BELLABevacizumab Plus EGFR Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB-IV EGFR-mutant Non-small Cell Lung Cancer: a Prospective,Multicenter, Non-interventional,Real-world Study
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 7, 2020
Actual date on which the first participant was enrolled.This study is a prospective, multicenter, real-world study to investigate the efficacy and safety of bevacizumab plus epidermal growth factor (EGFR) Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB/IV EGFR-mutant Non-small Cell Lung Cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.272 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Patients must meet the following criteria for study entry: 1. Signed Informed Consent Form. 2. Age≥18 years. 3. Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC), metastatic (Stage IV) or recurrent non-squamous NSCLC. 4. An exon 19 deletion mutation or exon 21 L858R mutation in EGFR has been found clinically, with or without EGFR T790M mutation 5. Eastern Cooperative Oncology Group performance status 0-2 or KPS ≥60 6. Previous EGFR-TKIs or anti-angiogenic agents or systemic cytotoxic chemotherapy for locally advanced, metastatic or recurrent disease has not been performed. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from study entry: 1. Squamous carcinoma or mixed non-small cell lung cancer with squamous component. 2. Potential hazard for receiving EGFR-TKIs or bevacizumab by clinical evaluations 3. Previous history of receiving EGFR-TKIs or bevacizumab treatment prior to study enrollment 4. Suspected or diagnosed leptomeningeal metastases 5. Chest radiotherapy within 3 months prior to study enrollment 6. Open surgery within 4 weeks prior to study enrollment
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Guangdong Provincial People's Hospital
Guangzhou, ChinaOpen Guangdong Provincial People's Hospital in Google Maps