Participant flow

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.

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

   FG000

   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

   FG001

   title

   Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         156

      2. group Id

         FG001

         num Subjects

         141

      type

      Other-Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         212

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         210

      type

      Treated (Safety Analysis)

   3. achievements

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         62

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         163

      2. group Id

         FG001

         num Subjects

         150

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The results are currently reported for primary analysis till clinical cut-off date 03-Jan-2024. Upon completion of the open-label follow-up phase, participants were permitted to enter the long-term extension (LTE) phase. The LTE phase is ongoing and results will be published after the completion of the study.

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Preserved source evidence · Not medical advice