Participant flow

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure · Source last updated 2026-08-20

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

groups

1. description

   Schedule 1:LACP:study start to 06-Nov-2022:Lazertinib 240 milligrams(mg) orally daily along with amivantamab and chemotherapy (carboplatin and pemetrexed). Amivantamab 1400 mg (1750 mg if body weight\>= 80 kilograms\[kg\]) intravenous(IV) infusion on Cycle 1 Days 1/2, 8 and 15 and Cycle 2 Day 1 and then 1750 mg (2100 mg if body weight \>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants received chemotherapy:pemetrexed 500 milligrams per meter square(mg/m\^2) IV infusion on Day 1 of each 21-day cycle, along with carboplatin area under concentration-time curve of 5 (AUC 5) IV infusion on Day 1 for up to 4 cycles and then as maintenance monotherapy until disease progression(DP). Schedule 2:ACP-L:07-Nov-2022 to study end:Amivantamab 1400 mg (1750 mg if body weight\>=80 kg) IV infusion on Cycle 1 Days 1/2, 8 and 15 and Cycle 2 Day 1 and then 1750 mg (2100 mg if body weight \>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants also received chemotherapy:pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle, along with carboplatin AUC 5 IV infusion on Day 1 for up to 4 cycles and then as maintenance monotherapy until DP. Lazertinib was administered 240 mg orally, once daily starting Cycle 5 Day 1 or sooner if carboplatin was discontinued earlier. In both schedules, Lazertinib, amivantamab and pemetrexed:continued until DP, participant withdrawal, adverse event, investigator's decision/initiation of new systemic anti-cancer treatment.

   id

   FG000

   title

   Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)

2. description

   Participants received chemotherapy with pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 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, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.

   id

   FG001

   title

   Main Study: Arm B: Carboplatin + Pemetrexed (CP)

3. description

   Participants received amivantamab 1400 mg (1750 mg if body weight is \>= 80 kg) by IV infusion once weekly starting from Cycle 1 Days 1/2, 8, and 15, and 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. Participants also received chemotherapy with pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 mg/mL per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles. Amivantamab and pemetrexed treatments were to be continued until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.

   id

   FG002

   title

   Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)

4. description

   In Arm A2, participants received amivantamab 1400 mg (1750 mg if body weight\>=80 kg) IV infusion once weekly from Cycle 1 Days 1/2, 8, and 15, and Cycle 2 Day 1, and then 1750 mg (2100 mg if body weight \>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants also received chemotherapy: pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under concentration-time curve of 5 mg/mL per minute (AUC 5) IV infusion administered on Day 1 for up to 4 cycles. Lazertinib was administered 240 mg orally, once daily starting Cycle 5 Day 1 or sooner if carboplatin was discontinued earlier. Amivantamab, pemetrexed and lazertinib were to be continued until disease progression (DP), participant withdrawal, adverse event (AE), investigator's decision or initiation of new systemic anti-cancer treatment. In Arm C2, participants received amivantamab 1400 mg (1750 mg if body weight \>=80 kg) IV infusion once weekly from Cycle 1 Days 1/2, 8, and 15, and 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. Participants also received chemotherapy: pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin AUC 5 IV infusion was administered on Day 1, for up to 4 cycles. Amivantamab and pemetrexed were to be continued until DP, participant withdrawal, AE, investigator's decision or initiation of new systemic anti-cancer treatment.

   id

   FG003

   title

   Extension Cohort: All Participants (Arm A2 [ACP-L] + C2 [ACP])

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         29

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         186

      2. group Id

         FG001

         num Subjects

         169

      3. group Id

         FG002

         num Subjects

         99

      4. group Id

         FG003

         num Subjects

         119

      type

      Study participation ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         263

      2. group Id

         FG001

         num Subjects

         263

      3. group Id

         FG002

         num Subjects

         131

      4. group Id

         FG003

         num Subjects

         119

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         263

      2. group Id

         FG001

         num Subjects

         243

      3. group Id

         FG002

         num Subjects

         130

      4. group Id

         FG003

         num Subjects

         119

      type

      Treated (Safety Analysis Set)

   3. achievements

      1. group Id

         FG000

         num Subjects

         67

      2. group Id

         FG001

         num Subjects

         65

      3. group Id

         FG002

         num Subjects

         26

      4. group Id

         FG003

         num Subjects

         0

      comment

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

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         198

      3. group Id

         FG002

         num Subjects

         105

      4. group Id

         FG003

         num Subjects

         119

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

At the time of PCD, extension cohort enrollment was still ongoing. As per protocol, extension cohort analysis was not included as part of main study primary analysis. Currently no information other than total count of participants for extension cohort is available and for reporting purpose extension cohort arms (A2 and C2) have been combined in the table. Results of extension cohort will be reported later, upon completion of analysis, at which point arms A2 and C2 details will be reported.

recruitment Details

A total of 657 participants were enrolled in the main study. During the study, a separate open-label randomized extension cohort was added. A total of 119 participants were enrolled into the extension cohort. Main study results are alone reported for primary completion date (PCD; 10-July-2023).

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Preserved source evidence · Not medical advice