Clinical trial · Interventional
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
NCT05104281CI-TRIAL-00065140unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| osimertinib oral and bevazizumab intravenously | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- study drug
- description
- osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days
- interventionNames
- Drug: osimertinib oral and bevazizumab intravenously
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 30 months
- description
- Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Secondary outcomes (2)
- measure
- OS
- timeFrame
- Up to 48 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZhang L, You Y, Liu X, Liu F, Nie K, Ji Y. Osimertinib combined with bevacizumab as the first-line treatment in non-small cell lung cancer patients with brain metastasis harboring epidermal growth factor receptor mutations. Thorac Cancer. 2023 May;14(15):1355-1361. doi: 10.1111/1759-7714.14880. Epub 2023 Apr 5. PMID 37016906