At a glance
ClinicalIndex Comparison Record- ✓Pathologically-confirmed non-squamous, non-small cell lung cancer (NSCLC)
- ✓Advanced disease: stage IV, stage IIIB not amenable to multimodality therapy, or recurrent disease after stage I-III
- ✓Somatic activating sensitizing EGFR mutation (Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I)
- ✓Age ≥18 years
- ✕Non-sensitizing EGFR mutations (EGFR exon 20 insertions)
- ✕Prior anti-VEGF agent treatment
- ✕Prior EGFR TKI treatment (except osimertinib within 21 days if baseline imaging done before start)
- ✕Risk factors for anti-VEGF: hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria >300 mg/dl, tumor invading major blood vessels
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
In Brief
A Phase 3 clinical trial evaluating Bevacizumab, Biospecimen Collection, and 5 other interventions for Advanced Lung Non-Squamous Non-Small Cell Carcinoma and 4 related conditions. Currently recruiting, targeting 300 participants across 603 sites.
Detailed Summary
This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
Study Details
Timeline
Arms & Interventions
Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, MUGA, CT and may undergo MRI and blood and urine sample collection on study.
Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, MUGA, CT and may undergo MRI and blood and urine sample collection on study.
Interventions
Given IV
Undergo blood and urine sample collection
Undergo CT
Undergo ECHO
Undergo MRI
Undergo MUGA
Given PO