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
第3相
実施中（募集終了）
NCT05388669
| 対象疾患 | Advanced or Metastatic Non-small Cell Lung Cancer |
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| 相 | 第3相 |
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| スポンサー | Janssen Research & Development, LLC |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 418 名 |
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| 介入（薬剤） | Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous |
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| 開始日 | 2022年8月5日 |
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| 完了日 | 2024年1月3日 |
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| 結果公開日 | 2026年2月2日 |
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概要
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) |
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| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 144 ± 41.5 micrograms per milliliters (mcg/mL) |
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| Cox regression model | 1.427 (95% CI 1.266–1.610) |
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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 |
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| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 293 ± 31.7 mcg/mL |
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| Cox regression model | 1.145 (95% CI 1.040–1.261) |
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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 |
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| Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion | 131704 ± 24.0 micrograms*hour per milliliters |
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| Geometric mean ratio | 1.032 (95% CI 0.976–1.090) |
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