Clinical trial NCT05104281: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Bronchial Neoplasms
EGFR Mutation
Osimertinib
Bevacizumab
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: PFS
timeFrame: 30 months
Secondary outcomes:
measure: OS
timeFrame: Up to 48 months
measure: ORR
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital, Qingdao Cancer Hospital
state: Shandong
Study officials:
References: