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Kinase Inhibitor

BgRT + SBRT + Osimertinib for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Arya Amini

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) =< 2

The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests how well BgRT and SBRT with osimertinib work to treat EGFR+ lung cancer that has spread from the primary site. BgRT & SBRT target active tumors, osimertinib blocks the protein that signals cancer cells to multiply, potentially killing more tumor cells.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) that has spread to a few sites and have been stable on osimertinib for over 6 months. They must be able to take oral meds, have a life expectancy of at least 6 months, and agree to birth control measures. Excluded are those with certain heart conditions, untreated brain metastases, significant illnesses, or taking drugs that affect the study medication.Check my eligibility

What is being tested?

The trial tests biologically guided radiation therapy (BgRT) combined with stereotactic body radiation therapy (SBRT) and osimertinib in patients whose NSCLC has progressed in limited areas. BgRT targets active tumors during treatment while SBRT delivers precise high-dose radiation to minimize damage to healthy tissue.See study design

What are the potential side effects?

Possible side effects include skin reactions from radiation, fatigue, difficulty swallowing due to throat irritation from the treatments. Osimertinib may cause diarrhea, rash, dry skin or nail changes; less commonly it can affect the lungs causing breathlessness or cough.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can perform daily activities with minimal assistance.

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My tumor has a specific EGFR mutation known to respond to certain treatments.

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My cancer worsened on osimertinib after being stable for 6+ months.

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I have only been treated with osimertinib for my advanced disease.

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I have a lung or bone cancer lesion larger than 2 cm that can be treated with radiation.

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My cancer can be treated with high-dose radiation in short sessions.

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I can swallow and keep down pills.

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My lung cancer is confirmed to be advanced non-small cell type.

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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of patients on planned protocol treatment

Secondary outcome measures

Change in fludeoxyglucose (FDG) uptake

Change in quality of life (QOL)

First occurrence of disease progression

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (BgRT/SBRT)Experimental Treatment6 Interventions

Patients continue to receive osimertinib PO QD in the absence of unacceptable toxicity. Patients undergo BgRT/SBRT every other day for 5 treatments. Patients then continue to receive osimertinib and are monitored via imaging. If additional progression is found, patients may receive additional BgRT/SBRT therapy. Treatment continues in the absence of > 5 sites of progression, unacceptable toxicity, or the stopping of osimertinib for more than 4 weeks. Patients undergo CT scan or PET/CT scan and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Osimertinib

2017

Completed Phase 4

~1010

Positron Emission Tomography

2008

Completed Phase 2

~2240

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,628 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,409 Total Patients Enrolled

Arya AminiPrincipal InvestigatorCity of Hope Medical Center

5 Previous Clinical Trials

286 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 BgRT/SBRT been authorized by the FDA?

"Treatment (BgRT/SBRT) has been assigned a score of 2, as this Phase 2 trial provides some evidence of safety yet lacks any data on efficacy."

Answered by AI

Are new participants welcome to join this experiment?

"Present information from clinicaltrials.gov reveals that this trial is not currently recruiting participants. Initially posted on Christmas Day in 2023, the study was last updated on August 24th of the same year. Despite its current status there are still 4416 other medical trials actively accepting new patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) With Osimertinib for the Treatment of Patients With Oligoprogressive EGFR Positive Non-small Cell Lung Carcinoma

2024. "Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) With Osimertinib for the Treatment of Patients With Oligoprogressive EGFR Positive Non-small Cell Lung Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014827.