Overview
There is no muture method to treat EGFR 20 insertion mutation non-small-cell lung cancer (NSCLC). the he purpose of this study is to study osimertinib combined with bevacizumab in the management of it.
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 locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins activating 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).
Eligibility
Inclusion Criteria:
Participant must have histologically or cytologically confirmed, locally advanced or
metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary
epidermal growth factor receptor (EGFR) Exon 20ins activating mutation 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