Amivantamab + Lazertinib + Chemotherapy for Non-Small Cell Lung Cancer
(MARIPOSA-2 Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking osimertinib at least 8 days before starting the study treatment. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the trial team.
What data supports the effectiveness of the drug combination Amivantamab, Lazertinib, and Chemotherapy for Non-Small Cell Lung Cancer?
Research shows that Amivantamab combined with chemotherapy (Carboplatin and Pemetrexed) and sometimes Lazertinib has shown antitumor activity in patients with advanced non-small-cell lung cancer, especially those with specific genetic mutations. This combination has been effective in patients who have not responded to other treatments, like osimertinib.12345
Is the combination of Amivantamab, Lazertinib, and Chemotherapy safe for humans?
What makes the drug combination of Amivantamab, Lazertinib, and Chemotherapy unique for treating non-small cell lung cancer?
This drug combination is unique because it targets specific mutations in non-small cell lung cancer (NSCLC) that have become resistant to other treatments, like osimertinib. Amivantamab is a bispecific antibody that targets both EGFR and MET mutations, while Lazertinib is a third-generation EGFR inhibitor that can penetrate the brain, making this combination effective even after other treatments have failed.12358
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lazertinib, Amivantamab, Pemetrexed, and Carboplatin for 4 cycles, followed by maintenance therapy until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Amivantamab
- Carboplatin
- Lazertinib
- Pemetrexed
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires