Amivantamab + Lazertinib vs Osimertinib for Non-Small Cell Lung Cancer
(MARIPOSA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new combination of drugs, amivantamab (an antibody therapy) and lazertinib (a targeted therapy), outperforms the existing treatment, osimertinib (a targeted therapy), for individuals with a specific type of non-small cell lung cancer (NSCLC) that has certain genetic mutations (EGFR mutations). The trial includes three groups: one group receives amivantamab and lazertinib, another receives osimertinib with a placebo, and the last receives lazertinib with a placebo. Individuals with newly diagnosed, advanced NSCLC who have not received prior treatment and whose cancer has specific genetic changes might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that any toxicities from prior anticancer therapy must have resolved, which might imply a need to stop certain treatments. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of amivantamab and lazertinib is generally well-tolerated by patients. Studies indicate that this combination is more effective than lazertinib alone for treating EGFR-mutant NSCLC, a type of lung cancer. Most side effects can be managed, and the treatment is considered safe for many individuals.
For lazertinib alone, research suggests it is effective and safe for treating non-small cell lung cancer with specific EGFR mutations, with patients often experiencing mild to moderate side effects.
The FDA has already approved osimertinib for certain lung cancers, indicating its safety. It is known to be well-tolerated, with side effects that are usually mild and manageable.
This trial compares these treatments, and existing evidence suggests they are generally safe options.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments being tested for non-small cell lung cancer because they offer promising new approaches compared to existing options like Osimertinib. Amivantamab is unique because it is an antibody that targets both EGFR and MET receptors, potentially overcoming resistance to other therapies. Lazertinib, on the other hand, is a third-generation EGFR inhibitor that might provide a more effective option for patients who have developed resistance to first- and second-generation EGFR inhibitors. Combining these advanced mechanisms, researchers hope to improve patient outcomes by tackling cancer cells more effectively and potentially reducing treatment resistance.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that a combination of two drugs, amivantamab and lazertinib, may be promising for treating non-small cell lung cancer (NSCLC) with certain EGFR mutations. In this trial, some participants will receive this combination, which studies have found can lead to better results than using lazertinib alone. Early data suggests that patients on the combination treatment are living longer, as they have not yet reached the average survival time. Another group in this trial will receive lazertinib alone, which has also been effective, particularly in treating cancer that has spread to the brain in patients with EGFR-mutant NSCLC. For comparison, a separate group will receive osimertinib, a well-known treatment for EGFR-mutant NSCLC, recognized for its effectiveness in similar cases.12367
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either amivantamab and lazertinib combination, osimertinib, or lazertinib as first-line treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Lazertinib
- Osimertinib
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University