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NCT05388669 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Other-event reporting threshold
5%

Safety analysis set included all randomized participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

59 / 206201 / 20643 / 206
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.

64 / 210207 / 21061 / 210

Group identifiers: EG000: Arm A: Lazertinib With Amivantamab SC-CF · EG001: Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Acute Myocardial Infarction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Cardiac Arrest
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Ischaemic Cardiomyopathy
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Myocardial Infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Diplopia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Gastritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Haematemesis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Ileus
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Lower Gastrointestinal Haemorrhage

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      210
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      210
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      210
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      210
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      210
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      210
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      210
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      210
    term
    Gingival Bleeding
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      210
    term
    Haemorrhoids
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      210
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      210
    term
    Stomatitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      210
    term
    Vomiting
Complete source fields
description
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    43
    deaths Num At Risk
    206
    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
    EG000
    other Num Affected
    201
    other Num At Risk
    206
    serious Num Affected
    59
    serious Num At Risk
    206
    title
    Arm A: Lazertinib With Amivantamab SC-CF
  2. deaths Num Affected
    61
    deaths Num At Risk
    210
    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
    EG001
    other Num Affected
    207
    other Num At Risk
    210
    serious Num Affected
    64
    serious Num At Risk
    210
    title
    Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      210
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      210
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      210
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      210
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      210
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      210
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      210
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      210
    term
    Gingival Bleeding
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      210
    term
    Haemorrhoids
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      210
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      210
    term
    Stomatitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      210
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Acute Myocardial Infarction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Cardiac Arrest
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Ischaemic Cardiomyopathy
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Myocardial Infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Diplopia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Gastritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Haematemesis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      210
    term
    Ileus
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      210
    term
    Lower Gastrointestinal Haemorrhage
time Frame
All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months

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