Sapanisertib + Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the side effects and optimal dose of combining two drugs, sapanisertib and osimertinib, for advanced non-small cell lung cancer. It focuses on patients whose cancer has a specific mutation (EGFR mutation) and has worsened after similar treatment. The researchers aim to determine if these drugs can effectively stop cancer cell growth. This trial may suit those with stage IV non-small cell lung cancer who have experienced disease progression after taking osimertinib. 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 combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop taking certain medications, including strong inhibitors or inducers of specific liver enzymes (CYP3A4, CYP3A5, CYP2C19, CYP2C9) and proton pump inhibitors, at least three weeks before starting the study. You also cannot take systemic corticosteroids within one week before the first dose of the study drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that osimertinib is usually well-tolerated by patients with specific lung cancer mutations. Earlier studies have shown promising results regarding its safety, with patients reporting manageable side effects.
Past studies have examined sapanisertib both alone and with other drugs to determine the safest and most effective dose. Although detailed safety information on using sapanisertib and osimertinib together is limited, ongoing research is investigating their combined effects. Early trials like this primarily focus on understanding the safety and optimal dosing of treatments, making safety a key concern.
Overall, these treatments are still under study to ensure their safety and effectiveness when used together. Researchers closely monitor trial participants to manage any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of sapanisertib and osimertinib for non-small cell lung cancer because it targets the disease in a unique way. While standard treatments, like other tyrosine kinase inhibitors, typically focus on blocking specific growth signals in cancer cells, sapanisertib adds a new layer by inhibiting mTOR, a protein that helps cancer cells grow and survive. This dual approach could potentially overcome resistance that often develops with existing treatments, offering hope for more effective management of the disease. Additionally, utilizing both drugs together might enhance their overall efficacy, potentially leading to better outcomes for patients.
What evidence suggests that sapanisertib and osimertinib could be effective for non-small cell lung cancer?
Research has shown that osimertinib effectively treats non-small cell lung cancer, particularly when specific changes occur in the EGFR gene. It blocks certain proteins that promote cancer cell growth. Sapanisertib is believed to function similarly by inhibiting tumor cell growth. In this trial, participants will receive a combination of sapanisertib and osimertinib. Studies have found that this combination is safe and might enhance treatment effectiveness. Early trial results suggest this combination could slow cancer progression in patients who have previously used other EGFR-targeting treatments.12567
Who Is on the Research Team?
Penelope A. Bradbury
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with stage IV non-small cell lung cancer that has specific EGFR mutations and worsened after treatment with an EGFR inhibitor. Participants must have good physical function, measurable disease, meet certain lab criteria, not be pregnant or breastfeeding, and able to consent. Those with serious illnesses, certain heart conditions, or taking drugs that interact badly with the trial medications cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients receive sapanisertib and osimertinib to determine the safety and recommended phase II dose
Dose Expansion
Evaluate the safety and preliminary efficacy of the drug combination
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Sapanisertib
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