Osimertinib + SRS for Lung Cancer

Recruiting at 2 trial locations

Overseen By Cheryl Ho, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: British Columbia Cancer Agency

Must be taking: Osimertinib

Must not be taking: CYP3A4 inducers, QT prolonging drugs

Disqualifiers: Multiple sclerosis, Pacemaker, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cheryl Ho, MD

Principal Investigator

BC Cancer, Vancouver Centre

Shilo Lefresne, MD

Principal Investigator

BC Cancer, Vancouver Centre

Eligibility Criteria

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.

Inclusion Criteria

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.

My cancer has specific EGFR mutations.

Exclusion Criteria

I have brain metastases causing symptoms and affecting my neurological stability.

Pregnant or breastfeeding

You are allergic to the contrast dye used in MRI scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Osimertinib alone or SRS followed by Osimertinib for brain metastases

1 year

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Osimertinib
• Stereotactic Radiotherapy

Trial Overview 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.

Participant Groups

Group I: Osimertinib alone Experimental Treatment 1 Intervention

Osimertinib 80mg PO daily

Group II: SRS + Osimertinib Active Control 2 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.

Osimertinib is already approved in United States, European Union for the following indications:

Approved in United States as Tagrisso for:

• Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
• Metastatic EGFR T790M mutation-positive NSCLC

Approved in European Union as Tagrisso for:

• Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
• Metastatic EGFR T790M mutation-positive NSCLC

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology