Premedication for Amivantamab + Lazertinib in Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Amivantamab + Lazertinib in treating non-small cell lung cancer?
Research shows that Amivantamab combined with Lazertinib is effective in treating non-small cell lung cancer, especially in patients who have relapsed after using osimertinib. In studies, this combination showed significant tumor reduction and improved progression-free survival in patients with specific genetic mutations.12345
Is Amivantamab safe for humans?
Amivantamab, also known as Rybrevant, has been approved by the FDA for treating certain types of non-small cell lung cancer, indicating it has undergone safety evaluations. Studies have reviewed its safety and clinical applicability, suggesting it is generally safe for use in humans with this condition.23467
How is the drug Amivantamab + Lazertinib unique for treating non-small cell lung cancer?
Amivantamab combined with Lazertinib is unique because it targets specific mutations in non-small cell lung cancer that have become resistant to other treatments, like osimertinib. Amivantamab is a bispecific antibody that targets both EGFR and MET mutations, while Lazertinib is a third-generation EGFR inhibitor, making this combination effective for patients who have relapsed after standard treatments.12348
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR mutations, and who have already been treated with osimertinib and chemotherapy. Participants should be in good physical condition (ECOG grade 0 or 1), not have symptomatic brain metastases, unresolved severe side effects from previous treatments, a history of certain lung diseases, or recent treatment with similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive premedication with dexamethasone, montelukast, or methotrexate prior to amivantamab infusion to reduce infusion-related reactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Amivantamab
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
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires