BELLA: Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Bevacizumab
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
Other Names:
Drug: Erlotinib
Erlotinib 150mg, orally once a day
Other Names:
Drug: Gefitinib
Gefitinib 250mg, orally once a day
Other Names:
Drug: Icotinib
Icotinib 125mg three times a day
Other Names:
|
| 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. |
Drug: Bevacizumab
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
Other Names:
Drug: Afatinib
Afatinib 40 mg or clinical routine dose once daily
Other Names:
Drug: Dacomitinib
Dacomitinib 45mg or clinical routine dose once daily
Other Names:
|
| 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. |
Drug: Bevacizumab
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
Other Names:
Drug: Osimertinib
Osimertinib 80 mg once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1 [This is a real-world study. The estimated median PFS for bevacizumab plus first-generation EGFR-TKIs is 18 months according to previous data.]
To evaluate the efficacy of bevacizumab combined with first-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators
- Progression-free survival (PFS) for bevacizumab plus second-generation EGFR-TKIs by investigator using RECIST v1.1 [This is a real-world study. The estimated median PFS for bevacizumab plus second-generation EGFR-TKIs is 20 months according to previous data.]
To evaluate the efficacy of bevacizumab combined with second-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators.
- Progression-free survival (PFS) for bevacizumab plus third-generation EGFR-TKIs by investigator using RECIST v1.1 [This is a real-world study. The estimated median PFS for bevacizumab plus third-generation EGFR-TKIs is 22 months according to previous data.]
To evaluate the efficacy of bevacizumab combined with third-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators.
Secondary Outcome Measures
- 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.]
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
- 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.]
Disease control rate (DCR) will be analyzed using similar method as objective response rate.
- Overall survival [The primary analysis on overall survival is espected to perform on 48 months of follow-up.]
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.
- 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.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients must meet the following criteria for study entry:
-
Signed Informed Consent Form.
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Age≥18 years.
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Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC), metastatic (Stage IV) or recurrent non-squamous NSCLC.
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An exon 19 deletion mutation or exon 21 L858R mutation in EGFR has been found clinically, with or without EGFR T790M mutation
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Eastern Cooperative Oncology Group performance status 0-2 or KPS ≥60
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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:
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Squamous carcinoma or mixed non-small cell lung cancer with squamous component.
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Potential hazard for receiving EGFR-TKIs or bevacizumab by clinical evaluations
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Previous history of receiving EGFR-TKIs or bevacizumab treatment prior to study enrollment
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Suspected or diagnosed leptomeningeal metastases
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Chest radiotherapy within 3 months prior to study enrollment
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Open surgery within 4 weeks prior to study enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- Guangdong Association of Clinical Trials
Investigators
- Principal Investigator: Qing Zhou, PhD, Guangdong Provincial People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTONG1905