NCT05598528 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Lung Cancer, Non-small Cell |
| Study Type | OBSERVATIONAL |
| Enrollment | 210 participants |
| Start Date | 2021-09-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 210 participants in total. It began in 2021-09-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Frequently Asked Questions
Who can join the NCT05598528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer, Non-small Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05598528 currently recruiting?
Yes, NCT05598528 is actively recruiting participants. Visit ClinicalTrials.gov or contact Second Xiangya Hospital of Central South University to inquire about joining.
Where is the NCT05598528 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05598528 clinical trial?
NCT05598528 is sponsored by Second Xiangya Hospital of Central South University. The trial plans to enroll 210 participants.
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