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

Фаза 3 Идёт, набор закрыт NCT05388669

Заболевание	Advanced or Metastatic Non-small Cell Lung Cancer
Фаза	Фаза 3
Спонсор	Janssen Research & Development, LLC
Статус	Идёт, набор закрыт
Участники	418 участн.
Вмешательство	Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous
Дата начала	5.08.2022
Дата завершения	3.01.2024
Публикация результатов	2.02.2026

Кратко

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)

Открыть в BENITIONS Открыть на ClinicalTrials.gov

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Все исследования

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