Trial Outcomes & Findings for 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 (NCT NCT04538664)

NCT ID: NCT04538664

Last Updated: 2025-11-13

Results Overview

PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: 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).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 308 participants
• Primary outcome timeframe: From randomization to either disease progression or death whichever occurs first (up to 29 months)
• Results posted on: 2025-11-13

Participant Flow

Currently, the results are posted till cut-off date 03-May-2023. After completion of open-label extension (OLE) phase participant were allowed to enter the long-term extension (LTE) phase. LTE phase is still ongoing and results will be posted upon study completion.

Participant milestones

Measure	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.	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.
Overall Study STARTED	155	153
Overall Study Treated	155	151
Overall Study COMPLETED	42	28
Overall Study NOT COMPLETED	113	125

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	5	9
Overall Study Lost to Follow-up	2	1
Overall Study Ongoing	106	115

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm B: Chemotherapy Alone n=155 Participants 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.	Arm A: Amivantamab + Chemotherapy n=153 Participants 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.	Total n=308 Participants Total of all reporting groups
Sex: Female, Male Female	93 Participants n=10 Participants	85 Participants n=10 Participants	178 Participants n=20 Participants
Age, Continuous	60 years STANDARD_DEVIATION 12.01 • n=10 Participants	59.3 years STANDARD_DEVIATION 11.92 • n=10 Participants	59.6 years STANDARD_DEVIATION 11.95 • n=20 Participants
Sex: Female, Male Male	62 Participants n=10 Participants	68 Participants n=10 Participants	130 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=10 Participants	13 Participants n=10 Participants	22 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=10 Participants	137 Participants n=10 Participants	282 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Race (NIH/OMB) Asian	89 Participants n=10 Participants	97 Participants n=10 Participants	186 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) White	60 Participants n=10 Participants	49 Participants n=10 Participants	109 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=10 Participants	3 Participants n=10 Participants	7 Participants n=20 Participants
Region of Enrollment AUSTRALIA	4 Participants n=10 Participants	2 Participants n=10 Participants	6 Participants n=20 Participants
Region of Enrollment BELGIUM	1 Participants n=10 Participants	2 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment BRAZIL	5 Participants n=10 Participants	6 Participants n=10 Participants	11 Participants n=20 Participants
Region of Enrollment CANADA	3 Participants n=10 Participants	5 Participants n=10 Participants	8 Participants n=20 Participants
Region of Enrollment CHINA	48 Participants n=10 Participants	39 Participants n=10 Participants	87 Participants n=20 Participants
Region of Enrollment FRANCE	4 Participants n=10 Participants	3 Participants n=10 Participants	7 Participants n=20 Participants
Region of Enrollment GERMANY	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Region of Enrollment HUNGARY	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Region of Enrollment INDIA	6 Participants n=10 Participants	5 Participants n=10 Participants	11 Participants n=20 Participants
Region of Enrollment ISRAEL	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment ITALY	5 Participants n=10 Participants	7 Participants n=10 Participants	12 Participants n=20 Participants
Region of Enrollment JAPAN	15 Participants n=10 Participants	19 Participants n=10 Participants	34 Participants n=20 Participants
Region of Enrollment MALAYSIA	1 Participants n=10 Participants	10 Participants n=10 Participants	11 Participants n=20 Participants
Region of Enrollment MEXICO	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment POLAND	2 Participants n=10 Participants	4 Participants n=10 Participants	6 Participants n=20 Participants
Region of Enrollment PORTUGAL	3 Participants n=10 Participants	1 Participants n=10 Participants	4 Participants n=20 Participants
Region of Enrollment RUSSIAN FEDERATION	3 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants
Region of Enrollment SOUTH KOREA	10 Participants n=10 Participants	13 Participants n=10 Participants	23 Participants n=20 Participants
Region of Enrollment SPAIN	13 Participants n=10 Participants	16 Participants n=10 Participants	29 Participants n=20 Participants
Region of Enrollment TAIWAN	5 Participants n=10 Participants	4 Participants n=10 Participants	9 Participants n=20 Participants
Region of Enrollment THAILAND	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Region of Enrollment TURKEY	10 Participants n=10 Participants	3 Participants n=10 Participants	13 Participants n=20 Participants
Region of Enrollment UNITED KINGDOM	3 Participants n=10 Participants	1 Participants n=10 Participants	4 Participants n=20 Participants
Region of Enrollment UNITED STATES	8 Participants n=10 Participants	8 Participants n=10 Participants	16 Participants n=20 Participants

PRIMARY outcome

Timeframe: From randomization to either disease progression or death whichever occurs first (up to 29 months)

Population: Full analysis set included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.

PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: 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).

Outcome measures

Measure	Arm B: Chemotherapy Alone n=155 Participants 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.	Arm A: Amivantamab + Chemotherapy n=153 Participants 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.
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)	6.70 Months Interval 5.59 to 7.33	11.37 Months Interval 9.79 to 13.7

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 to 5 years 2 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 to 5 years 2 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 5 years 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 5 years 3 months

Outcome measures

Outcome data not reported

Adverse Events

Arm B: Chemotherapy Alone

Serious events: 48 serious events

Other events: 149 other events

Deaths: 42 deaths

Arm A: Amivantamab + Chemotherapy

Serious events: 56 serious events

Other events: 151 other events

Deaths: 28 deaths

Serious adverse events

Measure	Arm B: Chemotherapy Alone n=155 participants at risk 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.	Arm A: Amivantamab + Chemotherapy n=151 participants at risk 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.
Infections and infestations Pneumonia	2.6% 4/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	4.0% 6/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Covid-19	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.0% 3/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Cellulitis	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Rash Pustular	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Skin Infection	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Enterocolitis	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Asthenia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Death	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Fatigue	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Covid-19 Pneumonia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Infection	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia Viral	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Postoperative Wound Infection	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Sepsis	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Appendicitis	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Enterocolitis Infectious	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.0% 3/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Duodenitis	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Ascites	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.6% 4/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.6% 4/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.6% 4/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 5/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.2% 5/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.0% 3/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypophagia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Malnutrition	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	3.2% 5/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.0% 3/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	3.9% 6/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Febrile Neutropenia	1.9% 3/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Myelosuppression	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	1.3% 2/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebrovascular Accident	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Encephalopathy	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Myoclonic Epilepsy	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Depressed Level of Consciousness	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dysarthria	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Lacunar Infarction	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Syncope	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Vertebrobasilar Insufficiency	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders General Physical Health Deterioration	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Influenza Like Illness	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Pain	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Alanine Aminotransferase Increased	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Blood Creatinine Increased	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations C-Reactive Protein Increased	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Aspartate Aminotransferase Increased	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Femur Fracture	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Incisional Hernia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Bone Pain	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Endometrial Thickening	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Ovarian Mass	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Acute Myocardial Infarction	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Pericardial Effusion	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Biliary Obstruction	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Jaundice Cholestatic	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Immune system disorders Contrast Media Reaction	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Ear and labyrinth disorders Hypoacusis	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.

Other adverse events

Measure	Arm B: Chemotherapy Alone n=155 participants at risk 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.	Arm A: Amivantamab + Chemotherapy n=151 participants at risk 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.
Gastrointestinal disorders Haemorrhoids	1.3% 2/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	11.9% 18/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Malaise	7.7% 12/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	10.6% 16/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Mucosal Inflammation	2.6% 4/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	9.9% 15/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Oedema	1.3% 2/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Paronychia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	56.3% 85/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Covid-19	12.9% 20/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	21.9% 33/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	8.6% 13/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Conjunctivitis	4.5% 7/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.0% 9/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Erythema	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Constipation	30.3% 47/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	39.7% 60/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	41.9% 65/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	36.4% 55/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Stomatitis	5.8% 9/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	25.2% 38/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	12.3% 19/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	20.5% 31/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	18.1% 28/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	20.5% 31/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	7.7% 12/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	53.6% 81/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	3.2% 5/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	31.1% 47/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dry Skin	3.9% 6/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	10.6% 16/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	8.6% 13/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	7.7% 12/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Skin Ulcer	0.65% 1/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Mouth Ulceration	2.6% 4/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	7.9% 12/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain	2.6% 4/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gingival Bleeding	1.3% 2/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	5.3% 8/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Distension	6.5% 10/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	4.6% 7/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain Upper	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.6% 4/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	9.7% 15/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	41.1% 62/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased Appetite	27.7% 43/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	35.8% 54/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	8.4% 13/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	21.2% 32/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	9.7% 15/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	14.6% 22/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	1.9% 3/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	12.6% 19/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	7.7% 12/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	11.9% 18/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	1.3% 2/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoproteinaemia	1.9% 3/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	7.1% 11/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	5.3% 8/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	5.3% 8/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	45.2% 70/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	58.3% 88/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	54.2% 84/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	50.3% 76/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Leukopenia	32.3% 50/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	37.1% 56/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	29.7% 46/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	36.4% 55/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Lymphopenia	7.1% 11/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	4.6% 7/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Oedema Peripheral	10.3% 16/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	29.8% 45/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Asthenia	18.1% 28/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	19.2% 29/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Pyrexia	5.8% 9/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	15.9% 24/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
General disorders Fatigue	20.6% 32/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	15.2% 23/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Upper Respiratory Tract Infection	3.9% 6/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.0% 9/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Urinary Tract Infection	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	4.0% 6/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Alanine Aminotransferase Increased	36.1% 56/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	33.1% 50/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Aspartate Aminotransferase Increased	32.3% 50/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	31.1% 47/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Gamma-Glutamyltransferase Increased	16.8% 26/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	13.9% 21/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Weight Decreased	8.4% 13/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	13.9% 21/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Blood Alkaline Phosphatase Increased	7.7% 12/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	12.6% 19/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Blood Lactate Dehydrogenase Increased	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	8.6% 13/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Investigations Blood Creatinine Increased	9.0% 14/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	7.3% 11/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Infusion Related Reaction	1.3% 2/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	41.7% 63/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	15.5% 24/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	13.9% 21/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.9% 20/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	10.6% 16/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.6% 4/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	7.3% 11/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive Cough	1.9% 3/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.0% 9/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	9.7% 15/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	9.9% 15/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dysgeusia	6.5% 10/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.0% 9/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	8.4% 13/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.0% 9/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back Pain	10.3% 16/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	11.3% 17/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.4% 13/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Insomnia	12.9% 20/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	10.6% 16/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	3.9% 6/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	9.9% 15/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Vascular disorders Deep Vein Thrombosis	1.9% 3/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	6.6% 10/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Vascular disorders Hypertension	6.5% 10/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	0.66% 1/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.
Eye disorders Lacrimation Increased	5.2% 8/155 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.	2.0% 3/151 • From baseline (Day 1 of Cycle 1) up to 29 months The safety set included all randomized participants who received at least 1 dose of study treatment.

Additional Information

Executive Medical Director

Janssen Research & Development

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
• Publication restrictions are in place

Restriction type: OTHER