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Tyrosine Kinase Inhibitor
Osimertinib + SRS for Lung Cancer
Phase 2
Recruiting
Led By Cheryl Ho, 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of osimertinib alone to osimertinib with SRS for brain metastases in patients with newly diagnosed EGFR positive lung cancer.
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.Check my eligibility
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.See study design
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.
Select...
My cancer has specific EGFR mutations.
Select...
I am eligible for and agree to follow the treatment plan with osimertinib as my first line of therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial progression free survival
Secondary outcome measures
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
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
Find a Location
Who is running the clinical trial?
Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
38,983 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,550,601 Total Patients Enrolled
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,435 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:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Osimertinib being explored in any other clinical investigations?
"In 2013, the first trial of osimertinib was conducted at Research Site. Since then, 34 studies have been finalized and 101 are still running; many taking place in Toronto, Ontario."
Answered by AI
Has the US Food & Drug Administration given its consent to Osimertinib?
"While preliminary evidence suggests that Osimertinib is secure, there has yet to be any clinical data demonstrating its efficacy. Thus, we rated the drug's safety a 2 on our scale of 1-3."
Answered by AI
Is it currently possible to enroll in this research?
"Affirmative. According to clinicaltrials.gov, this trial that was initially shared on March 19th 2019 is currently open for recruitment and has recently been edited during February 2021. They are seeking 76 volunteers across 3 different locations."
Answered by AI
Is this clinical trial the inaugural foray into its field?
"Osimertinib's journey into medical science began in 2013 when AstraZeneca sponsored its first clinical trial involving 603 participants. Successful Phase 1 & 2 trials followed and now, 101 active studies are being conducted worldwide across 1059 cities and 51 countries."
Answered by AI
What is the total capacity of this clinical experiment?
"Affirmative. Clinicaltrials.gov records that this clinical trial, which was first published on March 19th 2019, is actively recruiting participants. 76 individuals are being sought after from 3 distinct medical centres."
Answered by AI
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