Back to resultsOsimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
osimertinib oral and bevazizumab intravenously
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Bronchial Neoplasms, EGFR Mutation, Osimertinib, Bevacizumab
Eligibility Criteria
Inclusion Criteria:
Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.
Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2.
Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Exclusion Criteria:
Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
Participant has a contraindication to the use Osimertinib or Bevacizumab.
Sites / Locations
- Qingdao Central Hospital, Qingdao Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study drug
Arm Description
osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days
Outcomes
Primary Outcome Measures
PFS
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Secondary Outcome Measures
OS
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
ORR
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
Full Information
NCT ID
NCT05104281
First Posted
October 21, 2021
Last Updated
March 27, 2023
Sponsor
Qingdao Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05104281
Brief Title
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
Official Title
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qingdao Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation.
Detailed Description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that osimertinib combined bevacizumab in patients with advanced NSCLC patients with brain metastasis characterized by EGFR mutations . Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Bronchial Neoplasms, EGFR Mutation, Osimertinib, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study drug
Arm Type
Experimental
Arm Description
osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days
Intervention Type
Drug
Intervention Name(s)
osimertinib oral and bevazizumab intravenously
Other Intervention Name(s)
bevacizumab, osimertinib
Intervention Description
osimertinib 80mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days.
Primary Outcome Measure Information:
Title
PFS
Description
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame
30 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
Time Frame
Up to 48 months
Title
ORR
Description
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
Time Frame
Up to 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.
Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2.
Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Exclusion Criteria:
Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
Participant has a contraindication to the use Osimertinib or Bevacizumab.
Facility Information:
Facility Name
Qingdao Central Hospital, Qingdao Cancer Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
youxin ji, M.D.
Phone
8653268665078
Email
mdji001@gmail.com
First Name & Middle Initial & Last Name & Degree
chunling zhang, M.D.
First Name & Middle Initial & Last Name & Degree
youxin ji, M.D.
First Name & Middle Initial & Last Name & Degree
Keke Nie, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
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