43 Participants Needed

Amivantamab + Lazertinib for Lung Cancer

Recruiting at 6 trial locations
AB
Helena Yu, MD profile photo
Overseen ByHelena Yu, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The researchers think that the study drugs, amivantamab and lazertinib, may be an effective treatment for people who have metastatic NSCLC with an EGFR mutation. Both drugs work to target cancer cells with an EGFR mutation, and this targeting action could stop or slow the growth of cancer cells. The researchers are doing this study to find out how well amivantamab and lazertinib work against metastatic NSCLC with an EGFR mutation.

Do I need to stop my current medications for the trial?

The trial requires that you stop taking any EGFR TKI or other oral treatments at least 3 days before starting the study drugs. Additionally, you must not have had systemic chemotherapy within 2 weeks of starting the trial. If you are taking medications or supplements that are potent CYP3A4/5 inducers, you will need to stop them for an appropriate washout period before enrolling.

Is the combination of Amivantamab and Lazertinib safe for humans?

The combination of Amivantamab and Lazertinib has been studied in clinical trials for lung cancer, and the safety profile was generally consistent with previous experiences of each drug alone. In one study, 4% of patients experienced severe side effects, but no new safety concerns were identified.12345

How is the drug combination of Amivantamab and Lazertinib unique for lung cancer treatment?

The combination of Amivantamab and Lazertinib is unique because it targets specific mutations in non-small cell lung cancer (NSCLC) that have become resistant to standard treatments like osimertinib. Amivantamab is a bispecific antibody that targets both EGFR and MET mutations, while Lazertinib is a third-generation EGFR inhibitor, making this combination effective for patients who have relapsed after other therapies.23456

What data supports the effectiveness of the drug combination Amivantamab and Lazertinib for lung cancer?

Research shows that the combination of Amivantamab and Lazertinib is effective in treating non-small cell lung cancer, especially in patients who have relapsed after using another drug called osimertinib. In one study, 36% of patients responded to this combination, and it helped control the disease for about 11 months on average.23456

Who Is on the Research Team?

Helena A. Yu, MD - MSK Thoracic Medical ...

Helena Yu, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread, and have specific EGFR mutations. They must have tried certain treatments like osimertinib without success. Participants need to be able to take oral meds, not be pregnant or breastfeeding, use effective birth control, and have good organ function. People with HIV, recent surgeries or radiotherapy, unresolved lung conditions like ILD, uncontrolled illnesses or other cancers aren't eligible.

Inclusion Criteria

My organs are functioning well.
I have new or worsening brain metastases.
I have cancer cells in my spinal fluid.
See 16 more

Exclusion Criteria

I do not have any active or chronic liver diseases.
You have a positive hepatitis B surface antigen (HBsAg) test.
You have a positive test for hepatitis C.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amivantamab and lazertinib for metastatic NSCLC with EGFR mutation

2 years
Multiple visits for IV administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Amivantamab
  • Lazertinib
Trial Overview The study tests amivantamab and lazertinib in treating metastatic NSCLC with an EGFR mutation. These drugs target cancer cells directly to slow down their growth. The goal is to see how well these drugs work together against this type of lung cancer after standard treatments fail.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Patients with parenchymal brain metastasesExperimental Treatment2 Interventions
Group II: Patients with leptomeningeal (LM) disease with or without parenchymal brain metastasesExperimental Treatment2 Interventions

Amivantamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Rybrevant for:
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Approved in European Union as Rybrevant for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials
165
Recruited
579,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

The ongoing CHRYSALIS study shows that the combination of amivantamab, an EGFR-MET bispecific antibody, and lazertinib, a third-generation EGFR TKI, is effective in treating both treatment-naive patients and those who have relapsed after osimertinib.
The MARIPOSA study is a phase 3 trial designed to compare the safety and efficacy of the amivantamab and lazertinib combination therapy against single-agent osimertinib, aiming to improve first-line treatment outcomes for patients with EGFR-mutant non-small-cell lung cancer.
MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer.Cho, BC., Felip, E., Hayashi, H., et al.[2022]
In a phase III trial involving 657 patients with advanced EGFR-mutated non-small-cell lung cancer, both amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy significantly improved progression-free survival (PFS) compared to standard chemotherapy, with median PFS of 6.3 and 8.3 months versus 4.2 months, respectively.
The combination therapies also showed a higher objective response rate (64% and 63% for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy, respectively) compared to chemotherapy (36%), although the amivantamab-lazertinib-chemotherapy regimen had more hematologic adverse events.
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study.Passaro, A., Wang, J., Wang, Y., et al.[2023]
Amivantamab, a bispecific antibody targeting EGFR and MET, received accelerated FDA approval for treating non-small cell lung cancer (NSCLC) patients with specific EGFR mutations, showing a 40% objective response rate in a Phase I/IB trial with a median response duration of 11.1 months.
In patients with other EGFR mutations, amivantamab alone had a 19% response rate, while combining it with lazertinib improved the response to 36%, indicating potential benefits of combination therapy in NSCLC treatment.
Amivantamab in the Treatment of Metastatic NSCLC: Patient Selection and Special Considerations.Petrini, I., Giaccone, G.[2022]

Citations

Amivantamab plus Lazertinib Is Efficacious in Non-Small Cell Lung Cancer. [2023]
MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. [2022]
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. [2023]
Amivantamab in the Treatment of Metastatic NSCLC: Patient Selection and Special Considerations. [2022]
Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial. [2023]
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer. [2023]
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