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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

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.Check my eligibility
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.See study design
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 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

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 Guidelines as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
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

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
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 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
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Lazertinib
2021
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,383,517 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,171 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04988295 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A: LACP/ACP-L, Arm B: CP (Carboplatin and Pemetrexed), Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed), Arm A2 (Extension Cohort): ACP-L, Arm C2 (Extension Cohort): ACP
Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT04988295 — Phase 3
Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04988295 — Phase 3
~212 spots leftby Jul 2025
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