A Study of Amivantamab and Lazertinib in Combination With... | NCT04988295

NCT04988295

ID	Type	Description
61186372NSC3002	Other Identifier	Janssen Research & Development, LLC
2021-001825-33	EudraCT Number
2023-506518-33-00	Registry Identifier	EUCT number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: LACP/ACP-L	Experimental	LACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.	Drug: Lazertinib Drug: Amivantamab Drug: Pemetrexed Drug: Carboplatin
Arm B: CP (Carboplatin and Pemetrexed)	Active Comparator	Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.	Drug: Pemetrexed Drug: Carboplatin
Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)	Experimental	Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.	Drug: Amivantamab Drug: Pemetrexed Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Lazertinib	Drug	Lazertinib will be administered orally.	Arm A2 (Extension Cohort): ACP-L Arm A: LACP/ACP-L

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)	PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum).	From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)
Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.	up to 4 years 10 months
Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review		Up to 4 years 10 months

Secondary Outcomes

Measure	Description	Time Frame
Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review		Up to 4 years 10 months
Main Study+ Extension Cohort: Overall Survival		Up to 4 years 10 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade <= 2 peripheral neuropathy, or Grade <= 2 hypothyroidism stable on hormone replacement)
A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)

Exclusion Criteria:

Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
Participant with symptomatic or progressive brain metastases
Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has known small cell transformation
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center, PC		Mobile	Alabama	36608	United States
Arizona Oncology Associates

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 5, 2024	Oct 16, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

JNJ-73841937
YH-25448

Only main study (N=657) results are reported, thus column "Total participants" presents main study data. Per protocol, extension cohort analysis was not included in main study primary analysis. Extension cohort results will be reported later, upon analysis completion, at which point arms A2 and C2 details will be reported. For reporting purpose of extension cohort at this time since data is still not available, single combined arm for extension cohort (A2/C2) is presented with '0' participants.

Arm/Group Information

ID	Title	Description
BG000	Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)	LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to [>=80] kilograms [kg]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight >=80] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg). Participant also received Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
BG001	Main Study: Arm B: Carboplatin + Pemetrexed (CP)	Participants received Pemetrexed 500 mg/m^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.
BG002	Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)	Participants received Amivantamab 1400 mg (1750 mg if body weight >=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
BG003	Extension Cohort: All Participants (Arm A2 [ACP-L] + C2 [ACP])	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.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.3± 10.96 BG00160.6± 10.13 BG00261.2± 10.06 BG004

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000168 BG001157 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00022 BG00123 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0013 BG002

Region of Enrollment

For extension cohort, data was not available at the time of primary analysis results reporting. Hence, enrollment data was reported only for main study.

Count of Participants

Participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG0005 BG0016

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum).

Full analysis set (FAS) as defined in the protocol included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received. The outcomes reported here are for main study participants. For Arm A participants, data were planned to be analyzed as a single arm collectively for the LACP and ACP-L dosing regimens.

Posted

Median

95% Confidence Interval

months

From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)

ID	Title	Description
OG000	Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)	LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to [>=80] kilograms [kg]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight >=80] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg). Participant also received Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
OG001	Main Study: Arm B: Carboplatin + Pemetrexed (CP)	Participants received Pemetrexed 500 mg/m^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.
OG002	Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)	Participants received Amivantamab 1400 mg (1750 mg if body weight >=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.

Units	Counts
Participants	OG000263 OG001263 OG002131

Title

Denominators

Categories

Title	Measurements
	OG0008.31(6.77 to 9.10) OG0014.17(4.04 to 4.44) OG0026.28(5.55 to 8.41)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.0001		Hazard Ratio (HR)	0.44			2-Sided	95	0.35	0.56					Superiority
OG001 OG002		Log Rank		<0.0001

Primary

Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.

Not Posted

Sep 2027

up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Overall Survival

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Time to Subsequent Therapy

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Time to Symptomatic Progression

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study: Number of Participants With Adverse Events (AEs)

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Serum Concentration of Amivantamab

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Plasma Concentration of Lazertinib

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study + Extension Cohort: Number of Participants With Serum Anti-amivantamab Antibodies

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Change From Baseline With Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Change From Baseline With European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Secondary

Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Primary

Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review

Not Posted

Sep 2027

Up to 4 years 10 months

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)	LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to [>=80] kilograms [kg]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight >=80] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg). Participant also received Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.	69	263	137	263	261	263
EG001	Main Study: Arm B: Carboplatin + Pemetrexed (CP)	Participants received Pemetrexed 500 mg/m^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.	65	263	49	243	222	243
EG002	Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)	Participants received Amivantamab 1400 mg (1750 mg if body weight >=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight >=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.	27	131	42	130	129	130

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sepsis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0006 affected263 at risk EG0011 affected243 at risk EG0023 affected130 at risk
Covid-19	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0006 affected263 at risk EG0010 affected243 at risk EG0022 affected130 at risk
Skin Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0022 affected130 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Herpes Virus Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Infectious Pleural Effusion	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Pneumonia Viral	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Soft Tissue Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Bacteraemia	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Bacterial Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Cellulitis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Conjunctivitis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Coronavirus Pneumonia	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Covid-19 Pneumonia	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Enterocolitis Infectious	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Erysipelas	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Folliculitis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Influenza	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Meningitis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Paronychia	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Pneumonia	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0008 affected263 at risk EG0015 affected243 at risk EG0020 affected130 at risk
Pneumonia Pneumococcal	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0012 affected243 at risk EG0020 affected130 at risk
Septic Shock	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Urosepsis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0012 affected243 at risk EG0024 affected130 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0013 affected243 at risk EG0023 affected130 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0013 affected243 at risk EG0021 affected130 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0007 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0021 affected130 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Respiratory Acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00022 affected263 at risk EG0015 affected243 at risk EG0024 affected130 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0008 affected263 at risk EG0012 affected243 at risk EG0022 affected130 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00020 affected263 at risk EG0015 affected243 at risk EG0022 affected130 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0022 affected130 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00021 affected263 at risk EG0016 affected243 at risk EG0022 affected130 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00010 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0008 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0005 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0007 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Gastrointestinal Ulcer	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Haematemesis	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Pyrexia	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0013 affected243 at risk EG0022 affected130 at risk
Fatigue	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0021 affected130 at risk
Oedema Peripheral	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Asthenia	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0012 affected243 at risk EG0020 affected130 at risk
General Physical Health Deterioration	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Localised Oedema	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Malaise	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Pain	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Sudden Death	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0022 affected130 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0009 affected263 at risk EG0010 affected243 at risk EG0022 affected130 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Gastrointestinal Injury	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0011 affected243 at risk EG0022 affected130 at risk
Embolism	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Hypotension	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Thrombophlebitis	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Venous Thrombosis	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Drug-Induced Liver Injury	Hepatobiliary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Hepatic Cytolysis	Hepatobiliary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0012 affected243 at risk EG0020 affected130 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
C-Reactive Protein Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
General Physical Condition Abnormal	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Troponin I Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0003 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Cerebral Infarction	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0021 affected130 at risk
Optic Neuritis	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Depressed Level of Consciousness	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Dizziness	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Dysarthria	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Dyskinesia	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Epilepsy	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Headache	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Hypersomnia	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Seizure	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Subdural Hygroma	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Syncope	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0011 affected243 at risk EG0021 affected130 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Bladder Dilatation	Renal and urinary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0005 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Aseptic Pustule	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0004 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Skin Toxicity	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Confusional State	Psychiatric disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0000 affected263 at risk EG0011 affected243 at risk EG0020 affected130 at risk
Delirium	Psychiatric disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk
Disorientation	Psychiatric disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0001 affected263 at risk EG0010 affected243 at risk EG0020 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000130 affected263 at risk EG00190 affected243 at risk EG00258 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00096 affected263 at risk EG00172 affected243 at risk EG00250 affected130 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000120 affected263 at risk EG00121 affected243 at risk EG00241 affected130 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00075 affected263 at risk EG00142 affected243 at risk EG00231 affected130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00066 affected263 at risk EG00116 affected243 at risk EG00217 affected130 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00013 affected263 at risk EG0016 affected243 at risk EG0027 affected130 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0006 affected263 at risk EG0011 affected243 at risk EG0027 affected130 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00022 affected263 at risk EG0011 affected243 at risk EG0027 affected130 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000173 affected263 at risk EG00198 affected243 at risk EG00273 affected130 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000156 affected263 at risk EG00169 affected243 at risk EG00257 affected130 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000141 affected263 at risk EG00196 affected243 at risk EG00250 affected130 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000106 affected263 at risk EG00167 affected243 at risk EG00237 affected130 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00036 affected263 at risk EG00120 affected243 at risk EG00212 affected130 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000125 affected263 at risk EG00112 affected243 at risk EG00256 affected130 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00062 affected263 at risk EG0017 affected243 at risk EG00226 affected130 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00030 affected263 at risk EG00117 affected243 at risk EG00220 affected130 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00022 affected263 at risk EG0014 affected243 at risk EG00215 affected130 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00010 affected263 at risk EG0018 affected243 at risk EG0028 affected130 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00016 affected263 at risk EG0014 affected243 at risk EG0023 affected130 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00015 affected263 at risk EG0010 affected243 at risk EG0021 affected130 at risk
Oedema Peripheral	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00085 affected263 at risk EG00115 affected243 at risk EG00242 affected130 at risk
Fatigue	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00069 affected263 at risk EG00147 affected243 at risk EG00235 affected130 at risk
Asthenia	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00067 affected263 at risk EG00139 affected243 at risk EG00234 affected130 at risk
Pyrexia	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00029 affected263 at risk EG00124 affected243 at risk EG00213 affected130 at risk
Malaise	General disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00017 affected263 at risk EG00110 affected243 at risk EG0025 affected130 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA Version 25.0	Non-systematic Assessment	EG000142 affected263 at risk EG0011 affected243 at risk EG00274 affected130 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00085 affected263 at risk EG00150 affected243 at risk EG00240 affected130 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG000104 affected263 at risk EG00121 affected243 at risk EG00229 affected130 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00054 affected263 at risk EG00115 affected243 at risk EG00224 affected130 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00023 affected263 at risk EG00110 affected243 at risk EG00216 affected130 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00044 affected263 at risk EG0019 affected243 at risk EG00216 affected130 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00033 affected263 at risk EG0019 affected243 at risk EG00213 affected130 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00040 affected263 at risk EG00116 affected243 at risk EG00213 affected130 at risk
Paronychia	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG000132 affected263 at risk EG0011 affected243 at risk EG00248 affected130 at risk
Covid-19	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG00039 affected263 at risk EG00125 affected243 at risk EG00225 affected130 at risk
Conjunctivitis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG00011 affected263 at risk EG0015 affected243 at risk EG00210 affected130 at risk
Folliculitis	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0009 affected263 at risk EG0010 affected243 at risk EG0028 affected130 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG0006 affected263 at risk EG0014 affected243 at risk EG0028 affected130 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 25.0	Non-systematic Assessment	EG00022 affected263 at risk EG0016 affected243 at risk EG0023 affected130 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG00055 affected263 at risk EG00167 affected243 at risk EG00226 affected130 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG00043 affected263 at risk EG00157 affected243 at risk EG00219 affected130 at risk
Weight Decreased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG00031 affected263 at risk EG00117 affected243 at risk EG00214 affected130 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG00024 affected263 at risk EG00113 affected243 at risk EG0029 affected130 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG00026 affected263 at risk EG00125 affected243 at risk EG0027 affected130 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 25.0	Non-systematic Assessment	EG00031 affected263 at risk EG00114 affected243 at risk EG0024 affected130 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00023 affected263 at risk EG00129 affected243 at risk EG00214 affected130 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00015 affected263 at risk EG00117 affected243 at risk EG00212 affected130 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00035 affected263 at risk EG0017 affected243 at risk EG00211 affected130 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0009 affected263 at risk EG00113 affected243 at risk EG0024 affected130 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00028 affected263 at risk EG0016 affected243 at risk EG0024 affected130 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00023 affected263 at risk EG00118 affected243 at risk EG00213 affected130 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00011 affected263 at risk EG0017 affected243 at risk EG00212 affected130 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00016 affected263 at risk EG0019 affected243 at risk EG0028 affected130 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 25.0	Non-systematic Assessment	EG0002 affected263 at risk EG0012 affected243 at risk EG0027 affected130 at risk
Headache	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00023 affected263 at risk EG00128 affected243 at risk EG00211 affected130 at risk
Dizziness	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00032 affected263 at risk EG00115 affected243 at risk EG00210 affected130 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00022 affected263 at risk EG0016 affected243 at risk EG0025 affected130 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00017 affected263 at risk EG0018 affected243 at risk EG0024 affected130 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00019 affected263 at risk EG0016 affected243 at risk EG0023 affected130 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00019 affected263 at risk EG0013 affected243 at risk EG0028 affected130 at risk
Hypotension	Vascular disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00016 affected263 at risk EG0015 affected243 at risk EG0023 affected130 at risk
Insomnia	Psychiatric disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00015 affected263 at risk EG0017 affected243 at risk EG00210 affected130 at risk
Dry Eye	Eye disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00012 affected263 at risk EG0012 affected243 at risk EG0027 affected130 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 25.0	Non-systematic Assessment	EG00018 affected263 at risk EG0012 affected243 at risk EG0021 affected130 at risk

First MCP Posted Date

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C000707992	lazertinib
C000718215	amivantamab
D000068437	Pemetrexed
D016190	Carboplatin

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D056831	Coordination Complexes
D009930	Organic Chemicals