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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qingdao Central Hospital
• Treatments: Osimertinib

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.