Actively Recruiting

Age: 18Years +
All Genders
NCT05598528

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

Led by Second Xiangya Hospital of Central South University · Updated on 2024-12-02

210

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

Sponsors

S

Second Xiangya Hospital of Central South University

Lead Sponsor

X

Xiangya Hospital of Central South University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosed with non-small cell lung cancer (NSCLC) by tissue or cell analysis
  • Clinical stage IIIB to IV that cannot be removed by surgery or has recurrence/metastasis after surgery
  • At least one measurable tumor lesion according to standard criteria
  • Positive EGFR mutation confirmed by tissue or fluid samples
  • Using approved third-generation EGFR-TKIs as first-line treatment for NSCLC
  • Willing to provide clinical, imaging data, samples, and follow-up for research
  • Agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Unable to understand or cooperate with the study or refuse to sign consent
  • Pregnant or breastfeeding women
  • Any other cancer diagnosed within the past 3 years
  • Participation in other clinical drug trials
  • Received systemic anti-tumor therapy within the past 2 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, China, 410011

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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