Understanding why some lung cancer patients don't respond to new treatments
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)
This study is trying to understand why some patients with advanced lung cancer don't respond to new treatments so that doctors can better tailor therapies to help them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05598528 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the mechanisms behind primary resistance to third-generation EGFR-TKIs in patients with EGFR-positive advanced non-small cell lung cancer (NSCLC). It aims to identify molecular indicators that predict the effectiveness of these treatments and clarify the reasons for resistance. By analyzing genomic profiles and circulating tumor DNA, the study seeks to enhance clinical decision-making and treatment strategies for NSCLC patients. The findings could lead to improved patient outcomes by tailoring therapies based on individual resistance mechanisms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with histologically or cytopathologically diagnosed unresectable stage IIIB-IV NSCLC and confirmed EGFR mutations.
Not a fit: Patients with NSCLC who do not have EGFR mutations or are not receiving third-generation EGFR-TKIs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are likely to benefit from third-generation EGFR-TKIs, leading to more effective treatment strategies for lung cancer.
How similar studies have performed: Other studies have explored resistance mechanisms in lung cancer, but this specific focus on third-generation EGFR-TKIs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Changsha, Hunan
- Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.