Erlotinib + Cabozantinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how well the drugs erlotinib and cabozantinib (also known as Cabometyx or Cometriq) work alone or together in treating stage IV non-small cell lung cancer. Both drugs block certain enzymes to stop cancer cell growth. Eligible participants include those with stage IV non-small cell lung cancer and measurable disease who have already undergone one or two chemotherapy treatments. The trial will test the drugs separately and in combination to determine the most effective approach. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. Specifically, you must not be on strong CYP3A4 inducers or therapeutic doses of certain anticoagulants. If you are taking any of these, you may need to stop or adjust them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that erlotinib hydrochloride is usually well-tolerated by people with non-small cell lung cancer. Common side effects include mild to moderate skin rash and diarrhea, which past studies indicate can usually be managed.
For cabozantinib-s-malate, most safety information comes from patients with advanced kidney cancer. These patients experienced side effects like tiredness and changes in liver function, but adjustments to their medication usually managed these issues.
Limited safety information exists for using both drugs together. However, since both drugs have been studied separately, they might have similar side effects when combined. This trial phase suggests the treatments are considered safe enough for further testing in people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Erlotinib and Cabozantinib for treating non-small cell lung cancer because these drugs target cancer in unique ways. Erlotinib is a tyrosine kinase inhibitor that blocks signals the cancer cells need to grow, while Cabozantinib inhibits multiple pathways, including VEGFR and MET, which are involved in tumor angiogenesis and growth. This dual-action approach could potentially overcome resistance seen with standard treatments that typically focus on a single target. By combining these mechanisms, this treatment may offer a more comprehensive attack on cancer cells, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Studies have shown that erlotinib can help patients with non-small cell lung cancer live longer and feel better by blocking certain proteins on cancer cells, which helps stop their growth. Cabozantinib has also shown promise in treating advanced non-small cell lung cancer by slowing the disease. In this trial, some participants will receive erlotinib alone, while others will receive cabozantinib alone. Another treatment arm will provide both erlotinib and cabozantinib together, which might be more effective because both target enzymes that cancer cells need to grow. Early research suggests this combination can provide significant benefits. The available evidence supports a hopeful outlook for these treatments in fighting this type of lung cancer.678910
Who Is on the Research Team?
Joel W Neal
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with Stage IV non-small cell lung cancer who have a specific mutation in the EGFR gene, have received 1-2 prior chemotherapy treatments, and can swallow tablets. They should not have had certain previous cancer therapies or major health issues 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 erlotinib, cabozantinib, or both, orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 2 years, then every 6 months for up to 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Cabozantinib S-malate
- Erlotinib Hydrochloride
Cabozantinib S-malate is already approved in United States, European Union for the following indications:
- Advanced renal cell carcinoma (RCC)
- Hepatocellular carcinoma (HCC)
- Locally advanced or metastatic differentiated thyroid cancer (DTC)
- Medullary thyroid cancer
- Advanced renal cell carcinoma (RCC)
- Hepatocellular carcinoma (HCC)
- Locally advanced or metastatic differentiated thyroid cancer (DTC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor