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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 | Clinical Trials | Clareo Health

RECRUITING

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 Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC

NCT06422546•Beijing Cancer Prevention & Treatment Society

View on ClinicalTrials.gov

Summary

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

Detailed 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Beijing Cancer Prevention society

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 15, 2022

Primary Completion Date

July 31, 2024

Completion Date

June 15, 2025

Last Updated

May 21, 2024

Enrollment

950

ESTIMATED participants

Conditions

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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