Amivantamab + Lazertinib for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of two drugs, amivantamab (Rybrevant) and lazertinib, in treating advanced lung cancer. These drugs target a specific mutation in cancer cells, potentially stopping or slowing tumor growth. The trial seeks participants with metastatic non-small cell lung cancer (NSCLC) who have a certain genetic mutation (EGFR) and whose cancer has progressed despite other treatments. Participants should have experienced a worsening of this type of lung cancer even after other therapies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial requires that you stop taking any EGFR TKI or other oral treatments at least 3 days before starting the study drugs. Additionally, you must not have had systemic chemotherapy within 2 weeks of starting the trial. If you are taking medications or supplements that are potent CYP3A4/5 inducers, you will need to stop them for an appropriate washout period before enrolling.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining amivantamab and lazertinib may help treat certain types of lung cancer. Earlier studies tested these drugs together, yielding promising results regarding human safety. Most patients tolerated this combination well.
Another study tested this drug combination on patients with cancer that had spread to the brain and the protective layers around the brain and spinal cord. The results showed that the treatment was effective, and patients managed the side effects. While some side effects occurred, no unexpected or severe reactions emerged, suggesting the treatment is relatively safe for humans.
These findings are part of ongoing research, demonstrating that the drugs work together to target cancer cells with specific mutations. The studies provide strong evidence for safety, making this treatment an option worth considering for those eligible to participate in clinical trials.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Amivantamab and Lazertinib for lung cancer because they target specific genetic mutations in cancer cells, offering a more personalized treatment approach. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, Amivantamab is an antibody that targets the EGFR and MET pathways, which are often altered in lung cancer. Lazertinib is a third-generation EGFR inhibitor that is designed to overcome resistance seen with earlier treatments. Together, these drugs have the potential to be more effective and cause fewer side effects by precisely targeting cancer cells.
What evidence suggests that amivantamab and lazertinib might be an effective treatment for metastatic NSCLC with an EGFR mutation?
Research has shown that combining amivantamab and lazertinib may help treat non-small cell lung cancer (NSCLC) with an EGFR mutation. Studies have found that this combination effectively targets and slows cancer growth, particularly against resistance mutations common with other treatments. Early results suggest it is effective for patients whose cancer has spread to the brain and the membranes around the brain and spinal cord. In this trial, all participants will receive both amivantamab and lazertinib, offering new hope for those facing this challenging condition.12467
Who Is on the Research Team?
Helena Yu, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
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 mutations. They must have tried certain treatments like osimertinib without success. Participants need to be able to take oral meds, not be pregnant or breastfeeding, use effective birth control, and have good organ function. People with HIV, recent surgeries or radiotherapy, unresolved lung conditions like ILD, uncontrolled illnesses or other cancers aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab and lazertinib for metastatic NSCLC with EGFR mutation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Lazertinib
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University