Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study

NSCLC Clinical Trial

— BELLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575415
• Other study ID #: CTONG1905
• Status: Recruiting
• Start date: October 7, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2020
• Source: Guangdong Association of Clinical Trials
• Contact: Qing Zhou, PhD
• Phone: 862081884713
• Email: gzzhouqing[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: December 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Bevacizumab
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
• Erlotinib
Erlotinib 150mg, orally once a day
• Gefitinib
Gefitinib 250mg, orally once a day
• Icotinib
Icotinib 125mg three times a day
• Afatinib
Afatinib 40 mg or clinical routine dose once daily
• Dacomitinib
Dacomitinib 45mg or clinical routine dose once daily
• Osimertinib
Osimertinib 80 mg once daily

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Objective response rate (ORR) by investigator using RECIST v1.1	To evaluate the efficacy of bevacizumab combined with EGFR-TKIs in patients with NSCLC harbouring activating EGFR mutations, with or without EGFR T790M mutation,as measured by investigators assessed objective response rate 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.
Secondary	Disease control rate (DCR) by investigator using RECIST v1.1	Disease control rate (DCR) will be analyzed using similar method as objective response rate.	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.
Secondary	Overall survival	To evaluate the efficacy of bevacizumab combined with EGFR-TKIs in patients with NSCLC harbouring activating EGFR mutations,with or without EGFR T790M mutation,as measured by investigators assessed overall survival.	The primary analysis on overall survival is espected to perform on 48 months of follow-up.
Secondary	Incidence of Treatment-Emergent Adverse Events using CTCAE V5.0	To evaluate the incidence of Treatment-Emergent Adverse Events of bevacizumab combined with EGFR-TKIs in patients with NSCLC harbouring activating EGFR mutations,with or without EGFR T790M mutation.	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.