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 (pre-FLAME)

May 15, 2024 updated by: Beijing Cancer Prevention & Treatment Society

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in EGFR gene mutations
Time Frame: baseline and 3 weeks after oxitinib treatment
To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment
baseline and 3 weeks after oxitinib treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment
Time Frame: baseline and 3 weeks after oxitinib treatment
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment
baseline and 3 weeks after oxitinib treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
describe the characteristics of genetic variation associated with oxitinib treatment
Time Frame: baseline and 3 weeks after oxitinib 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
baseline and 3 weeks after oxitinib treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Cancer Prevention & Treatment Society

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pre-FLAME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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