Participant flow

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2026-08-28

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

groups

1. description

   Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.

   id

   FG000

   title

   Experimental: Arm A (Open-label): Amivantamab + Lazertinib

2. description

   Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.

   id

   FG001

   title

   Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib

3. description

   Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.

   id

   FG002

   title

   Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         18

      3. group Id

         FG002

         num Subjects

         13

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         313

      2. group Id

         FG001

         num Subjects

         297

      3. group Id

         FG002

         num Subjects

         149

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         429

      2. group Id

         FG001

         num Subjects

         429

      3. group Id

         FG002

         num Subjects

         216

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         421

      2. group Id

         FG001

         num Subjects

         428

      3. group Id

         FG002

         num Subjects

         213

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         113

      3. group Id

         FG002

         num Subjects

         54

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         335

      2. group Id

         FG001

         num Subjects

         316

      3. group Id

         FG002

         num Subjects

         162

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Currently, results posted till cut-off date 11-Aug-2023 (primary completion date). After analyzing primary analysis of progression free survival, participants were transitioned to an open-label extension (OLE) phase. Participants who continue to benefit from study treatment(s), as determined by investigator, may continue to receive access to study treatment(s) within study by transferring to long-term extension phase. OLE phase is still ongoing and results will be posted upon study completion.

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

Preserved source evidence · Not medical advice