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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.

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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.

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

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

Primary outcome measures

Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS)

Secondary outcome measures

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

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: 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

~1010

SABR

2013

Completed Phase 2

~70

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,758 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,745 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

Non-Small Cell Lung Cancer Research Study Groups: Osimertinib

Non-Small Cell 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

Frequently Asked Questions

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

What hazards may be associated with the usage of Osimertinib?

"On our safety rating scale, osimertinib scored a 2 due to the limited evidence of efficacy we have so far in Phase 2 trials."

Answered by AI

Does this experimental protocol set a precedent for future research?

"Presently, 101 live clinical studies for Osimertinib exist in 1059 cities and 51 countries. This drug was initially proposed by AstraZeneca in 2013 with a Phase 1 & 2 trial involving 603 patients. Since then, 31 investigations have been concluded."

Answered by AI

How much participation is this research initiative recruiting?

"At this time, no more participants are being sought for this medical trial which began on September 26th 2018 and was last updated May 13th 2022. If you seek other studies, 1912 investigations involving non-small cell lung carcinoma presently have open enrolment slots with 101 trials focusing on osimertinib doing the same."

Answered by AI

Could I potentially qualify to take part in the research project?

"This medical trial is open to 41 individuals betwixt the age of 18 and 99 who have been diagnosed with non-small cell lung carcinoma. In addition, eligible participants must meet a variety of criteria including being male and willing to use contraception, having a WHO/ECOG performance status rating between 0-2, exhibiting good compliance towards the protocol's requirements such as follow up visits and examinations, possessing an expectation for life that exceeds 12 weeks in duration, post-menopausal state (for women aged 50+ or amenorrhea due to cessation of hormone treatments), along with documentation affirming surgical sterilisation through hysterectomy"

Answered by AI

Are there still opportunities for individuals to join this trial?

"According to clinicaltrials.gov this particular research initiative, which was initially posted on September 26th 2018, is no longer enrolling patients at the moment. Nonetheless, there are presently 2013 other trials actively seeking participants for their studies."

Answered by AI

Are there any other exploratory tests that have been conducted using Osimertinib?

"Presently, there are 101 active trials analyzing the effectiveness of Osimertinib with 17 studies in Stage 3. 4702 sites globally have clinical research dedicated to Osimertinib, including some medical centres located in Uniondale, New york."

Answered by AI

Is the age restriction for this research limited to individuals who are under forty years old?

"According to the eligibility requirements of this study, participants should be within the age range 18-99. Separately, there are 44 trials available for minors and 2006 studies open to seniors aged 65 or more."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC

Sawsan Rashdan 2018. "Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03667820.

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