← Back to Search

Monoclonal Antibodies

Amivantamab + Lazertinib vs Osimertinib for Non-Small Cell Lung Cancer (MARIPOSA Trial)

Phase 3

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

Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for ctDNA, ddPCR, and pharmacogenomic analysis)

Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation

Must not have

Participant has an active or past medical history of leptomeningeal disease

Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to either disease progression or death whichever occurs first (up to 32.8 months)

Awards & highlights

Pivotal Trial

Summary

This trial will compare amivantamab and lazertinib with osimertinib to see if the first two are more effective in treating NSCLC.

Who is the study for?

This trial is for adults with a specific type of advanced lung cancer (NSCLC) that hasn't been treated before and can't be cured with surgery or radiation. Their tumors must have certain genetic changes (Exon 19 deletions or Exon 21 L858R substitution). They need at least one measurable tumor lesion, no active brain metastases, and no history of severe lung disease.

What is being tested?

The study compares the effectiveness of two treatments: a combination therapy using Amivantamab and Lazertinib versus Osimertinib alone in patients with advanced NSCLC carrying specific genetic mutations. The goal is to see which treatment works better for this condition.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs' ingredients, issues related to infusion such as discomfort or pain at the injection site, potential worsening of lung conditions like pneumonitis, and general side effects from cancer therapies like fatigue, nausea, and skin reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can provide tissue and blood samples for genetic testing.

Select...

I have newly diagnosed advanced lung cancer that can't be cured with surgery or chemoradiation.

Select...

My tumor has specific genetic changes known as Exon 19 deletion or Exon 21 L858R substitution.

Select...

Any side effects from my previous cancer treatments have mostly gone away.

Exclusion Criteria

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

Select...

I have or had leptomeningeal disease.

Select...

I am not allergic to amivantamab, lazertinib, or osimertinib.

Select...

I have or had lung inflammation not caused by an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to either disease progression or death whichever occurs first (up to 32.8 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to either disease progression or death whichever occurs first (up to 32.8 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to either disease progression or death whichever occurs first (up to 32.8 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

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

Change from Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)

Duration of Response (DOR)

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm C (Double-blind): Lazertinib+Placebo OsimertinibExperimental Treatment2 Interventions

Participants will receive lazertinib 240 mg (80\*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.

Group II: Treatment Arm A (Open-label): Amivantamab and LazertinibExperimental Treatment2 Interventions

Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (\<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (\>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80\*3) orally once daily.

Group III: Treatment Arm B (Double-blind): Osimertinib+Placebo LazertinibActive Control2 Interventions

Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80\*3) orally once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

2021

Completed Phase 2

~770

Placebo

1995