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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06422546

Acronym

pre-FLAME

Enrollment

950

Registered

2024-05-21

Start date

2022-01-15

Completion date

2025-06-15

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment	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

Other

Measure	Time frame	Description
describe the characteristics of genetic variation associated with oxitinib treatment	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

Countries

China

Outcome results