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Tyrosine Kinase Inhibitor

Osimertinib + SRS for Lung Cancer

Phase 2
Waitlist Available
Led By Shilo V Lefresne, MD, FRCPC
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)
Must not have
Patients with symptomatic CNS metastases who are neurologically unstable
Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing osimertinib alone and with precise radiation therapy in patients with a specific type of lung cancer that has spread to the brain. Osimertinib blocks a protein that helps cancer grow, while the radiation therapy targets brain tumors with focused radiation.

Who is the study for?
This trial is for adults with a specific lung cancer (NSCLC) that has spread to the brain, who have not had prior treatment and whose cancer cells show certain mutations (EGFR). Participants must be in stable condition, able to follow study procedures, and willing to use effective contraception. Those with other active cancers, severe brain symptoms, or conditions affecting study participation are excluded.
What is being tested?
The study compares two approaches: one group receives Osimertinib alone while the other gets Osimertinib plus Stereotactic RadioSurgery (SRS), which is a precise radiation therapy. This phase II trial aims to determine if adding SRS improves outcomes for patients with brain metastases from NSCLC.
What are the potential side effects?
Osimertinib may cause diarrhea, rash, dry skin, nail changes and mouth sores. Rarely it can affect heart rhythm or cause lung problems. SRS might lead to headaches or fatigue shortly after treatment; long-term effects include potential memory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My cancer has specific EGFR mutations.
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I am eligible for and agree to follow the treatment plan with osimertinib as my first line of therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases causing symptoms and affecting my neurological stability.
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I am not taking any medication that affects my heart's rhythm.
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I have been diagnosed with multiple sclerosis.
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I have brain metastases causing symptoms other than headache, nausea, or controlled seizures.
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I have had brain surgery or radiation for brain metastases.
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I do not have uncontrolled lupus, scleroderma, or similar conditions that would prevent radiotherapy.
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My cancer has spread to the lining of my brain and spinal cord.
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I am not taking, nor can I stop taking, drugs or supplements that affect liver enzyme CYP3A4.
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I need surgery to relieve pressure in my brain from cancer spread.
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I haven't taken any experimental drugs recently.
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I have been treated with osimertinib or another EGFR inhibitor.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intracranial progression free survival
Secondary study objectives
Exposure to osimertinib
Intracranial overall response rate
Neurocognitive function
+6 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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Osimertinib aloneExperimental Treatment1 Intervention
Osimertinib 80mg PO daily
Group II: SRS + OsimertinibActive Control2 Interventions
Stereotactic radiotherapy will be delivered in 1-5 fractions to each brain metastases according to the volume and location of the metastases and clinician discretion. Osimertinib will start 1-7 days post radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include EGFR Tyrosine Kinase Inhibitors (TKIs) like Osimertinib, chemotherapy, and immunotherapy. Osimertinib targets and inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase, which is often mutated in NSCLC, thereby blocking the signaling pathways that promote cancer cell growth and survival. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy, such as pembrolizumab, enhances the body's immune response against cancer cells by targeting immune checkpoints. These treatments are crucial for NSCLC patients as they offer targeted and systemic approaches to control and potentially eradicate the cancer, improving survival rates and quality of life.
An overview of osimertinib as a treatment of non-small cell lung cancer (NSCLC): an update.

Find a Location

Who is running the clinical trial?

Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
39,028 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
680 Previous Clinical Trials
1,565,826 Total Patients Enrolled
British Columbia Cancer AgencyLead Sponsor
175 Previous Clinical Trials
94,188 Total Patients Enrolled

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03769103 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: SRS + Osimertinib, Osimertinib alone
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03769103 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769103 — Phase 2
~2 spots leftby Apr 2025