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Tyrosine Kinase Inhibitor

Osimertinib + SRS for Lung Cancer with Brain Metastases

Phase 1

Waitlist Available

Led By Glen Stevens, DO, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is investigating whether a new medication can help control brain metastases in patients with a specific type of lung cancer.

Who is the study for?

This trial is for adults with EGFR mutation positive NSCLC who have new brain metastases. They must be able to care for themselves, walk half the day, and meet specific blood test criteria. Women of childbearing age need a negative pregnancy test and all participants must use effective contraception. Exclusions include certain pre-existing conditions like lung disease or heart problems, use of strong CYP3A inhibitors or inducers, and inability to undergo MRI.Check my eligibility

What is being tested?

The study tests Osimertinib combined with Stereotactic Radiosurgery (SRS) in controlling brain metastases from non-small cell lung cancer (NSCLC). It aims to see if this treatment can manage tumors effectively in patients whose cancer has spread to the brain.See study design

What are the potential side effects?

Osimertinib may cause side effects such as diarrhea, rash, dry skin, nail changes, mouth sores; less commonly it can affect the lungs causing breathlessness or coughing. SRS might lead to headaches, swelling at treatment site or short-term hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

Maximum Tolerated Dose (MTD) of Osimertinib with (SRS)

Secondary outcome measures

Difference in outcome vs. standard of care

Intra-cranial and Extra-cranial Overall Response Rate (ORR)

Length of overall survival

+1 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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Maximum Tolerated Dose of Osimertinib with standard of careExperimental Treatment1 Intervention

For patients with 1-10 brain metastases, begin daily Osimeritinib 0-7 days prior to stereotactic radiosurgery (SRS), provide daily Osimeritinib concurrently with radiotherapy, followed by maintenance Osimeritinib until disease progression, withdrawal, or unacceptable toxicity. Dose Level 1: 80mg daily. Dose Level -1: 40mg daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,904 Total Patients Enrolled

Glen Stevens, DO, PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

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

Has Osimertinib been given the stamp of approval from the Food and Drug Administration?

"The safety of Osimertinib has been rated a 1 on the scale from 1 to 3 due to limited clinical data regarding its efficacy and safety, as this is currently in Phase 1."

Answered by AI

Is enrollment still taking place in this clinical trial?

"This research trial, which commenced on October 26th 2018 and has been recently updated in November 8th 2022, is no longer seeking to recruit participants. However, 2530 other studies that are currently active can be found listed at the same website."

Answered by AI

How many individuals may participate in this experiment?

"Unfortunately, this trial is not presently enrolling patients. Its initial posting was on October 26th 2018 and the latest update occurred on November 8th 2022. For other options, 2429 clinical trials for lung cancer are actively recruiting as well as 101 studies for Osimertinib."

Answered by AI

To what extent has Osimertinib been investigated in the past?

"Osimertinib first appeared in the medical literature in 2013. Since then, 30 trials have been concluded and there are now 101 active research projects being conducted at several locations with Cleveland, Ohio as a central hub for those studies."

Answered by AI

Has this type of experiment been attempted before?

"Osimertinib has been the focus of clinical examination since 2013, when a trial sponsored by AstraZeneca was released. After its positive Phase 1 & 2 results in 2013, it received drug approval and currently there are over one-hundred studies for this medication taking place across 1059 cities and 51 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC

2018. "Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03535363.