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Lung Cancer Non-small Cell Stage IVPhase 2NCT03769103

Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

A Phase 2 study testing Osimertinib and Stereotactic radiotherapy in people with Lung Cancer Non-small Cell Stage IV and Brain Metastases, run by British Columbia Cancer Agency at 3 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This open-label, multicenter, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Osimertinib and Stereotactic radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesCanada
Study dates
19 Mar 2019to Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent by patient or legally acceptable representative
  • Meets the criteria in the approved regulatory indication for first line treatment with osimertinib and agree to the restrictions, monitoring, and dose-adjustment criteria stipulated in the associated product label
  • Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)
  • No prior systemic therapy except neoadjuvant, adjuvant or concurrent chemotherapy given greater than 3 months prior to enrollment on study
  • Asymptomatic or minimally symptomatic brain metastases (ie. Headache, nausea, or seizure responsive to dexamethasone/analgesic/antiepileptic on stable doses of medications for a minimum of 3 days)
  • Brain metastases must meet the following criteria on a diagnostic MRI: at least one lesion can be classified as measurable disease per RANO-BM, ≤ 10 brain or brainstem metastases, ≤ 30 mm and brainstem metastases must be ≤ 5 mm, metastases > 5 mm from the optic nerve or chiasm
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  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • Willing to abstain from sexual activity or willing to use double-barrier method during sexual intercourse

Who cannot join

  • Previous treatment with osimertinib, or any other EGFR TKI
  • Patient with symptomatic brain metastases causing any neurologic deficit (not including headache, nausea, or medically controlled seizure)
  • Multiple sclerosis
  • Pacemaker or MRI-incompatible metal in the body
  • Allergy to gadolinium MRI contrast
  • Brain metastasis requiring surgery for decompression
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  • Leptomeningeal disease
  • Previous cranial RT, or surgery for brain metastases
  • Uncontrolled systemic lupus erythematosis, scleroderma or other connective tissue disorders considered a contraindication for radiotherapy
  • Active cancer from another anatomical site within 5 years (non-melanomatous skin and cervical cancers permitted)
  • Any medical or non-medical issue that would render patient unable to reliably complete regular QOL and neurocognitive assessments
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
  • Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
  • Patients with symptomatic CNS metastases who are neurologically unstable
  • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
  • Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib
  • Pregnant or breastfeeding

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Princess Margaret Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • BC Cancer, Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: Open Label, Multicenter, Phase II Study of Patients With Treatment Naïve Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases Randomized to Stereotactic Radiosurgery (SRS) and Osimertinib or Osimertinib Alone

This open-label, multicenter, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer.

Being tested
Osimertinib, Stereotactic radiotherapy
Keywords
EGFR positive, Osimertinib, SRS
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsimertinibDrug

    Daily oral osimertinib

  • Stereotactic radiotherapyRadiation

    1-5 fractions of stereotactic radiotherapy

Study groups in NCT03769103
Study groupRoleWhat they receive
SRS + OsimertinibActive comparatorStereotactic 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.
Receives: Drug: Osimertinib; Radiation: Stereotactic radiotherapy
Osimertinib aloneExperimentalOsimertinib 80mg PO daily
Receives: Drug: Osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial progression free survival

    Absence of progressive brain metastases according to the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM criteria)

    Measured: 1 year

Secondary outcomes (9)

  1. Intracranial overall response rate

    partial or complete response to therapy based on RANO-BM criteria

    Measured: 2 years

  2. Time to whole brain radiotherapy (WBRT)

    time from randomization to WBRT

    Measured: 2 years

  3. Time to stereotactic radiosurgery (SRS)

    time from randomization to SRS (not including initial SRS in the SRS + osimertinib treatment arm)

    Measured: 2 years

  4. Rate of radionecrosis

    according to institutional standards based on radiologic findings with or without pathologic confirmation and multidisciplinary review when required

    Measured: 2 years

  5. Overall survival

    defined as time from randomization to death by any cause

    Measured: 2 years

  6. Time to distant progression

    time from randomization to progression of extracranial metastases or development of new sites of disease per RECIST 1.1

    Measured: 2 years

  7. Quality of life

    Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. Subscales for: general presence of symptoms in patients with cancer question 1-28 (1=Not at all; 4=very much); overall health/quality of life question 29-30 (1=very poor; 7=excellent) \& EORTC-QLQ Brain Neoplasm (BN)20: Subscales for presence of symptoms in patients with brain tumours question 31-50 (1=Not at all; 4=very much)

    Measured: 2 years

  8. Neurocognitive function

    Assessed by Montreal Cognitive Assessment. Total score:30. 1=poor function; 30=good function

    Measured: 2 years

  9. Exposure to osimertinib

    Osimertinib dose (40mg or 80mg) for x number of days (max=730 days)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2018
  2. Study start19 Mar 2019
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03769103
Sponsor's protocol ID
LUOSICNS
Status last verified
Oct 2024
First submitted
3 Dec 2018
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee CK, Lefresne S, Soon YY, Robledo K, Nichol A, Sahgal A, Pinkham MB, Melosky B, Huang Y, McDermott R, Tham IWK, Parmar A, Tey JCS, Liu M, Solomon BJ, Sacher A, Leong CN, Laskin J, Koh WY, Menjak IB, Ang Y, Shultz DB, Low JL, Doherty M, Yong C, Lim MC, Tan AP, Soo RA, Hegi-Johnson F, Ho C. Osimertinib and Stereotactic Radiosurgery for Brain Metastases in EGFR-Mutated Lung Cancer: The STARLET Joint Analysis of OUTRUN and LUOSICNS Randomized Trials. J Thorac Oncol. 2026 May;21(5):103549. doi: 10.1016/j.jtho.2026.01.001. Epub 2026 Jan 12.

    PubMed 41534788

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Osimertinib and Stereotactic radiotherapy in people with Lung Cancer Non-small Cell Stage IV and Brain Metastases, run by British Columbia Cancer Agency at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial progression free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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