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A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC

A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC

Recruiting
18 years and older
All
Phase N/A

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Overview

To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC

Description

Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.

Eligibility

Inclusion Criteria:

  1. ≥18 years old male or female
  2. Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
  3. Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
  4. EGFR positive in blood or tissue tested in local laboratory;
  5. Sufficient blood samples can be provided for molecular detection;
  6. Signed informed consent forms are available.

Exclusion Criteria:

  1. Patients were unable to collect plasma samples at baseline;
  2. The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
  3. The patient refused subsequent treatment with oxitinib; 4)The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.

Study details
    Non Small Cell Lung Cancer

NCT06422546

Beijing Cancer Prevention & Treatment Society

29 May 2024

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