Osimertinib + Bevacizumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare the effects of combining two treatments, osimertinib and bevacizumab, with using osimertinib alone for non-small cell lung cancer that has spread and involves a specific gene change (EGFR mutation). Osimertinib blocks signals that cause cancer cells to grow, while bevacizumab (also known as Avastin) inhibits the formation of blood vessels that tumors need to grow. The trial seeks to determine if the combination can control cancer and extend patient survival. It suits those with advanced non-small cell lung cancer with an EGFR mutation who haven't received certain prior treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients early access to potentially effective treatments.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you must not be taking medications or supplements that strongly induce CYP3A4. If you are on such medications, you need to stop them before starting the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that osimertinib is generally well-tolerated by patients with non-small cell lung cancer. About 22% of patients experienced serious side effects, which are quite severe. This indicates that while some side effects can occur, most patients do not face major issues.
When combined with bevacizumab, studies have found that this combination can cause more side effects than taking osimertinib alone. Although it may not significantly increase long-term survival, it helps slow the spread of cancer to the brain in patients with certain mutations.
In summary, both treatments are relatively safe, but the combination may lead to more side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of osimertinib and bevacizumab for lung cancer because it offers a unique approach compared to standard treatments like chemotherapy or traditional EGFR inhibitors. Osimertinib is a third-generation EGFR inhibitor that targets specific mutations in cancer cells, potentially offering more precise treatment with fewer side effects. Adding bevacizumab, which inhibits blood vessel growth that tumors need to thrive, could enhance the overall effectiveness by attacking the cancer on two fronts. This combination aims to improve outcomes by increasing the duration of response and progression-free survival for patients.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that osimertinib, which participants in this trial may receive, effectively treats non-small cell lung cancer (NSCLC) with specific EGFR mutations, helping patients live longer. In this trial, some participants will receive osimertinib alone, while others will receive a combination of osimertinib and bevacizumab. Early results suggest that this combination can be particularly beneficial for patients whose cancer has spread to the brain, as it appears to slow cancer growth. However, while some studies show benefits from using both drugs together, others suggest it might not significantly improve long-term survival compared to using osimertinib alone. The side effects of using both drugs are generally manageable.23678
Who Is on the Research Team?
Helena A Yu
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread and have specific EGFR gene mutations. They should not have had previous treatments with EGFR TKI or anti-VEGF agents, no major heart issues, and must not be on strong CYP3A4 inducers. Patients can join if they've finished certain radiation therapies before starting the study drugs and if they don't have severe diseases or conditions that could affect their participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive osimertinib alone or in combination with bevacizumab. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for 10 years.
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Osimertinib
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?
National Cancer Institute (NCI)
Lead Sponsor