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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

Must not have

Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease

History of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I can take care of myself but might not be able to do heavy physical work.

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My lung cancer has a specific change in the EGFR gene.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung conditions that needed steroid treatment.

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I am allergic to osimertinib or similar drugs.

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I do not have any other active cancers besides the one being studied, except for skin cancer.

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I cannot take osimertinib due to severe nausea, vomiting, or other digestive issues.

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I have been treated with an EGFR inhibitor before.

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I have previously been treated with medications targeting blood vessel growth.

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My urine protein levels are below 1000 mg in a 24-hour test.

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I have a serious or non-healing wound, ulcer, or bone fracture.

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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.

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My heart health meets the study's requirements.

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I do not have bleeding disorders or significant coughing up of blood.

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I have brain metastases and surgery to remove them is considered suitable for me.

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I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.

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I do not have any major heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence of adverse events

Intracranial response

Intracranial response rate

+5 more

Other study objectives

Angiogenic signature assessed in plasma by multiplex panel array

Biomarker analysis of angiogenesis and signaling pathways

Changes in the tumor immune microenvironment

+2 more

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.

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

~5540

Biopsy

2014

Completed Phase 4

~1090