Osimertinib + SABR for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two treatments, osimertinib (a targeted therapy drug) and Stereotactic Ablative Radiation (SABR), for a specific type of lung cancer. It targets individuals with advanced non-small cell lung cancer (NSCLC) that has certain genetic changes (EGFR mutations) and cannot be treated with surgery or regular radiation. The trial is suitable for those with these mutations and a tumor measurable by scans like CT or MRI. The research aims to determine if this combination can improve outcomes for people with this type of lung cancer. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to potentially benefit from innovative therapy.
Do I need to stop my current medications for the trial?
You may need to stop taking certain medications or herbal supplements that are known to strongly affect CYP3A4, an enzyme in the body, at least three weeks before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that the combination of osimertinib and Stereotactic Ablative Radiation (SABR) was well-tolerated, with most participants not experiencing serious side effects. The research indicated that adding SABR to osimertinib helped extend the lives of cancer patients compared to using osimertinib alone. This finding is promising because both treatments have been used safely on their own in other studies. Although limited information exists on side effects when combined, the treatments have a history of safety when used separately.12345
Why are researchers excited about this trial's treatments?
Osimertinib is unique because it combines with Stereotactic Ablative Radiation (SABR) to treat lung cancer, offering a potentially more effective approach than traditional chemotherapy or radiation alone. Unlike standard treatments that often target cancer cells broadly, Osimertinib specifically targets and inhibits the EGFR (epidermal growth factor receptor) mutation, which is a common driver of lung cancer growth. This targeted action means it can potentially reduce side effects and improve outcomes for patients with this specific mutation. Researchers are excited because this combination may enhance the precision and efficacy of treatment, offering hope for better survival rates and quality of life for patients.
What evidence suggests that the combination of osimertinib and SABR could be effective for lung cancer?
Research has shown that osimertinib effectively treats certain lung cancers. Studies have found that patients with EGFR-mutated non-small cell lung cancer experienced positive results with osimertinib. Specifically, one study revealed that 84% of these patients were still alive three years after starting the treatment. In this trial, participants will receive osimertinib combined with Stereotactic Ablative Radiation (SABR), a precise type of radiation therapy, to potentially enhance its effectiveness. Overall, osimertinib is considered effective and well-tolerated for treating certain lung cancers, especially when combined with other therapies like SABR.678910
Who Is on the Research Team?
Sawsan Rashdan, MD
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced EGFR mutant NSCLC, who can't have surgery or radiotherapy. They should expect to live at least 12 weeks and have good organ function. Participants must not be pregnant, breastfeeding, or planning to get pregnant and agree to use contraception. People with certain heart conditions, uncontrolled diseases, a history of severe lung issues like ILD, or those who've had specific treatments like osimertinib are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants receive osimertinib for 8 weeks to target EGFR mutant lung cancer
Radiation
Persisting lesions are treated with stereotactic ablative radiation (SABR) after 8 weeks of osimertinib therapy
Continued Treatment
Participants continue osimertinib therapy post-radiation; repeat SABR may be performed if progression occurs
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Stereotactic Ablative Radiation (SABR)
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?
University of Texas Southwestern Medical Center
Lead Sponsor
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