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Recruiting NCT05598528

Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

— Observational Lung Cancer, Non-small Cell EGFR Gene Mutation EGFR-TKI Resistant Mutation Primary Resistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genomic profiles detection, circulating tumor DNA detection.
Who it may be relevant to
Registry conditions: Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: 2 years]
  • Progression-free survival (PFS) [Time frame: 3 years]
  • Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant NSCLC. [Time frame: 3 years]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 5 years]
  • Disease Control Rate (DCR) [Time frame: 3 years]

Eligibility criteria

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

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;
  • Pregnant and lactating women;
  • Other malignant neoplastic diseases within 3 years;
  • Patients who have undergone other clinical drug trials;
  • Received systemic anti-tumor therapy within 2 years;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha

Identifiers

NCT: NCT05598528 · XYEYY20220928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗