NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lazertinib	Lazertinib tablets will be administered orally.
DRUG	Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)	Amivantamab injection will be administered subcutaneously by manual injection.
DRUG	Amivantamab Intravenous	Amivantamab will be administered by IV infusion.

Timeline

• Start date: 2022-08-05
• Primary completion: 2024-01-03
• Completion: 2027-06-30
• First posted: 2022-05-24
• Last updated: 2026-04-13
• Results posted: 2026-02-02

Locations

187 sites across 20 countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Malaysia, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study