clinical trial aimed at understanding why some patients with advanced non-small cell lung cancer (NSCLC) do not respond to a specific type of medication called third-generation EGFR-TKIs, which are used for treating tumors with certain genetic changes (EGFR mutations). Even though these medications can be very effective, about 20% of patients with EGFR-positive lung cancer experience what is called "primary resistance," meaning their cancer does not improve or gets worse shortly after starting treatment. This study seeks to identify the molecular signs that can predict who will benefit from these medications and to explore the reasons behind this resistance.

To participate in this trial, patients must be at least 18 years old and have been diagnosed with NSCLC that is either advanced or has returned after treatment. They should have a confirmed EGFR mutation and be willing to undergo regular monitoring and provide necessary medical information. Participants can expect to contribute to important research that could help improve treatment strategies for lung cancer in the future. It’s important to note that not everyone will be eligible, as certain health conditions and previous treatments may disqualify potential participants.

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Eligibility 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;