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

Last updated: May 15, 2024
Sponsor: Beijing Cancer Prevention & Treatment Society
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06422546
pre-FLAME
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 (AJCCV8);

  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

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 beenverified by the central laboratory;

  3. The patient refused subsequent treatment with oxitinib; 4)The investigatordetermines that may affect the conduct of the clinical study and the judgement ofthe study results.

Study Design

Total Participants: 950
Study Start date:
January 15, 2022
Estimated Completion Date:
June 15, 2025

Study 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.

Connect with a study center

  • Beijing Cancer Prevention society

    Beijing, Beijing 100021
    China

    Active - Recruiting

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