Osimertinib Combined With Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Metastatic Non-Small Cell Lung Cancer

  • End date
    Jul 31, 2024
  • participants needed
  • sponsor
    Qingdao Central Hospital
Updated on 14 November 2021
measurable disease
growth factor
epidermal growth factor receptor
epidermal growth factor
lung carcinoma
Accepts healthy volunteers


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.


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).

Condition Non-Small Cell Lung Cancer
Treatment Osimertinib Oral Tablet
Clinical Study IdentifierNCT04974879
SponsorQingdao Central Hospital
Last Modified on14 November 2021


Yes No Not Sure

Inclusion Criteria

Participant must have histologically or cytologically confirmed, locally
Participant must have Eastern Cooperative Oncology Group (ECOG) performance
advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with
status 0 or 1, or 2 Participant must agree to genetic characterization of
documented primary epidermal growth factor receptor (EGFR) Exon 20ins
tumor status through the required pretreatment tumor biopsy (or submission of
activating mutation Participant must have measurable disease according to
equivalent archival material), as well as baseline and periodic blood samples
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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