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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights
MARIPOSA 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.Check my eligibility
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.See study design
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.
MARIPOSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
MARIPOSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS) According to RECIST v1.1 by Blinded Independent Central Review (BICR)
Secondary outcome measures
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 moreMARIPOSA 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
Placebo
1995
Completed Phase 3
~2670
Lazertinib
2021
Completed Phase 2
~770
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,234 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,958,831 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one tumor that can be measured and hasn't been treated with radiation.I haven't had systemic treatment for advanced or metastatic cancer but may have had treatment for early-stage cancer over a year ago.I have or had leptomeningeal disease.I have brain metastases that are either causing symptoms, have no symptoms, or are stable after treatment.I can provide tissue and blood samples for genetic testing.I have a stable spinal condition after treatment, and I'm on low-dose or no steroids.I have newly diagnosed advanced lung cancer that can't be cured with surgery or chemoradiation.I am not allergic to amivantamab, lazertinib, or osimertinib.My tumor has specific genetic changes known as Exon 19 deletion or Exon 21 L858R substitution.I have or had lung inflammation not caused by an infection.Any side effects from my previous cancer treatments have mostly gone away.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib
- Group 2: Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib
- Group 3: Treatment Arm A (Open-label): Amivantamab and Lazertinib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are Amivantamab's most common applications in treatment?
"Amivantamab is a treatment for patients with exons, locally advanced non-small cell lung cancer, and previous platinum based therapy."
Answered by AI
What is the precedent for Amivantamab's efficacy?
"Amivantamab was first studied in 2013 and, to date, 18313 completed studies exist. There are 118 active clinical trials related to Amivantamab with a large concentration based in East Brunswick, New jersey."
Answered by AI
What is the maximum dosage of Amivantamab that has been proven safe for human patients?
"Amivantamab's safety is supported by pre-existing clinical data,so it received a score of 3."
Answered by AI
To your knowledge, has there been research like this done before?
"Amivantamab is being studied in 118 active clinical trials across the globe. The first trial began in 2013 and, after successfully completing Phase 1 & 2, it received drug approval. To date, 18313 studies have been completed on Amivantamab with 603 patients initially involved."
Answered by AI
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