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

Non Small Cell Lung Cancer Clinical Trial

— pre-FLAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422546
• Other study ID #: pre-FLAME
• Status: Recruiting
• Start date: January 15, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: May 2024
• Source: Beijing Cancer Prevention & Treatment Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: June 15, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
China	Beijing Cancer Prevention society	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Prevention & Treatment Society	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	describe the characteristics of genetic variation associated with 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
Primary	changes in EGFR gene mutations	To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment	baseline and 3 weeks after oxitinib treatment
Secondary	Characteristics of EGFR gene mutation and efficacy of 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