Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatme… (NCT05598528) | Clinical Trial Compass
RecruitingNot Applicable
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
China210 participantsStarted 2021-09-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 2 years
2
Progression-free survival (PFS)
Timeframe: 3 years
3
Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant NSCLC.
Timeframe: 3 years
Trial details
NCT IDNCT05598528
SponsorSecond Xiangya Hospital of Central South University