Understanding why some lung cancer patients don't respond to new treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Oncology, The Second Xiangya Hospital, Central South University
  Changsha, Hunan, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.