Minnelide + Osimertinib for Lung Cancer
Trial Summary
What is the purpose of this trial?
This trial tests Minnelide and Osimertinib together to treat advanced lung cancer with a specific gene mutation. Minnelide becomes an active drug in the body, and Osimertinib blocks a protein needed for cancer growth. This combination aims to help patients whose cancer grows faster due to this specific gene mutation. Osimertinib is a third-generation medication approved for treating a type of lung cancer with specific gene mutations.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting, including strong CYP3A4 inducers/inhibitors, some antiarrhythmic agents, herbal and alternative medications, and specific drugs like clarithromycin, loperamide, and ondansetron. If you're taking any of these, you may need to stop them before joining the trial.
What data supports the effectiveness of the drug combination Minnelide and Osimertinib for lung cancer?
Osimertinib has shown effectiveness in treating non-small-cell lung cancer (NSCLC) with specific mutations, particularly the EGFR T790M mutation, which is a common resistance mechanism to earlier treatments. It has demonstrated efficacy in clinical trials and real-world settings for patients with EGFR-mutant NSCLC.12345
Is the combination of Minnelide and Osimertinib safe for humans?
Osimertinib has been studied for lung cancer and common side effects include diarrhea, rash, dry skin, and nail issues. Serious side effects occurred in about 28% of patients, with some stopping treatment due to these effects. There is no specific safety data available for Minnelide in combination with Osimertinib.25678
What makes the drug combination of Minnelide and Osimertinib unique for lung cancer treatment?
The combination of Minnelide and Osimertinib is unique because it pairs a novel compound, Minnelide, with Osimertinib, a third-generation drug specifically targeting a mutation in lung cancer cells that often leads to resistance against other treatments. This combination aims to enhance effectiveness by addressing resistance mechanisms in non-small cell lung cancer.234910
Research Team
Erminia Massarelli, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
Adults with advanced non-small cell lung cancer that has spread and have specific EGFR gene mutations. They must have had tumor progression after standard osimertinib treatment, be able to swallow pills, not be pregnant or breastfeeding, use effective birth control, and agree to research biopsies. Excluded are those with certain heart conditions, active infections requiring systemic therapy, recent use of strong CYP3A4 inducers/inhibitors or antiarrhythmic agents.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive minnelide orally once daily on days 1-21 and osimertinib once daily on days 1-28. Cycles repeat every 28 days for 6 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months for 2 years.
Treatment Details
Interventions
- Minnelide
- Osimertinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator