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

3期进行中（已停止招募） NCT05388669

适应症	Advanced or Metastatic Non-small Cell Lung Cancer
分期	3期
申办方	Janssen Research & Development, LLC
状态	进行中（已停止招募）
受试者人数	418 人
干预（药物）	Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous
开始日期	2022年8月5日
完成日期	2024年1月3日
结果公布日	2026年2月2日

摘要

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)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

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全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

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