Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study
BELLA
Bevacizumab 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
1 other identifier
observational
272
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
October 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 20, 2020
October 1, 2020
2.6 years
September 8, 2020
October 17, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1
To evaluate the efficacy of bevacizumab combined with first-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators
This is a real-world study. The estimated median PFS for bevacizumab plus first-generation EGFR-TKIs is 18 months according to previous data.
Progression-free survival (PFS) for bevacizumab plus second-generation EGFR-TKIs by investigator using RECIST v1.1
To evaluate the efficacy of bevacizumab combined with second-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators.
This is a real-world study. The estimated median PFS for bevacizumab plus second-generation EGFR-TKIs is 20 months according to previous data.
Progression-free survival (PFS) for bevacizumab plus third-generation EGFR-TKIs by investigator using RECIST v1.1
To evaluate the efficacy of bevacizumab combined with third-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators.
This is a real-world study. The estimated median PFS for bevacizumab plus third-generation EGFR-TKIs is 22 months according to previous data.
Secondary Outcomes (4)
Objective response rate (ORR) by investigator using RECIST v1.1
Baseline overall tumor assessment can be performed up to 28 days after the first-dose of treatment. Post-baseline assessment will be performed every six weeks until 1st disease progression, through study completion, an average of 2 years.
Disease control rate (DCR) by investigator using RECIST v1.1
Baseline overall tumor assessment can be performed up to 28 days after the first-dose of treatment. Post-baseline assessment will be performed every six weeks until 1st disease progression, through study completion, an average of 2 years.
Overall survival
The primary analysis on overall survival is espected to perform on 48 months of follow-up.
Incidence of Treatment-Emergent Adverse Events using CTCAE V5.0
This is a real-world study. Safety of the combination treatment is expected to perform until the study completion, an average of 1.5 years,according to CTCAE V5.0.
Study Arms (3)
Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib
Patients with EGFR-mutant NSCLC would receive bevacizumab plus first-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks. Erlotinib 150 mg tablets once daily or Gefitinib 250mg once daily or Icotinib 125mg three times a day would be administered.
Arm 2:Bevacizumab plus Afatinib/Dacomitinib
Patients with EGFR-mutant NSCLC would receive bevacizumab plus second-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks.Afatinib 40 mg or clinical routine dose once daily or Dacomitinib 45mg or clinical routine dose once daily or clinical routine dose would be administered.
Arm 3:Bevacizumab plus Osimertinib
Patients with EGFR-mutant NSCLC would receive bevacizumab plus third-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks. Osimertinib 80 mg tablets once daily would be administered.
Interventions
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
Erlotinib 150mg, orally once a day
Gefitinib 250mg, orally once a day
Icotinib 125mg three times a day
Afatinib 40 mg or clinical routine dose once daily
Dacomitinib 45mg or clinical routine dose once daily
Osimertinib 80 mg once daily
Eligibility Criteria
Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC) or metastatic (Stage IV) non-squamous NSCLC with EGFR exon 19 deletion or/and exon 21L858R mutation, with or without EGFR T790M mutation, who meet the inclusion criteria will be enrolled in this study.
You may qualify if:
- Patients must meet the following criteria for study entry:
- Signed Informed Consent Form.
- Age≥18 years.
- Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC), metastatic (Stage IV) or recurrent non-squamous NSCLC.
- An exon 19 deletion mutation or exon 21 L858R mutation in EGFR has been found clinically, with or without EGFR T790M mutation
- Eastern Cooperative Oncology Group performance status 0-2 or KPS ≥60
- Previous EGFR-TKIs or anti-angiogenic agents or systemic cytotoxic chemotherapy for locally advanced, metastatic or recurrent disease has not been performed.
You may not qualify if:
- Patients who meet any of the following criteria will be excluded from study entry:
- Squamous carcinoma or mixed non-small cell lung cancer with squamous component.
- Potential hazard for receiving EGFR-TKIs or bevacizumab by clinical evaluations
- Previous history of receiving EGFR-TKIs or bevacizumab treatment prior to study enrollment
- Suspected or diagnosed leptomeningeal metastases
- Chest radiotherapy within 3 months prior to study enrollment
- Open surgery within 4 weeks prior to study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qing Zhou, PhD
Guangdong Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
October 5, 2020
Study Start
October 7, 2020
Primary Completion
May 1, 2023
Study Completion
December 1, 2023
Last Updated
October 20, 2020
Record last verified: 2020-10