Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    60
  • sponsor
    Qingdao Central Hospital
Updated on 11 November 2021
measurable disease
growth factor
metastasis
epidermal growth factor receptor
EGFR
bevacizumab
epidermal growth factor
osimertinib
lung carcinoma

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.

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).

Details
Condition Non-Small Cell Lung Cancer
Treatment osimertinib oral and bevazizumab intravenously
Clinical Study IdentifierNCT05104281
SponsorQingdao Central Hospital
Last Modified on11 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must have histologically or cytologically confirmed, metastatic
Participant must have Eastern Cooperative Oncology Group (ECOG) performance
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
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
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