Trials / Recruiting
RecruitingNCT05598528
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 210 (estimated)
- Sponsor
- Second Xiangya Hospital of Central South University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Lung Cancer, Non-small Cell
- EGFR Gene Mutation
- EGFR-TKI Resistant Mutation
- Primary Resistance
- Circulating Tumor DNA
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Genomic profiles detection | The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing |
| OTHER | circulating tumor DNA detection | The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing |
Timeline
- Start date
- 2021-09-28
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2022-10-28
- Last updated
- 2024-12-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05598528. Inclusion in this directory is not an endorsement.