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

NCT06422546 | Recruiting

• 1 other identifier: pre-FLAME
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Characteristics of EGFR gene mutation and efficacy of oxitinib treatment

  baseline and 3 weeks after oxitinib treatment

Other Outcomes (1)

• describe the characteristics of genetic variation associated with oxitinib treatment

  baseline and 3 weeks after oxitinib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ≥18 years old male or female
• Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
• Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
• EGFR positive in blood or tissue tested in local laboratory;
• Sufficient blood samples can be provided for molecular detection;
• Signed informed consent forms are available.

You may not qualify if:

• Patients were unable to collect plasma samples at baseline;
• The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
• 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.

Sponsors & Collaborators

• Beijing Cancer Prevention & Treatment Society: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Beijing Cancer Prevention society

Beijing, Beijing Municipality, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EGFR mutation in plasma

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: January 15, 2022
• Primary Completion: July 31, 2024
• Study Completion: June 15, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)