← Back to Search

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

Must not have

Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection

Diagnosis of congenital long QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I can perform daily activities with minimal assistance.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I can swallow and keep down pills.

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I have a history of HIV or hepatitis B/C.

Select...

I have been diagnosed with congenital long QT syndrome.

Select...

I have severe heart issues, recent heart attack, irregular heartbeat, or signs of poor blood flow on an ECG.

Select...

I have or had lung inflammation that needed steroids.

Select...

I am not taking medication that affects my heart's rhythm.

Select...

I do not have any uncontrolled serious illnesses.

Select...

I have a condition that affects how my body absorbs nutrients.

Select...

I am currently on antibiotics for an infection.

Select...

I am not pregnant or breastfeeding.

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

Percent of patients on planned protocol treatment

Secondary study objectives

Change in fludeoxyglucose (FDG) uptake

Change in quality of life (QOL)

First occurrence of disease progression

+3 more

Awards & Highlights

No Placebo-Only Group

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

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 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790