418 Participants Needed

Lazertinib + Amivantamab for Non-Small Cell Lung Cancer

(PALOMA-3 Trial)

Recruiting at 266 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Must be taking: EGFR inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have progressed on certain treatments like osimertinib and platinum-based chemotherapy, which might imply changes to your current treatment plan.

How is the drug combination of Lazertinib and Amivantamab unique for treating non-small cell lung cancer?

The combination of Lazertinib and Amivantamab 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, and together they show promise in overcoming resistance and improving outcomes in patients who have relapsed after other therapies.12345

What data supports the effectiveness of the drug Lazertinib + Amivantamab for Non-Small Cell Lung Cancer?

Research shows that breaking down hyaluronan (a substance in the tumor environment) with enzymes like those in Amivantamab can help immune cells and drugs reach tumors more effectively, potentially improving treatment outcomes.678910

Who Is on the Research Team?

JR

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 advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after treatment with osimertinib or similar drugs and chemotherapy. They should be relatively healthy, able to perform daily activities (ECOG 0-1), have at least one measurable tumor, and recovered from previous cancer therapy side effects.

Inclusion Criteria

My lung cancer is advanced or has spread, and tests show specific EGFR mutations.
My cancer progressed after treatment with osimertinib or similar drug and chemotherapy.
I am fully active or restricted in physically strenuous activity but can do light work.
See 2 more

Exclusion Criteria

I have a history of lung scarring or inflammation.
I had radiotherapy for symptom relief less than a week ago.
I have untreated spinal or brain membrane cancer.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lazertinib with either subcutaneous or intravenous Amivantamab, depending on the arm they are assigned to

Up to 1 year 11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension (LTE)

Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment

Up to 4 years 11 months

What Are the Treatments Tested in This Trial?

Interventions

  • Amivantamab Intravenous
  • Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
  • Lazertinib
Trial Overview The study tests a new way to give the drug amivantamab by injecting it under the skin instead of into a vein. This could make treatment quicker and easier. Participants will receive either this new subcutaneous version combined with lazertinib or the standard intravenous amivantamab also with lazertinib.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm B: Lazertinib with Amivantamab Intravenous (IV) InfusionExperimental Treatment2 Interventions
Group II: Arm A: Lazertinib with Amivantamab SC-CFExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Published Research Related to This Trial

The new HA-paclitaxel bioconjugate, ONCOFID-P, showed improved effectiveness in treating ovarian cancer in mice compared to traditional intravenous and intraperitoneal free paclitaxel, particularly in reducing tumor spread and prolonging survival.
While ONCOFID-P was slightly less effective in vitro against ovarian cancer cell lines than free paclitaxel, it demonstrated similar levels of myelotoxicity, suggesting it can be safely administered at higher doses for better locoregional treatment outcomes.
Hyaluronic acid-paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts.De Stefano, I., Battaglia, A., Zannoni, GF., et al.[2017]
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

Human Hyaluronidase PH20 Potentiates the Antitumor Activities of Mesothelin-Specific CAR-T Cells Against Gastric Cancer. [2021]
Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma. [2022]
Remodeling the Tumor Microenvironment Sensitizes Breast Tumors to Anti-Programmed Death-Ligand 1 Immunotherapy. [2020]
Hyaluronic acid-paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts. [2017]
Tumor-associated hyaluronan limits efficacy of monoclonal antibody therapy. [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 Is Efficacious in Non-Small Cell Lung Cancer. [2023]
Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial. [2023]
MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. [2022]
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