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Monoclonal Antibodies

Amivantamab + Lazertinib + Chemotherapy for Non-Small Cell Lung Cancer (MARIPOSA-2 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

Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation

Must not have

Participant with symptomatic or progressive brain metastases

Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 48 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two different cancer treatments in people with lung cancer that has continued to grow despite treatment with osimertinib.

Who is the study for?

This trial is for adults with advanced non-squamous NSCLC who have an EGFR mutation and whose cancer has worsened after osimertinib treatment. They should be relatively healthy otherwise, with a good performance status (ECOG 0 or 1), and women must test negative for pregnancy. People can't join if they've had certain serious health issues like small cell lung transformation, untreated brain metastases, ILD, significant heart disease, or are at high risk of blood clots without proper anticoagulation.

What is being tested?

The study tests the effectiveness of combining Amivantamab and Lazertinib with platinum-based chemotherapy (Carboplatin/Pemetrexed) against just the chemotherapy in patients whose NSCLC has progressed post-Osimertinib therapy. It aims to see if adding these targeted therapies improves outcomes.

What are the potential side effects?

Potential side effects include reactions related to infusion treatments, increased risk of lung problems like pneumonitis, skin reactions from Amivantamab, liver enzyme changes due to Lazertinib, and typical chemo-related issues such as fatigue, nausea, low blood counts increasing infection risks.

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 restricted in physically strenuous activity but can do light work.

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My lung cancer is advanced, non-squamous, and has specific EGFR mutations.

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I have at least one tumor that can be measured and hasn't been treated with radiation.

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My lung cancer is advanced, non-squamous, and has specific EGFR mutations.

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I have treated brain metastases and take no more than 10mg of prednisone daily for it.

Exclusion Criteria

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

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I have brain metastases that are causing symptoms or getting worse.

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I have a history of serious heart or blood clot issues.

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My cancer has changed into small cell type.

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I have or had cancer spread to the lining of my brain or spinal cord, or untreated spinal cord compression.

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I have a history of lung scarring or inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to'approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to'approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to'approximately 48 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 RECIST v1.1 Guidelines as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Duration of Response (DoR)

European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score

Intracranial Duration of Response (DOR) as Assessed by BICR

+15 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)Experimental Treatment3 Interventions

Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.

Group II: Arm C2 (Extension Cohort): ACPExperimental Treatment3 Interventions

Group III: Arm A: LACP/ACP-LExperimental Treatment4 Interventions

LACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.

Group IV: Arm A2 (Extension Cohort): ACP-LExperimental Treatment4 Interventions

Participants will receive Amivantamab, Pemetrexed and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier). After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.

Group V: Arm B: CP (Carboplatin and Pemetrexed)Active Control2 Interventions

Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550