Gilteritinib for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test the safety of gilteritinib, a medication, in individuals with ALK-positive non-small cell lung cancer (NSCLC). This cancer arises from a faulty ALK gene, and the trial targets those whose cancer has worsened despite using ALK inhibitors. Participants will take gilteritinib pills daily in 28-day cycles to assess tolerance. Eligible participants have advanced or metastatic ALK-positive NSCLC and have stopped responding to ALK inhibitors like alectinib or lorlatinib. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot take certain drugs that affect specific receptors or enzymes. 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 gilteritinib is likely to be safe for humans?
Research has shown that gilteritinib is generally safe for people with certain cancers, such as acute myeloid leukemia (AML). The FDA has approved it for AML, confirming its safety in humans. When used for AML, gilteritinib has provided significant benefits, including longer survival compared to chemotherapy.
For lung cancer with the ALK gene (ALK-positive NSCLC), studies have found that gilteritinib can effectively target cancer cells. This could offer a new treatment option for those who no longer respond to current ALK inhibitors. However, specific safety information for gilteritinib in lung cancer patients is still being collected. This trial is in its early stages and focuses on safety, aiming to ensure gilteritinib is well-tolerated by participants. Early trials like this involve careful monitoring to understand any side effects, helping to create a more complete safety profile.12345Why do researchers think this study treatment might be promising for lung cancer?
Gilteritinib is unique because it offers a new approach to treating lung cancer by specifically targeting and inhibiting FLT3, a protein that can drive cancer growth. Current standard treatments for lung cancer typically include chemotherapy, targeted therapies, or immunotherapy, which work differently by attacking cancer cells more broadly or enhancing the immune system's response. Researchers are excited about gilteritinib because its targeted mechanism may potentially lead to more effective treatment outcomes with potentially fewer side effects, compared to the broader impact of conventional therapies. Additionally, the ability to adjust the dose for those who tolerate the drug well and achieve stable disease suggests a tailored treatment approach that could improve patient outcomes.
What evidence suggests that gilteritinib might be an effective treatment for ALK-positive NSCLC?
Research has shown that gilteritinib yields promising results for treating certain cancers. In studies comparing it to alectinib, gilteritinib proved more effective against ALK-rearranged non-small cell lung cancer (NSCLC). It has also controlled other diseases, such as acute myeloid leukemia (AML), over the long term. While these results are encouraging for ALK-positive NSCLC, further research is needed to confirm its efficacy for this specific cancer type. Participants in this trial will receive gilteritinib once daily in a 28-day cycle to further evaluate its effectiveness for lung cancer.23456
Who Is on the Research Team?
Medical Monitor
Principal Investigator
Astellas Pharma Global Development, Inc.
Are You a Good Fit for This Trial?
Adults with advanced ALK-positive NSCLC who have stopped responding to previous ALK inhibitors like alectinib or lorlatinib. They must not have symptomatic brain cancers, recent major surgeries, certain heart conditions, or recent serious infections. Women of childbearing potential must test negative for pregnancy and agree to contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gilteritinib once daily in a 28-day cycle, with potential dose adjustments based on tolerance and safety checks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with regular health check-ins every 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Gilteritinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available