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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
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 belowSelect...
I am fully active or can carry out light work.
Select...
My lung cancer has a specific EGFR mutation.
Select...
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:Select...
I have previously been treated with amivantamab or lazertinib.
Select...
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
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 moreTrial 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
Lazertinib
2021
Completed Phase 2
~770
Dexamethasone
2007
Completed Phase 4
~2640
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,585 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,385 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using an additional barrier method along with oral contraceptives.I am fully active or can carry out light work.I have brain metastases but am stable and not on steroids for at least 2 weeks.I will use a condom during and 3 months after the study treatments.I haven't taken anti PD-1 or PD-L1 drugs in the last 6 weeks and any rash from previous treatments has healed.My lung cancer has a specific EGFR mutation.Side effects from my previous cancer treatments have mostly gone away.I have previously been treated with amivantamab or lazertinib.I've had osimertinib and platinum-based chemo but my cancer still progressed.I have a history of lung scarring or inflammation.My condition is advanced or metastatic non-small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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