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NCT05388669 · OUTCOME

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

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 · Source last updated 2026-08-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
micrograms*hour per milliliters
Interval / dispersion
Geometric Coefficient of Variation
Time frame
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

What was measured

AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.

Analysis population: The PK primary endpoint evaluable set included all randomized participants who had received all doses up to Cycle 2 Day 1, without dose modifications and provided all necessary PK samples to derive primary PK endpoint Cycle 2 AUC(D1-D15). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Groups in this outcome

Arm A: Lazertinib With Amivantamab SC-CF

Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.

Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion

Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A: Lazertinib With Amivantamab SC-CF140
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion132

Reported measurements

Source class 1
Values in micrograms*hour per milliliters · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Lazertinib With Amivantamab SC-CF13586130.7Not reportedNot reportedNot reported
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion13170424.0Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.976
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.090
    group Description
    Arm B Vs Arm A
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The primary hypothesis tests was based on one-sided test at significance level of alpha = 0.05 to demonstrate the non-inferiority of the amivantamab SC-CF relative to amivantamab IV.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Geometric mean ratio
    param Value
    1.032
Complete source fields
analyses
  1. ci Lower Limit
    0.976
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.090
    group Description
    Arm B Vs Arm A
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The primary hypothesis tests was based on one-sided test at significance level of alpha = 0.05 to demonstrate the non-inferiority of the amivantamab SC-CF relative to amivantamab IV.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Geometric mean ratio
    param Value
    1.032
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.7
        value
        135861
      2. group Id
        OG001
        spread
        24.0
        value
        131704
denoms
  1. counts
    1. group Id
      OG000
      value
      140
    2. group Id
      OG001
      value
      132
    units
    Participants
description
AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
    id
    OG000
    title
    Arm A: Lazertinib With Amivantamab SC-CF
  2. description
    Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
    id
    OG001
    title
    Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
param Type
GEOMETRIC_MEAN
population Description
The PK primary endpoint evaluable set included all randomized participants who had received all doses up to Cycle 2 Day 1, without dose modifications and provided all necessary PK samples to derive primary PK endpoint Cycle 2 AUC(D1-D15). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
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
title
Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
type
PRIMARY
unit Of Measure
micrograms*hour per milliliters

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice