NCT04538664 · ADVERSE EVENTS

Adverse events

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.

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: From baseline (Day 1 of Cycle 1) up to 29 months
Other-event reporting threshold: 5%

The safety set included all randomized participants who received at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm B: Chemotherapy Alone 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.	48 / 155	149 / 155	42 / 155
Arm A: Amivantamab + Chemotherapy 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.	56 / 151	151 / 151	28 / 151

Group identifiers: EG000: Arm B: Chemotherapy Alone · EG001: Arm A: Amivantamab + Chemotherapy

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
155
group Id
EG001
num Affected
6
num At Risk
151
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
3
num At Risk
151
term
Covid-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
2
num At Risk
151
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
2
num At Risk
151
term
Rash Pustular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
2
num At Risk
151
term
Skin Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Covid-19 Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Pneumonia Viral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Postoperative Wound Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Appendicitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Enterocolitis Infectious

Other reported adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
12
num At Risk
155
group Id
EG001
num Affected
81
num At Risk
151
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
155
group Id
EG001
num Affected
47
num At Risk
151
term
Dermatitis Acneiform
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
6
num At Risk
155
group Id
EG001
num Affected
16
num At Risk
151
term
Dry Skin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
155
group Id
EG001
num Affected
13
num At Risk
151
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
12
num At Risk
155
group Id
EG001
num Affected
10
num At Risk
151
term
Pruritus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
10
num At Risk
151
term
Skin Ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
47
num At Risk
155
group Id
EG001
num Affected
60
num At Risk
151
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
65
num At Risk
155
group Id
EG001
num Affected
55
num At Risk
151
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
9
num At Risk
155
group Id
EG001
num Affected
38
num At Risk
151
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
19
num At Risk
155
group Id
EG001
num Affected
31
num At Risk
151
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
28
num At Risk
155
group Id
EG001
num Affected
31
num At Risk
151
term
Vomiting

Complete source fields

description

The safety set included all randomized participants who received at least 1 dose of study treatment.

event Groups

deaths Num Affected
42
deaths Num At Risk
155
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
EG000
other Num Affected
149
other Num At Risk
155
serious Num Affected
48
serious Num At Risk
155
title
Arm B: Chemotherapy Alone
deaths Num Affected
28
deaths Num At Risk
151
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
EG001
other Num Affected
151
other Num At Risk
151
serious Num Affected
56
serious Num At Risk
151
title
Arm A: Amivantamab + Chemotherapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
12
num At Risk
155
group Id
EG001
num Affected
81
num At Risk
151
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
155
group Id
EG001
num Affected
47
num At Risk
151
term
Dermatitis Acneiform
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
6
num At Risk
155
group Id
EG001
num Affected
16
num At Risk
151
term
Dry Skin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
155
group Id
EG001
num Affected
13
num At Risk
151
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
12
num At Risk
155
group Id
EG001
num Affected
10
num At Risk
151
term
Pruritus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
10
num At Risk
151
term
Skin Ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
47
num At Risk
155
group Id
EG001
num Affected
60
num At Risk
151
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
65
num At Risk
155
group Id
EG001
num Affected
55
num At Risk
151
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
9
num At Risk
155
group Id
EG001
num Affected
38
num At Risk
151
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
19
num At Risk
155
group Id
EG001
num Affected
31
num At Risk
151
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
28
num At Risk
155
group Id
EG001
num Affected
31
num At Risk
151
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
155
group Id
EG001
num Affected
6
num At Risk
151
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
3
num At Risk
151
term
Covid-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
2
num At Risk
151
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
2
num At Risk
151
term
Rash Pustular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
2
num At Risk
151
term
Skin Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Covid-19 Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Pneumonia Viral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Postoperative Wound Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Appendicitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Enterocolitis Infectious

time Frame

From baseline (Day 1 of Cycle 1) up to 29 months

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Preserved source evidence · Not medical advice