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.
PRIMARY OBJECTIVE: I. To evaluate progression-free survival (PFS) of osimertinib (AZD9291) and bevacizumab versus osimertinib (AZD9291) alone as first-line treatment for patients with metastatic EGFR-mutant lung cancers. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS). II. To evaluate best objective response rate and duration of objective response. III. To evaluate time to central nervous system (CNS) progression and CNS PFS. IV. To evaluate toxicity of the combination regimen. CORRELATIVE OBJECTIVES: I. To characterize mechanisms of resistance to osimertinib (AZD9291) and osimertinib (AZD9291) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA). II. To assess for ctDNA clearance on study treatment and associate ctDNA clearance with clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive osimertinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive osimertinib PO QD on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO), multigated acquisition scan (MUGA), computed tomography (CT) and may undergo magnetic resonance imaging (MRI) and blood and urine sample collection on study. After completion of study treatment, patients are followed up every 3 months for 10 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Given IV
Undergo blood and urine sample collection
Undergo CT
Undergo ECHO
Undergo MRI
Undergo MUGA
Given PO
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
SUSPENDEDAnchorage Radiation Therapy Center
Anchorage, Alaska, United States
SUSPENDEDAlaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
SUSPENDEDAlaska Oncology and Hematology LLC
Anchorage, Alaska, United States
RECRUITINGProgression-free survival (PFS)
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. PFS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%.
Time frame: From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years
Overall survival (OS)
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. OS will be tested at the one-sided 10% level.
Time frame: From randomization to death from any cause, assessed up to 10 years
Best objective response rate
Best objective response will be evaluated via RECIST 1.1 criteria. Will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
Time frame: Up to 10 years
Time to central nervous system progression
Will be estimated using competing risks methodology, adjusting for death and progression as competing events. Regular central nervous system imaging will occur when patients are on treatment. After they discontinue study treatment, central nervous system imaging will be symptom-prompted during follow up.
Time frame: From study randomization to evidence of central nervous system progressive disease, with death and progression as competing events, assessed up to 10 years
Central nervous system progression-free survival
Will be estimated using the Kaplan-Meier method.
Time frame: From study randomization to evidence of central nervous system progressive disease or death from any cause, whichever occurs first, assessed up to 10 years
Incidence of adverse events
Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE). Will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
Time frame: Up to 30 days after the last administration of investigational agent
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Alaska Women's Cancer Care
Anchorage, Alaska, United States
SUSPENDEDAnchorage Oncology Centre
Anchorage, Alaska, United States
SUSPENDEDKatmai Oncology Group
Anchorage, Alaska, United States
RECRUITINGProvidence Alaska Medical Center
Anchorage, Alaska, United States
SUSPENDEDFairbanks Memorial Hospital
Fairbanks, Alaska, United States
RECRUITINGCancer Center at Saint Joseph's
Phoenix, Arizona, United States
RECRUITING...and 593 more locations