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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Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases causing symptoms and affecting my neurological stability.You are allergic to the contrast dye used in MRI scans.I am not taking any medication that affects my heart's rhythm.You have a pacemaker or metal in your body that is not safe for MRI scans.I have been diagnosed with multiple sclerosis.I can take care of myself and perform daily activities.If you have brain metastases, they must meet certain conditions when checked with an MRI.I have brain metastases causing symptoms other than headache, nausea, or controlled seizures.I have had brain surgery or radiation for brain metastases.I do not have uncontrolled lupus, scleroderma, or similar conditions that would prevent radiotherapy.My cancer has specific EGFR mutations.My cancer has spread to the lining of my brain and spinal cord.I am not taking, nor can I stop taking, drugs or supplements that affect liver enzyme CYP3A4.You are expected to live for more than 6 months.I need surgery to relieve pressure in my brain from cancer spread.I haven't had active cancer from another site in the past 5 years, except for skin or cervical cancer.My brain metastases cause minor symptoms or none, and are controlled with stable medication.I haven't taken any experimental drugs recently.I am willing to not have sex or use double protection during the trial.I have been treated with osimertinib or another EGFR inhibitor.I am eligible for and agree to follow the treatment plan with osimertinib as my first line of therapy.I haven't had systemic therapy for my condition in the last 3 months, except for specific types of chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: SRS + Osimertinib
- Group 2: Osimertinib alone
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.