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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

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

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

Circulating tumor deoxyribonucleic acid (ctDNA) clearance on study treatment

Mechanisms of resistance to AZD9291 (osimertinib) and AZD9291 (osimertinib) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA)

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551

10%

Blood creatine phosphokinase increased

10%

Fatigue

Decreased appetite

Diarrhoea

Cough

Mucosal inflammation

Rash

Pain in extremity

Constipation

Thrombocytopenia

Paronychia

Dyspnoea

Dengue fever

Disease progression

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 and urine 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 and urine sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Biospecimen Collection

2004

Completed Phase 3

~2020