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Tyrosine Kinase Inhibitor

Osimertinib + SABR for Lung Cancer

Phase 2
Waitlist Available
Led By Sawsan Rashdan, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced EGFR exon 19 or 21 mutant NSCLC, not amenable to curative surgery or radiotherapy. EGFR mutations may be demonstrated by standard, clinically accepted methods, including direct gene sequencing, PCR, and NextGen sequencing.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Must not have
Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first study medication dose through treatment period and including the follow-up period every 3 months following last dose of study medication, until subject death from any cause, up to 48 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether adding osimertinib to SABR improves outcomes for people with EGFR-mutant lung cancer.

Who is the study for?
This trial is for adults over 18 with advanced EGFR mutant NSCLC, who can't have surgery or radiotherapy. They should expect to live at least 12 weeks and have good organ function. Participants must not be pregnant, breastfeeding, or planning to get pregnant and agree to use contraception. People with certain heart conditions, uncontrolled diseases, a history of severe lung issues like ILD, or those who've had specific treatments like osimertinib are excluded.
What is being tested?
The study tests the combination of Osimertinib (a drug) and Stereotactic Ablative Radiation (SABR), both known for being well-tolerated in treating non-small cell lung cancer. It aims to evaluate how effective this combo is when used together.
What are the potential side effects?
Possible side effects include skin reactions from radiation, fatigue, coughing up blood due to SABR; diarrhea, rash from Osimertinib; as well as potential impacts on liver enzymes and kidney function which will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer has specific EGFR mutations and cannot be cured with surgery or radiation.
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I can take care of myself and perform daily activities.
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I have a tumor that can be measured with CT or MRI scans and has not been treated with radiation.
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My blood and organ functions meet the required levels for treatment.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lung inflammation or damage that needed steroids.
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I cannot take osimertinib due to severe nausea, vomiting, or issues with my digestive system.
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I have been treated with immunotherapy or checkpoint inhibitors before.
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I have heart issues that could affect my ECG or increase the risk of heart rhythm problems.
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I have been treated with osimertinib or another EGFR inhibitor.
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I have brain metastases causing symptoms and instability.
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I am not pregnant, breastfeeding, or if capable of childbearing, I am using effective birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first study medication dose through treatment period and including the follow-up period every 3 months following last dose of study medication, until subject death from any cause, up to 48 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first study medication dose through treatment period and including the follow-up period every 3 months following last dose of study medication, until subject death from any cause, up to 48 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS)
Secondary study objectives
Determine the impact of Osimertinib plus SABR on length of response
Determine the impact of Osimertinib plus SABR on survival
Determine the impact of Osimertinib plus SABR on the duration of time while on Osimertinib
+3 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
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

1Treatment groups
Experimental Treatment
Group I: OsimertinibExperimental Treatment2 Interventions
Osimertinib in combination with Stereotactic Ablative Radiation (SABR)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1120
SABR
2012
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,642 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,411 Total Patients Enrolled
Sawsan Rashdan, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03667820 — Phase 2
Lung Cancer Research Study Groups: Osimertinib
Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03667820 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03667820 — Phase 2
~6 spots leftby Jan 2026
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