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

Recruiting now

Conditions studied: Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance, Circulating Tumor DNA

In brief

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.

Key facts

Study ID

NCT05598528

Run by

Second Xiangya Hospital of Central South University

People needed

210

Starts

2021-09-28

Expected to finish

2026-12-31

Last updated by the study team

2024-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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