Atezolizumab and Bevacizumab in Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer in Patients With Progressive Disease After Receiving Osimertinib
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|ClinicalTrials.gov Identifier: NCT04099836|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : July 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Atezolizumab Drug: Bevacizumab||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm Phase 2 Trial of Atezolizumab and Bevacizumab in Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer in Patients With Progressive Disease After Receiving Osimertinib (TOP 1901)|
|Actual Study Start Date :||July 9, 2020|
|Estimated Primary Completion Date :||November 10, 2023|
|Estimated Study Completion Date :||November 10, 2025|
Experimental: atezolizumab and bevacizumab
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
1200 mg IV
15 mg/kg IV
- Objective response rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors RECIST 1.1 (brand name) [ Time Frame: Up to 3 years ]RECIST 1.1 will be used to measure confirmed partial or complete responses to the study drug.
- Progression free survival as measured by Response Evaluation Criteria In Solid Tumors RECIST 1.1 (brand name) as assessed by the investigator. [ Time Frame: Up to 5 years ]Progression will be defined as time from start of study therapy to disease progression or death
- Overall survival as noted by follow-up via composite of telephone or medical record review. [ Time Frame: Up to 3 years ]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.
- AEs as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 5 years] ]Evaluation of safety using the National Cancer Institute (NCI) CTCAE version 4.03
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099836
|Contact: Carol Alonsofirstname.lastname@example.org|
|Contact: Debra Shoemaker||919-687-4768||Debra.email@example.com|
|Principal Investigator:||Thomas Stinchcombe, MD||Duke University|