Participant flow

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions · 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 received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m\^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase.

   id

   FG000

   title

   Arm B: Chemotherapy Alone

2. description

   Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (\>=) 80 kilograms \[kg\]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase.

   id

   FG001

   title

   Arm A: Amivantamab + Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         106

      2. group Id

         FG001

         num Subjects

         115

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         155

      2. group Id

         FG001

         num Subjects

         153

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         155

      2. group Id

         FG001

         num Subjects

         151

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         28

      comment

      As per protocol, participants who died were also considered as completed.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         113

      2. group Id

         FG001

         num Subjects

         125

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Currently, the results are posted till cut-off date 03-May-2023. After completion of open-label extension (OLE) phase participant were allowed to enter the long-term extension (LTE) phase. LTE 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