The purpose of this study is to investigate the safety and efficacy of giving atezolizumab combined with bevacizumab in patients with stage 4 epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) whose cancer has gotten worse while receiving osimertinib.
This study will be single arm, open label, phase 2 study which will include patients with stage 4 NSCLC patients with EGFR mutations and who have progressed on osimertinib. Although both atezolizumab and bevacizumab are approved for the treatment of NSCLC, the combination of atezolizumab and bevacizumab has not been approved by the FDA for the treatment of specific non-small cell lung cancer (NSCLC). Patients who have one of the following EGRF mutations: exon 19 or exon 21 L858R with progressive disease on osimertinib may be eligible to participate in this study. If enrolled into the study, the study team will give the patient atezolizumab (1200 mg) combined with bevacizumab (15 mg/kg) every 3 weeks intravenously. As part of this study, the patient will have blood samples, other tests, exams, and procedures done for study purposes and their standard of care. Patient participation in the study will last for up to 2 years after completion of the last dose of the study drug or until your condition worsens or intolerable adverse events as deemed by the study doctor. There are possible patient risks to this study that include but are not limited to diarrhea, itching, rash, and a feeling of weakness.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
1200 mg IV every 3 weeks
15 mg/kg IV every 3 weeks
Duke University Medical Center
Durham, North Carolina, United States
Objective Response Assessed by the Investigator Using RECIST 1.1
Objective response (complete or partial response) rate (ORR) is assessed by the investigator using Response Evaluation Criteria in Solid Tumors RECIST 1.1 (brand name) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 2 years
Progression Free Survival as Measured by RECIST v1.1 RECIST 1.1 (Brand Name) as Assessed by the Investigator.
Progression will be defined as time from start of study therapy to disease progression or death whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median survival time and its 95% CI will be calculated.
Time frame: Up to 2 years
Overall Survival as Noted by Follow-up Via Composite of Telephone or Medical Record Review.
Overall survival (OS) is defined as the time from start of study therapy to death from any cause, and patients who are alive at the time of analysis will be censored at the last date of contact.
Time frame: Up to 2 years
Number of Participants With AEs as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
All patients who receive at least one dose of study treatment will be included in the safety analysis. The frequencies and percentage of treatment-related adverse events will be tabulated.
Time frame: Up to 2 years
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