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Tyrosine Kinase Inhibitor

Osimertinib + Bevacizumab for Lung Cancer

Phase 3
Recruiting
Led By Helena A Yu
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
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial is testing whether adding bevacizumab to osimertinib will help patients with EGFR-mutated, stage IIIB-IV non-small cell lung cancer live longer, as compared to osimertinib alone.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread and have specific EGFR gene mutations. They should not have had previous treatments with EGFR TKI or anti-VEGF agents, no major heart issues, and must not be on strong CYP3A4 inducers. Patients can join if they've finished certain radiation therapies before starting the study drugs and if they don't have severe diseases or conditions that could affect their participation.Check my eligibility
What is being tested?
The trial is testing whether adding Bevacizumab to Osimertinib improves outcomes in patients compared to using Osimertinib alone. Both are cancer medications: Osimertinib targets a protein involved in tumor growth, while Bevacizumab may prevent tumors from creating new blood vessels needed for them to grow.See study design
What are the potential side effects?
Osimertinib might cause diarrhea, rash, dry skin, nail changes or mouth sores. Bevacizumab can lead to high blood pressure, bleeding problems, headaches or nosebleeds. When combined there's a risk of more intense side effects due to interactions between the two drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I don't have severe side effects from previous treatments, except for hair loss or mild nerve pain.
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I have not received any systemic treatment for my metastatic disease.
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My lung cancer is non-squamous and confirmed by a pathology test.
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I don't have heart issues or family history that could affect my heart's rhythm.
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My cancer is advanced and cannot be treated with a combination of therapies.
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My cancer has a specific EGFR mutation, not the exon 20 insertion.
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I have not been treated with EGFR or anti-VEGF drugs.
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My hepatitis B virus is under control with treatment.
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My heart's electrical activity is normal, with no significant issues.
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I have never had lung conditions that caused scarring or needed steroids.
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I can take care of myself and am up and about more than half of my waking hours.
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My brain metastases are treated, stable, and I'm not on steroids after a specific waiting period post-treatment.
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I don't have bleeding from the lungs, heart disease, high blood pressure, kidney issues, or tumors in major blood vessels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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
Best objective response rate
Central Nervous System
Incidence of adverse events
+2 more
Other outcome measures
Mechanisms of resistance to AZD9291 (osimertinib) and AZD9291 (osimertinib) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA)
ctDNA clearance on study treatment

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
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
Active Control
Group I: Arm B (osimertinib, bevacizumab)Experimental Treatment7 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 ECHO, MUGA, CT and may undergo MRI and blood sample collection on study.
Group II: Arm A (osimertinib)Active Control6 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 sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
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
13,665 Previous Clinical Trials
40,925,554 Total Patients Enrolled
Helena A YuPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04181060 — Phase 3
Lung Cancer Research Study Groups: Arm A (osimertinib), Arm B (osimertinib, bevacizumab)
Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT04181060 — Phase 3
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04181060 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some similar trials that have used Osimertinib in the past?

"Originally, osimertinib was studied in 2004 at Memoral Sloan Kettering Basking Ridge (Follow Up Only). So far, 1034 studies have been completed. There are currently 478 active clinical trials, many of which are based in Bethesda, Maryland."

Answered by AI

How many candidates will be chosen for this experiment?

"That is correct, the clinicaltrials.gov website does show that this trial is currently enrolling patients. The trial was originally posted on October 22nd, 2020 and was most recently updated on October 27th, 2020. They are hoping to enroll 300 patients from 100 different locations."

Answered by AI

What side effects does Osimertinib have on patients?

"Osimertinib has received a score of 3 for safety. This is due to Phase 3 trial data, which provides some evidence of efficacy as well as multiple rounds of data supporting safety."

Answered by AI

What are the most common applications for Osimertinib?

"Osimertinib can be used to treat aggressive and recurrent cancers such as malignant neoplasms, platinum sensitive primary peritoneal cancer, and stage iv epithelial ovarian cancer."

Answered by AI

Are people with the condition still able to participate in this research?

"That is correct. The clinical trial is currently recruiting patients. The first posting was on October 22, 2020, with the latest update on October 27, 2020. They are looking for 300 patients total from 100 different sites."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I'll do anything that might help me live.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
2020. "Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04181060.
All > Alaska
~133 spots leftby Dec 2026
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