Lazertinib + Amivantamab for Non-Small Cell Lung Cancer
(PALOMA-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have progressed on certain treatments like osimertinib and platinum-based chemotherapy, which might imply changes to your current treatment plan.
How is the drug combination of Lazertinib and Amivantamab unique for treating non-small cell lung cancer?
The combination of Lazertinib and Amivantamab is unique because it targets specific mutations in non-small cell lung cancer (NSCLC) that have become resistant to standard treatments like osimertinib. Amivantamab is a bispecific antibody that targets both EGFR and MET mutations, while Lazertinib is a third-generation EGFR inhibitor, and together they show promise in overcoming resistance and improving outcomes in patients who have relapsed after other therapies.12345
What data supports the effectiveness of the drug Lazertinib + Amivantamab for Non-Small Cell Lung Cancer?
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after treatment with osimertinib or similar drugs and chemotherapy. They should be relatively healthy, able to perform daily activities (ECOG 0-1), have at least one measurable tumor, and recovered from previous cancer therapy side effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lazertinib with either subcutaneous or intravenous Amivantamab, depending on the arm they are assigned to
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Extension (LTE)
Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab Intravenous
- Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
- Lazertinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University