Lazertinib + Amivantamab for Non-Small Cell Lung Cancer
(PALOMA-3 Trial)

Recruiting in Palo Alto (17 mi)

+266 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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.

+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.

+3 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Arm B: Lazertinib with Amivantamab Intravenous (IV) InfusionExperimental Treatment2 Interventions

Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.

Group II: Arm A: Lazertinib with Amivantamab SC-CFExperimental Treatment2 Interventions

Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.