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

Phase 3 Active, not recruiting NCT05388669

Condition	Advanced or Metastatic Non-small Cell Lung Cancer
Phase	Phase 3
Sponsor	Janssen Research & Development, LLC
Status	Active, not recruiting
Enrollment	418 participants
Interventions	Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous
Start date	Aug 5, 2022
Completion date	Jan 3, 2024
Results posted	Feb 2, 2026

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.

For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State

Pre-dose on Cycle 4 Day 1 (each cycle of 28 days) · micrograms per milliliters (mcg/mL)

Arm A: Lazertinib With Amivantamab SC-CF	206 ± 39.1 micrograms per milliliters (mcg/mL)
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion	144 ± 41.5 micrograms per milliliters (mcg/mL)

Cox regression model	1.427 (95% CI 1.266–1.610)

For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab

Pre-dose on Cycle 2 Day 1 (each cycle of 28 days) · mcg/mL

Arm A: Lazertinib With Amivantamab SC-CF	335 ± 32.7 mcg/mL
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion	293 ± 31.7 mcg/mL

Cox regression model	1.145 (95% CI 1.040–1.261)

Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2

Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1 · micrograms*hour per milliliters

Arm A: Lazertinib With Amivantamab SC-CF	135861 ± 30.7 micrograms*hour per milliliters
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion	131704 ± 24.0 micrograms*hour per milliliters

Geometric mean ratio	1.032 (95% CI 0.976–1.090)

Open in BENITIONS View on ClinicalTrials.gov

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Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage I — National Cancer Institute (NCI)
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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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