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Monoclonal Antibodies

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

Q: Has the combination of amivantamab and lazertinib been endorsed by the Food & Drug Administration?

<p>The safety of Background Anti-<a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> Therapy with Amivantamab Plus Lazertinib is estimated to be a 2, as this is part of Phase 2 clinical trials and there are some data points that confirm its security but none which prove its efficacy.</p>

Phase 2

Recruiting

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])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Infusion-related Reactions (IRRs)

Secondary outcome measures

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

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

Dexamethasone

2007

Completed Phase 4

~2590

Montelukast

2008

Completed Phase 4

~15460

Methotrexate

2013

Completed Phase 4

~3800

Lazertinib

2021

Completed Phase 2

~770

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,241 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,838 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05663866 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT05663866 — Phase 2

Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05663866 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of amivantamab and lazertinib been endorsed by the Food & Drug Administration?

"The safety of Background Anti-cancer Therapy with Amivantamab Plus Lazertinib is estimated to be a 2, as this is part of Phase 2 clinical trials and there are some data points that confirm its security but none which prove its efficacy."

Answered by AI

Are there any vacancies yet for participants in this research study?

"Clinicaltrials.gov shows that this trial, which was posted on April 9th 2023 and last updated January 31st of the same year, is not currently recruiting patients. Nevertheless, at present there are 1,319 other clinical trials actively searching for volunteers to take part in their research projects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

2023. "Premedication to Reduce Amivantamab Associated Infusion Related Reactions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05663866.

All > Non Small Cell Lung Cancer