NCT04487080 · ADVERSE EVENTS

Adverse events

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.

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 32.8 months
Other-event reporting threshold: 5%

The safety set included 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
Experimental: Arm A (Open-label): Amivantamab + Lazertinib 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.	205 / 421	419 / 421	96 / 421
Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib 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.	143 / 428	409 / 428	116 / 428
Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib 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.	75 / 213	210 / 213	56 / 213

Group identifiers: EG000: Experimental: Arm A (Open-label): Amivantamab + Lazertinib · EG001: Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib · EG002: Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
26
num At Risk
421
group Id
EG001
num Affected
10
num At Risk
428
group Id
EG002
num Affected
8
num At Risk
213
term
Pulmonary Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
9
num At Risk
421
group Id
EG001
num Affected
17
num At Risk
428
group Id
EG002
num Affected
3
num At Risk
213
term
Pleural Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
7
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
428
group Id
EG002
num Affected
3
num At Risk
213
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
6
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Respiratory Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
421
group Id
EG001
num Affected
5
num At Risk
428
group Id
EG002
num Affected
3
num At Risk
213
term
Interstitial Lung Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
11
num At Risk
428
group Id
EG002
num Affected
2
num At Risk
213
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Pneumothorax
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
0
num At Risk
213
term
Acute Respiratory Distress Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
0
num At Risk
213
term
Asthma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Chronic Obstructive Pulmonary Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
1
num At Risk
428
group Id
EG002
num Affected
0
num At Risk
213
term
Dyspnoea Exertional

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
260
num At Risk
421
group Id
EG001
num Affected
131
num At Risk
428
group Id
EG002
num Affected
95
num At Risk
213
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
122
num At Risk
421
group Id
EG001
num Affected
55
num At Risk
428
group Id
EG002
num Affected
45
num At Risk
213
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
99
num At Risk
421
group Id
EG001
num Affected
73
num At Risk
428
group Id
EG002
num Affected
36
num At Risk
213
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
67
num At Risk
421
group Id
EG001
num Affected
60
num At Risk
428
group Id
EG002
num Affected
38
num At Risk
213
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
40
num At Risk
421
group Id
EG001
num Affected
23
num At Risk
428
group Id
EG002
num Affected
5
num At Risk
213
term
Skin Fissures
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
27
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
428
group Id
EG002
num Affected
8
num At Risk
213
term
Rash Maculo-Papular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
24
num At Risk
421
group Id
EG001
num Affected
15
num At Risk
428
group Id
EG002
num Affected
13
num At Risk
213
term
Palmar-Plantar Erythrodysaesthesia Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
22
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
428
group Id
EG002
num Affected
4
num At Risk
213
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
15
num At Risk
421
group Id
EG001
num Affected
20
num At Risk
428
group Id
EG002
num Affected
27
num At Risk
213
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
288
num At Risk
421
group Id
EG001
num Affected
121
num At Risk
428
group Id
EG002
num Affected
61
num At Risk
213
term
Paronychia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
104
num At Risk
421
group Id
EG001
num Affected
97
num At Risk
428
group Id
EG002
num Affected
39
num At Risk
213
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
46
num At Risk
421
group Id
EG001
num Affected
7
num At Risk
428
group Id
EG002
num Affected
7
num At Risk
213
term
Conjunctivitis

Complete source fields

description

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

event Groups

deaths Num Affected
96
deaths Num At Risk
421
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
EG000
other Num Affected
419
other Num At Risk
421
serious Num Affected
205
serious Num At Risk
421
title
Experimental: Arm A (Open-label): Amivantamab + Lazertinib
deaths Num Affected
116
deaths Num At Risk
428
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
EG001
other Num Affected
409
other Num At Risk
428
serious Num Affected
143
serious Num At Risk
428
title
Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
deaths Num Affected
56
deaths Num At Risk
213
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
EG002
other Num Affected
210
other Num At Risk
213
serious Num Affected
75
serious Num At Risk
213
title
Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib

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
260
num At Risk
421
group Id
EG001
num Affected
131
num At Risk
428
group Id
EG002
num Affected
95
num At Risk
213
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
122
num At Risk
421
group Id
EG001
num Affected
55
num At Risk
428
group Id
EG002
num Affected
45
num At Risk
213
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
99
num At Risk
421
group Id
EG001
num Affected
73
num At Risk
428
group Id
EG002
num Affected
36
num At Risk
213
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
67
num At Risk
421
group Id
EG001
num Affected
60
num At Risk
428
group Id
EG002
num Affected
38
num At Risk
213
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
40
num At Risk
421
group Id
EG001
num Affected
23
num At Risk
428
group Id
EG002
num Affected
5
num At Risk
213
term
Skin Fissures
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
27
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
428
group Id
EG002
num Affected
8
num At Risk
213
term
Rash Maculo-Papular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
24
num At Risk
421
group Id
EG001
num Affected
15
num At Risk
428
group Id
EG002
num Affected
13
num At Risk
213
term
Palmar-Plantar Erythrodysaesthesia Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
22
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
428
group Id
EG002
num Affected
4
num At Risk
213
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
15
num At Risk
421
group Id
EG001
num Affected
20
num At Risk
428
group Id
EG002
num Affected
27
num At Risk
213
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
288
num At Risk
421
group Id
EG001
num Affected
121
num At Risk
428
group Id
EG002
num Affected
61
num At Risk
213
term
Paronychia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
104
num At Risk
421
group Id
EG001
num Affected
97
num At Risk
428
group Id
EG002
num Affected
39
num At Risk
213
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
46
num At Risk
421
group Id
EG001
num Affected
7
num At Risk
428
group Id
EG002
num Affected
7
num At Risk
213
term
Conjunctivitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
26
num At Risk
421
group Id
EG001
num Affected
10
num At Risk
428
group Id
EG002
num Affected
8
num At Risk
213
term
Pulmonary Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
9
num At Risk
421
group Id
EG001
num Affected
17
num At Risk
428
group Id
EG002
num Affected
3
num At Risk
213
term
Pleural Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
7
num At Risk
421
group Id
EG001
num Affected
8
num At Risk
428
group Id
EG002
num Affected
3
num At Risk
213
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
6
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Respiratory Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
421
group Id
EG001
num Affected
5
num At Risk
428
group Id
EG002
num Affected
3
num At Risk
213
term
Interstitial Lung Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
421
group Id
EG001
num Affected
11
num At Risk
428
group Id
EG002
num Affected
2
num At Risk
213
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
421
group Id
EG001
num Affected
2
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Pneumothorax
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
0
num At Risk
213
term
Acute Respiratory Distress Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
0
num At Risk
213
term
Asthma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Chronic Obstructive Pulmonary Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
0
num At Risk
428
group Id
EG002
num Affected
1
num At Risk
213
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA Version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
421
group Id
EG001
num Affected
1
num At Risk
428
group Id
EG002
num Affected
0
num At Risk
213
term
Dyspnoea Exertional

time Frame

From baseline (Day 1 of Cycle 1) up to 32.8 months

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

Preserved source evidence · Not medical advice