NSCLCBELLANCT04575415
Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study
An observational study of NSCLC, run by Guangdong Association of Clinical Trials at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Bevacizumab, Erlotinib and Gefitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Qing Zhou, PhD, 862081884713 ext. 80611, gzzhouqing@126.com
About this study
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
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.
- Conditions
- NSCLC
- Being tested
- Bevacizumab, Erlotinib, Gefitinib, Icotinib, Afatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
ErlotinibDrug
Also called Tarceva
Erlotinib 150mg, orally once a day
GefitinibDrug
Also called Iressa
Gefitinib 250mg, orally once a day
IcotinibDrug
Also called Conmana
Icotinib 125mg three times a day
AfatinibDrug
Also called Gilotrif
Afatinib 40 mg or clinical routine dose once daily
DacomitinibDrug
Also called Vizimpro
Dacomitinib 45mg or clinical routine dose once daily
OsimertinibDrug
Also called Tagrisso
Osimertinib 80 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab; Drug: Erlotinib; Drug: Gefitinib; Drug: Icotinib | |
| 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. Receives: Drug: Bevacizumab; Drug: Afatinib; Drug: Dacomitinib | |
| 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. Receives: Drug: Bevacizumab; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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
Disease control rate (DCR) will be analyzed using similar method as objective response rate.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start7 Oct 2020
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Zhou, PhD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575415
- Sponsor's protocol ID
- CTONG1905
- Acronym
- BELLA
- Status last verified
- Oct 2020
- First submitted
- 8 Sep 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04575415
- Acronym / sponsor ID
- BELLA / CTONG1905
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib | – | Drug: Bevacizumab, Drug: Erlotinib, Drug: Gefitinib, Drug: IcotinibPatients 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 | – | Drug: Bevacizumab, Drug: Afatinib, Drug: DacomitinibPatients 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 | – | Drug: Bevacizumab, Drug: OsimertinibPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Patients must meet the following criteria for study entry:
Key exclusion criteria (7 listed)
- Patients who meet any of the following criteria will be excluded from study entry:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle | Drug | Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib, Arm 2:Bevacizumab plus Afatinib/Dacomitinib, Arm 3:Bevacizumab plus Osimertinib |
| ErlotinibAlso: TarcevaErlotinib 150mg, orally once a day | Drug | Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib |
| GefitinibAlso: IressaGefitinib 250mg, orally once a day | Drug | Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib |
| IcotinibAlso: ConmanaIcotinib 125mg three times a day | Drug | Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib |
| AfatinibAlso: GilotrifAfatinib 40 mg or clinical routine dose once daily | Drug | Arm 2:Bevacizumab plus Afatinib/Dacomitinib |
| DacomitinibAlso: VizimproDacomitinib 45mg or clinical routine dose once daily | Drug | Arm 2:Bevacizumab plus Afatinib/Dacomitinib |
| OsimertinibAlso: TagrissoOsimertinib 80 mg once daily | Drug | Arm 3:Bevacizumab plus Osimertinib |
Primary outcome
Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Objective response rate (ORR) by investigator using RECIST v1.1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Zhou, PhD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Guangdong Association of Clinical Trials at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Zhou, PhD (862081884713 ext. 80611, gzzhouqing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1 (time frame: This is a real-world study. The estimated median PFS for bevacizumab plus first-generation EGFR-TKIs is 18 months according to previous data.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.