Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Bronchial Neoplasms, EGFR Mutation, Osimertinib, Bevacizumab
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).
Interventions
DRUGosimertinib oral and bevazizumab intravenously
osimertinib 80mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days.
Sponsors
Qingdao Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 30 months | Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Up to 48 months | Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. |
| ORR | Up to 48 months | 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. |
Countries
China
Outcome results
None listed