73 Participants Needed
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Premedication for Amivantamab + Lazertinib in Non-Small Cell Lung Cancer

Recruiting in Fairfax (>99 mi)
+46 other locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

JR

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

I am using an additional barrier method along with oral contraceptives.
I am fully active or can carry out light work.
I will use a condom during and 3 months after the study treatments.
See 4 more

Exclusion Criteria

I have brain metastases but am stable and not on steroids for at least 2 weeks.
I haven't taken anti PD-1 or PD-L1 drugs in the last 6 weeks and any rash from previous treatments has healed.
Side effects from my previous cancer treatments have mostly gone away.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive premedication with dexamethasone, montelukast, or methotrexate prior to amivantamab infusion to reduce infusion-related reactions

3 cycles (each cycle 28 days)
Multiple visits per cycle for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after end of treatment

Treatment Details

Interventions

  • Amivantamab
Trial OverviewThe study tests if premedication with dexamethasone, montelukast, or methotrexate can reduce reactions to the first dose of amivantamab infusion. Amivantamab is given through an IV alongside oral lazertinib to see how well they work together against NSCLC after other treatments have failed.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Background Anti-cancer Therapy with Amivantamab Plus LazertinibExperimental Treatment5 Interventions
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.

Amivantamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Rybrevant for:
  • 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
🇪🇺
Approved in European Union as Rybrevant for:
  • 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?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore profile image

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar profile image

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

The ongoing CHRYSALIS study shows that the combination of amivantamab, an EGFR-MET bispecific antibody, and lazertinib, a third-generation EGFR TKI, is effective in treating both treatment-naive patients and those who have relapsed after osimertinib.
The MARIPOSA study is a phase 3 trial designed to compare the safety and efficacy of the amivantamab and lazertinib combination therapy against single-agent osimertinib, aiming to improve first-line treatment outcomes for patients with EGFR-mutant non-small-cell lung cancer.
MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer.Cho, BC., Felip, E., Hayashi, H., et al.[2022]
In a phase III trial involving 657 patients with advanced EGFR-mutated non-small-cell lung cancer, both amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy significantly improved progression-free survival (PFS) compared to standard chemotherapy, with median PFS of 6.3 and 8.3 months versus 4.2 months, respectively.
The combination therapies also showed a higher objective response rate (64% and 63% for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy, respectively) compared to chemotherapy (36%), although the amivantamab-lazertinib-chemotherapy regimen had more hematologic adverse events.
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study.Passaro, A., Wang, J., Wang, Y., et al.[2023]
Amivantamab, approved for treating non-small cell lung cancer with specific genetic mutations, works by targeting two pathways: the epithelial growth factor receptor and mesenchymal epithelial transition factor, enhancing the immune response against cancer cells.
Preclinical studies indicate that Amivantamab effectively inhibits cancer cell growth in models with exon20 insertions of the epithelial growth factor receptor, suggesting its potential as a targeted therapy for this specific patient population.
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer.Billowria, K., Das Gupta, G., Chawla, PA.[2023]

References

MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. [2022]
Amivantamab plus Lazertinib Is Efficacious in Non-Small Cell Lung Cancer. [2023]
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. [2023]
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer. [2023]
Amivantamab in the Treatment of Metastatic NSCLC: Patient Selection and Special Considerations. [2022]
Amivantamab-Vmjw: A Novel Treatment for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutation after Progression on Platinum-Based Chemotherapy. [2023]
Amivantamab: First Approval. [2021]
Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial. [2023]