Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor DNA | — | UNRESOLVED | — |
| EGFR Gene Mutation | — | UNRESOLVED | — |
| EGFR-TKI Resistant Mutation | — | UNRESOLVED | — |
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Primary Resistance | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| circulating tumor DNA detection | Other | — | UNRESOLVED |
| Genomic profiles detection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy
- description
- Stage III-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.
- interventionNames
- Other: Genomic profiles detection
- Other: circulating tumor DNA detection
Primary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 years
- description
- The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 3 years
- description
- Time from the beginning of treatment to the first disease progression (PD) in patients with advanced NSCLC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available