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Monoclonal Antibodies

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

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent])

Must not have

Prior treatment with amivantamab or lazertinib

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates if pre-treatment drugs reduce side effects when taking amivantamab and Lazertinib to treat cancer.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include allergic reactions during infusion which could cause symptoms like fever and chills. Dexamethasone may cause mood swings or increased blood sugar; montelukast might lead to abdominal pain; methotrexate can result in mouth sores and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My lung cancer has a specific EGFR mutation.

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My condition is advanced or metastatic non-small cell lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with amivantamab or lazertinib.

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I have a history of lung scarring or inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Infusion-related Reactions (IRRs)

Secondary study objectives

Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1

Duration of Response (DOR)

Overall Response Rate (ORR)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Montelukast

2008

Completed Phase 4

~15460

Methotrexate

2019

Completed Phase 4

~4400