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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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Best objective response rate
Central Nervous System
Incidence of adverse events
+2 more
Other study objectives
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
Biospecimen Collection
2004
Completed Phase 3
~2020
Bevacizumab
2013
Completed Phase 4
~5540
Echocardiography
2013
Completed Phase 4
~11580
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Osimertinib
2017
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,700 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
~112 spots leftby Dec 2026
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