Osimertinib + SRS for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether osimertinib, a medication, is more effective alone or combined with precise radiation therapy (SRS) for individuals with a specific type of lung cancer that has spread to the brain. Researchers aim to determine which approach better controls cancer cell spread in patients with a certain lung cancer mutation. Individuals who have not received other lung cancer treatments and have brain symptoms manageable with medication might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
You may need to stop taking certain medications before joining the trial, especially if they are known to affect liver enzymes (CYP3A4) or prolong the QT interval (a heart rhythm measure). It's best to discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that osimertinib is both effective and well-tolerated. Patients with certain lung cancer mutations often experience good results with manageable side effects. Research indicates that adding chemotherapy to osimertinib can delay cancer progression compared to using osimertinib alone.
Stereotactic radiotherapy, another treatment in this trial, has also been generally well-received. While most people tolerate it well, about 10% to 30% may experience more serious side effects. These treatments have undergone thorough study, and results suggest they are safe for many people.
Consult a doctor about potential risks and benefits before joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a potentially more effective approach to tackling lung cancer with brain metastases. Unlike standard treatments such as chemotherapy or whole-brain radiation therapy, the combination of Osimertinib and stereotactic radiotherapy (SRS) targets cancer cells more precisely. Osimertinib is a targeted therapy that specifically inhibits the activity of mutated EGFR, which is often present in lung cancer cells. This allows for more focused treatment, reducing damage to healthy cells. Additionally, starting Osimertinib shortly after SRS might enhance its effectiveness, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that osimertinib works well for patients with EGFR-positive lung cancer. In one study, patients taking osimertinib lived for about 20 months without their cancer worsening. Another study found that 84% of patients treated with osimertinib were still alive after three years. In this trial, some participants will receive osimertinib alone, while others will receive a combination of osimertinib and stereotactic radiotherapy (SRS). SRS has also proven effective, with over 90% success in stopping cancer growth in the treated area. Both treatments have shown promising results in managing lung cancer.26789
Who Is on the Research Team?
Cheryl Ho, MD
Principal Investigator
BC Cancer, Vancouver Centre
Shilo Lefresne, MD
Principal Investigator
BC Cancer, Vancouver Centre
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Osimertinib alone or SRS followed by Osimertinib for brain metastases
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Stereotactic Radiotherapy
Osimertinib is already approved in United States, European Union for the following indications:
- 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
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
British Columbia Cancer Agency
Lead Sponsor
Princess Margaret Hospital, Canada
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
AstraZeneca
Industry Sponsor
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