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Tyrosine Kinase Inhibitor
Osimertinib +/− Bevacizumab for Lung Cancer with Brain Metastasis
Phase 2
Waitlist Available
Led By Sarah B Goldberg
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Non-small cell lung cancer (NSCLC) with an activating EGFR mutation (exon 19 deletion, L858R point mutation, or any other mutation known to be associated with EGFR TKI sensitivity); presence of an activating EGFR mutation may be documented in tumor tissue or by plasma testing if performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying osimertinib with or without bevacizumab for patients with EGFR positive non-small cell lung cancer that has spread to the brain.
Who is the study for?
This trial is for adults with non-small cell lung cancer that has an EGFR mutation and spread to the brain. They should have a life expectancy over 3 months, be willing to use contraception, and not be breastfeeding or pregnant. No prior EGFR TKI treatment or immunotherapy is allowed, and they mustn't have symptomatic brain metastases or other active cancers.Check my eligibility
What is being tested?
The study tests if osimertinib alone or combined with bevacizumab is more effective for patients whose lung cancer has spread to the brain. Osimertinib blocks enzymes needed by tumor cells; bevacizumab may prevent tumor growth by inhibiting blood vessel formation.See study design
What are the potential side effects?
Osimertinib can cause diarrhea, rash, dry skin, nail changes, mouth sores, reduced appetite and fatigue. Bevacizumab might lead to high blood pressure, bleeding problems, slow wound healing and could increase the risk of developing holes in your stomach/intestines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My lung cancer has a specific change in the EGFR gene.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Brain metastasis response rate
Incidence of adverse events
Intracranial response
+7 moreOther outcome measures
Angiogenic signature assessed in plasma by multiplex panel array
Biomarker analysis of angiogenesis and signaling pathways
Changes in the tumor immune microenvironment
+2 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (osimertinib)Experimental Treatment1 Intervention
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 CT scan, MRI, tumor biopsy and blood sample collection throughout the study.
Group II: Arm I (osimertinib, bevacizumab)Experimental Treatment6 Interventions
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 CT scan, MRI, tumor biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,041 Total Patients Enrolled
Sarah B GoldbergPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung conditions that needed steroid treatment.You are allergic to Chinese hamster ovary cell products or other genetically engineered human antibodies.I am allergic to osimertinib or similar drugs.I do not have any other active cancers besides the one being studied, except for skin cancer.I cannot take osimertinib due to severe nausea, vomiting, or other digestive issues.I can take care of myself but might not be able to do heavy physical work.I have been treated with an EGFR inhibitor before.I have previously been treated with medications targeting blood vessel growth.You cannot have an MRI scan if you have a pacemaker or other metal implant in your body.My urine protein levels are below 1000 mg in a 24-hour test.I have a serious or non-healing wound, ulcer, or bone fracture.I have not undergone any major surgeries recently.My lung cancer has a specific change in the EGFR gene.My cancer can be measured by scans or physical exams, but it's not a must.I am 18 years old or older.I have brain metastases or leptomeningeal disease but no symptoms.I am not currently in any clinical trials and haven't been in one for at least 3 months or five half-lives of the investigational compound, whichever is longer.My heart health meets the study's requirements.I do not have bleeding disorders or significant coughing up of blood.I am not taking, and can stop taking, any strong CYP3A4 inducers 3 weeks before starting the study treatment.I am not pregnant, not breastfeeding, and if I can have children, I use effective birth control.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.I haven't used steroids for brain swelling or neurological symptoms for at least 3 days.I have a brain lesion larger than 5mm that hasn't been treated and doesn't need immediate treatment.I agree to use birth control during and after my treatment.I've been on a stable dose of anti-seizure medication without seizures for at least 2 weeks.I have brain metastases and surgery to remove them is considered suitable for me.I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.You are expected to live for more than 3 months.You have had allergic reactions to drugs similar to osimertinib or bevacizumab.I do not have any major heart problems.I have not been treated with EGFR TKI, but may have had chemotherapy. I haven't had immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (osimertinib, bevacizumab)
- Group 2: Arm II (osimertinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any analogous experiments involving Osimertinib?
"Currently, there are 450 trials exploring the effects of Osimertinib with 104 of them being in Phase 3. Many are concentrated around Taibei, Taiwan; however, it is being studied at over 21000 different locations world wide."
Answered by AI
What is the current enrollment capacity for this experiment?
"At this point, the trial is not actively recruiting. It was first created on June 23rd 2017 and modified as recently as July 2nd 2022. For those seeking alternatives, there are 3946 clinical trials for carcinoma non-small cell lung cancer as well as 450 studies searching for Osimertinib participants currently accepting enrolment."
Answered by AI
How does Osimertinib fare in terms of patient safety?
"The current level of safety data on osimertinib is assessed at 2, as the trial has reached Phase 2 but efficacy hasn't been fully established."
Answered by AI
Are there still sign-up opportunities for this research project?
"As evidenced by clinicaltrials.gov, the recruitment process for this medical study has ended; initial posting was June 23rd 2017 and it was last updated on July 2nd 2022. Despite the conclusion of this trial's participant search, there are currently 4396 other trials that remain eager to find subjects for their research."
Answered by AI
What diseases is Osimertinib typically employed to address?
"Primarily used to treat and manage malignant neoplasms, osimertinib has been successfully deployed in cases of recurrent platinum sensitive primary peritoneal cancer, stage IV epithelial ovarian cancer post-surgical resection, and locally advanced nonsquamous non-small cell lung cancers."
Answered by AI
How widespread is the implementation of this experiment?
"This study is seeking participants at Ohio State University Comprehensive Cancer Center in Columbus, Ohio, Yale University in New Haven, Connecticut and Nebraska Medicine-Bellevue in Bellevue. Additionally there are 18 other potential sites that can be found on the trial's website."
Answered by AI
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