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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 (PAPILLON)

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ClinicalTrials.gov Identifier: NCT04538664
Recruitment Status : Active, not recruiting
First Posted : September 4, 2020
Results First Posted : May 29, 2024
Last Update Posted : June 20, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: Amivantamab
Drug: Pemetrexed
Drug: Carboplatin
Enrollment 308
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy
Hide Arm/Group Description Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase. 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.
Period Title: Overall Study
Started 155 153
Treated 155 151
Completed [1] 42 28
Not Completed 113 125
Reason Not Completed
Withdrawal by Subject             5             9
Lost to Follow-up             2             1
Ongoing             106             115
[1]
As per protocol, participants who died were also considered as completed.
Arm/Group Title Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy Total
Hide Arm/Group Description Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase. 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 of all reporting groups
Overall Number of Baseline Participants 155 153 308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 153 participants 308 participants
60  (12.01) 59.3  (11.92) 59.6  (11.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
Female
93
  60.0%
85
  55.6%
178
  57.8%
Male
62
  40.0%
68
  44.4%
130
  42.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
Hispanic or Latino
9
   5.8%
13
   8.5%
22
   7.1%
Not Hispanic or Latino
145
  93.5%
137
  89.5%
282
  91.6%
Unknown or Not Reported
1
   0.6%
3
   2.0%
4
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
American Indian or Alaska Native
2
   1.3%
1
   0.7%
3
   1.0%
Asian
89
  57.4%
97
  63.4%
186
  60.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   1.3%
2
   0.6%
White
60
  38.7%
49
  32.0%
109
  35.4%
More than one race
0
   0.0%
1
   0.7%
1
   0.3%
Unknown or Not Reported
4
   2.6%
3
   2.0%
7
   2.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
AUSTRALIA
4
   2.6%
2
   1.3%
6
   1.9%
BELGIUM
1
   0.6%
2
   1.3%
3
   1.0%
BRAZIL
5
   3.2%
6
   3.9%
11
   3.6%
CANADA
3
   1.9%
5
   3.3%
8
   2.6%
CHINA
48
  31.0%
39
  25.5%
87
  28.2%
FRANCE
4
   2.6%
3
   2.0%
7
   2.3%
GERMANY
2
   1.3%
0
   0.0%
2
   0.6%
HUNGARY
0
   0.0%
1
   0.7%
1
   0.3%
INDIA
6
   3.9%
5
   3.3%
11
   3.6%
ISRAEL
2
   1.3%
1
   0.7%
3
   1.0%
ITALY
5
   3.2%
7
   4.6%
12
   3.9%
JAPAN
15
   9.7%
19
  12.4%
34
  11.0%
MALAYSIA
1
   0.6%
10
   6.5%
11
   3.6%
MEXICO
2
   1.3%
1
   0.7%
3
   1.0%
POLAND
2
   1.3%
4
   2.6%
6
   1.9%
PORTUGAL
3
   1.9%
1
   0.7%
4
   1.3%
RUSSIAN FEDERATION
3
   1.9%
0
   0.0%
3
   1.0%
SOUTH KOREA
10
   6.5%
13
   8.5%
23
   7.5%
SPAIN
13
   8.4%
16
  10.5%
29
   9.4%
TAIWAN
5
   3.2%
4
   2.6%
9
   2.9%
THAILAND
0
   0.0%
2
   1.3%
2
   0.6%
TURKEY
10
   6.5%
3
   2.0%
13
   4.2%
UNITED KINGDOM
3
   1.9%
1
   0.7%
4
   1.3%
UNITED STATES
8
   5.2%
8
   5.2%
16
   5.2%
1.Primary Outcome
Title Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Hide Description 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).
Time Frame From randomization to either disease progression or death whichever occurs first (up to 29 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.
Arm/Group Title Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy
Hide Arm/Group Description:
Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase.
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 Number of Participants Analyzed 155 153
Median (95% Confidence Interval)
Unit of Measure: Months
6.70
(5.59 to 7.33)
11.37
(9.79 to 13.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B: Chemotherapy Alone, Arm A: Amivantamab + Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.395
Confidence Interval (2-Sided) 95%
0.296 to 0.528
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Duration of Response (DoR)
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Subsequent Therapy (TST)
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Progression-Free Survival After First Subsequent Therapy (PFS2)
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Symptomatic Progression (TTSP)
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Number of Participants Treatment-emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame From Day 1 to 5 years 2 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Participants TEAEs With Severity
Hide Description [Not Specified]
Time Frame From Day 1 to 5 years 2 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants With Vital Signs Abnormalities
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Participants With Physical Examination Abnormalities
Hide Description [Not Specified]
Time Frame Up to 5 years 3 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Serum Concentration of Amivantamab
Hide Description [Not Specified]
Time Frame Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Number of Participants With Anti-Amivantamab Antibodies
Hide Description [Not Specified]
Time Frame Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Hide Description [Not Specified]
Time Frame From baseline to 5 years 3 months
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Hide Description [Not Specified]
Time Frame From baseline to 5 years 3 months
Outcome Measure Data Not Reported
Time Frame From baseline (Day 1 of Cycle 1) up to 29 months
Adverse Event Reporting Description The safety set included all randomized participants who received at least 1 dose of study treatment.
 
Arm/Group Title Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy
Hide Arm/Group Description Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase. 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.
All-Cause Mortality
Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   42/155 (27.10%)   28/151 (18.54%) 
Hide Serious Adverse Events
Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   48/155 (30.97%)   56/151 (37.09%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  5/155 (3.23%)  3/151 (1.99%) 
Neutropenia * 1  0/155 (0.00%)  2/151 (1.32%) 
Anaemia * 1  6/155 (3.87%)  1/151 (0.66%) 
Febrile Neutropenia * 1  3/155 (1.94%)  1/151 (0.66%) 
Leukopenia * 1  0/155 (0.00%)  1/151 (0.66%) 
Myelosuppression * 1  1/155 (0.65%)  0/151 (0.00%) 
Cardiac disorders     
Cardio-Respiratory Arrest * 1  0/155 (0.00%)  1/151 (0.66%) 
Acute Myocardial Infarction * 1  1/155 (0.65%)  0/151 (0.00%) 
Pericardial Effusion * 1  1/155 (0.65%)  0/151 (0.00%) 
Ear and labyrinth disorders     
Hypoacusis * 1  1/155 (0.65%)  0/151 (0.00%) 
Gastrointestinal disorders     
Vomiting * 1  1/155 (0.65%)  3/151 (1.99%) 
Diarrhoea * 1  1/155 (0.65%)  2/151 (1.32%) 
Abdominal Pain * 1  0/155 (0.00%)  1/151 (0.66%) 
Cheilitis * 1  0/155 (0.00%)  1/151 (0.66%) 
Duodenitis * 1  0/155 (0.00%)  1/151 (0.66%) 
Enterocolitis * 1  0/155 (0.00%)  1/151 (0.66%) 
Lower Gastrointestinal Haemorrhage * 1  0/155 (0.00%)  1/151 (0.66%) 
Ascites * 1  1/155 (0.65%)  0/151 (0.00%) 
Gastrointestinal Haemorrhage * 1  1/155 (0.65%)  0/151 (0.00%) 
General disorders     
Asthenia * 1  1/155 (0.65%)  2/151 (1.32%) 
Death * 1  1/155 (0.65%)  1/151 (0.66%) 
Fatigue * 1  1/155 (0.65%)  0/151 (0.00%) 
General Physical Health Deterioration * 1  1/155 (0.65%)  0/151 (0.00%) 
Influenza Like Illness * 1  1/155 (0.65%)  0/151 (0.00%) 
Pain * 1  1/155 (0.65%)  0/151 (0.00%) 
Hepatobiliary disorders     
Biliary Obstruction * 1  0/155 (0.00%)  1/151 (0.66%) 
Cholecystitis Acute * 1  0/155 (0.00%)  1/151 (0.66%) 
Jaundice Cholestatic * 1  1/155 (0.65%)  0/151 (0.00%) 
Immune system disorders     
Contrast Media Reaction * 1  0/155 (0.00%)  1/151 (0.66%) 
Infections and infestations     
Pneumonia * 1  4/155 (2.58%)  6/151 (3.97%) 
Covid-19 * 1  1/155 (0.65%)  3/151 (1.99%) 
Cellulitis * 1  1/155 (0.65%)  2/151 (1.32%) 
Rash Pustular * 1  0/155 (0.00%)  2/151 (1.32%) 
Skin Infection * 1  0/155 (0.00%)  2/151 (1.32%) 
Covid-19 Pneumonia * 1  0/155 (0.00%)  1/151 (0.66%) 
Infection * 1  0/155 (0.00%)  1/151 (0.66%) 
Pneumonia Viral * 1  0/155 (0.00%)  1/151 (0.66%) 
Postoperative Wound Infection * 1  1/155 (0.65%)  1/151 (0.66%) 
Sepsis * 1  1/155 (0.65%)  1/151 (0.66%) 
Appendicitis * 1  1/155 (0.65%)  0/151 (0.00%) 
Enterocolitis Infectious * 1  1/155 (0.65%)  0/151 (0.00%) 
Injury, poisoning and procedural complications     
Infusion Related Reaction * 1  0/155 (0.00%)  1/151 (0.66%) 
Lumbar Vertebral Fracture * 1  0/155 (0.00%)  1/151 (0.66%) 
Femur Fracture * 1  1/155 (0.65%)  0/151 (0.00%) 
Incisional Hernia * 1  1/155 (0.65%)  0/151 (0.00%) 
Investigations     
Alanine Aminotransferase Increased * 1  1/155 (0.65%)  1/151 (0.66%) 
Blood Creatinine Increased * 1  1/155 (0.65%)  1/151 (0.66%) 
C-Reactive Protein Increased * 1  0/155 (0.00%)  1/151 (0.66%) 
Aspartate Aminotransferase Increased * 1  1/155 (0.65%)  0/151 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  1/155 (0.65%)  3/151 (1.99%) 
Decreased Appetite * 1  0/155 (0.00%)  1/151 (0.66%) 
Dehydration * 1  0/155 (0.00%)  1/151 (0.66%) 
Hypomagnesaemia * 1  0/155 (0.00%)  1/151 (0.66%) 
Hyponatraemia * 1  1/155 (0.65%)  1/151 (0.66%) 
Hypophagia * 1  1/155 (0.65%)  1/151 (0.66%) 
Hyperglycaemia * 1  1/155 (0.65%)  0/151 (0.00%) 
Malnutrition * 1  1/155 (0.65%)  0/151 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  0/155 (0.00%)  1/151 (0.66%) 
Myalgia * 1  0/155 (0.00%)  1/151 (0.66%) 
Arthralgia * 1  1/155 (0.65%)  0/151 (0.00%) 
Bone Pain * 1  1/155 (0.65%)  0/151 (0.00%) 
Pain in Extremity * 1  1/155 (0.65%)  0/151 (0.00%) 
Pathological Fracture * 1  1/155 (0.65%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate Cancer * 1  0/155 (0.00%)  1/151 (0.66%) 
Cancer Pain * 1  1/155 (0.65%)  0/151 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident * 1  0/155 (0.00%)  1/151 (0.66%) 
Encephalopathy * 1  0/155 (0.00%)  1/151 (0.66%) 
Myoclonic Epilepsy * 1  0/155 (0.00%)  1/151 (0.66%) 
Transient Ischaemic Attack * 1  0/155 (0.00%)  1/151 (0.66%) 
Depressed Level of Consciousness * 1  1/155 (0.65%)  0/151 (0.00%) 
Dysarthria * 1  1/155 (0.65%)  0/151 (0.00%) 
Headache * 1  1/155 (0.65%)  0/151 (0.00%) 
Lacunar Infarction * 1  1/155 (0.65%)  0/151 (0.00%) 
Syncope * 1  1/155 (0.65%)  0/151 (0.00%) 
Vertebrobasilar Insufficiency * 1  1/155 (0.65%)  0/151 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  0/155 (0.00%)  1/151 (0.66%) 
Reproductive system and breast disorders     
Endometrial Thickening * 1  0/155 (0.00%)  1/151 (0.66%) 
Ovarian Mass * 1  0/155 (0.00%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis * 1  0/155 (0.00%)  4/151 (2.65%) 
Pulmonary Embolism * 1  4/155 (2.58%)  4/151 (2.65%) 
Dyspnoea * 1  5/155 (3.23%)  1/151 (0.66%) 
Haemoptysis * 1  1/155 (0.65%)  1/151 (0.66%) 
Pleural Effusion * 1  5/155 (3.23%)  1/151 (0.66%) 
Hypoxia * 1  1/155 (0.65%)  0/151 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis Acneiform * 1  0/155 (0.00%)  2/151 (1.32%) 
Rash * 1  0/155 (0.00%)  2/151 (1.32%) 
Rash Maculo-Papular * 1  0/155 (0.00%)  1/151 (0.66%) 
1
Term from vocabulary, MedDRA Version 25.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm B: Chemotherapy Alone Arm A: Amivantamab + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   149/155 (96.13%)   151/151 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia * 1  70/155 (45.16%)  88/151 (58.28%) 
Anaemia * 1  84/155 (54.19%)  76/151 (50.33%) 
Leukopenia * 1  50/155 (32.26%)  56/151 (37.09%) 
Thrombocytopenia * 1  46/155 (29.68%)  55/151 (36.42%) 
Lymphopenia * 1  11/155 (7.10%)  7/151 (4.64%) 
Eye disorders     
Lacrimation Increased * 1  8/155 (5.16%)  3/151 (1.99%) 
Gastrointestinal disorders     
Constipation * 1  47/155 (30.32%)  60/151 (39.74%) 
Nausea * 1  65/155 (41.94%)  55/151 (36.42%) 
Stomatitis * 1  9/155 (5.81%)  38/151 (25.17%) 
Diarrhoea * 1  19/155 (12.26%)  31/151 (20.53%) 
Vomiting * 1  28/155 (18.06%)  31/151 (20.53%) 
Haemorrhoids * 1  2/155 (1.29%)  18/151 (11.92%) 
Mouth Ulceration * 1  4/155 (2.58%)  12/151 (7.95%) 
Abdominal Pain * 1  4/155 (2.58%)  10/151 (6.62%) 
Gingival Bleeding * 1  2/155 (1.29%)  8/151 (5.30%) 
Abdominal Distension * 1  10/155 (6.45%)  7/151 (4.64%) 
Abdominal Pain Upper * 1  8/155 (5.16%)  4/151 (2.65%) 
General disorders     
Oedema Peripheral * 1  16/155 (10.32%)  45/151 (29.80%) 
Asthenia * 1  28/155 (18.06%)  29/151 (19.21%) 
Pyrexia * 1  9/155 (5.81%)  24/151 (15.89%) 
Fatigue * 1  32/155 (20.65%)  23/151 (15.23%) 
Malaise * 1  12/155 (7.74%)  16/151 (10.60%) 
Mucosal Inflammation * 1  4/155 (2.58%)  15/151 (9.93%) 
Oedema * 1  2/155 (1.29%)  10/151 (6.62%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  6/155 (3.87%)  15/151 (9.93%) 
Infections and infestations     
Paronychia * 1  0/155 (0.00%)  85/151 (56.29%) 
Covid-19 * 1  20/155 (12.90%)  33/151 (21.85%) 
Pneumonia * 1  8/155 (5.16%)  13/151 (8.61%) 
Conjunctivitis * 1  7/155 (4.52%)  9/151 (5.96%) 
Upper Respiratory Tract Infection * 1  6/155 (3.87%)  9/151 (5.96%) 
Urinary Tract Infection * 1  8/155 (5.16%)  6/151 (3.97%) 
Injury, poisoning and procedural complications     
Infusion Related Reaction * 1  2/155 (1.29%)  63/151 (41.72%) 
Investigations     
Alanine Aminotransferase Increased * 1  56/155 (36.13%)  50/151 (33.11%) 
Aspartate Aminotransferase Increased * 1  50/155 (32.26%)  47/151 (31.13%) 
Gamma-Glutamyltransferase Increased * 1  26/155 (16.77%)  21/151 (13.91%) 
Weight Decreased * 1  13/155 (8.39%)  21/151 (13.91%) 
Blood Alkaline Phosphatase Increased * 1  12/155 (7.74%)  19/151 (12.58%) 
Blood Lactate Dehydrogenase Increased * 1  8/155 (5.16%)  13/151 (8.61%) 
Blood Creatinine Increased * 1  14/155 (9.03%)  11/151 (7.28%) 
Metabolism and nutrition disorders     
Hypoalbuminaemia * 1  15/155 (9.68%)  62/151 (41.06%) 
Decreased Appetite * 1  43/155 (27.74%)  54/151 (35.76%) 
Hypokalaemia * 1  13/155 (8.39%)  32/151 (21.19%) 
Hypomagnesaemia * 1  15/155 (9.68%)  22/151 (14.57%) 
Hypocalcaemia * 1  3/155 (1.94%)  19/151 (12.58%) 
Hyponatraemia * 1  12/155 (7.74%)  18/151 (11.92%) 
Hypophosphataemia * 1  2/155 (1.29%)  10/151 (6.62%) 
Hypoproteinaemia * 1  3/155 (1.94%)  10/151 (6.62%) 
Hyperglycaemia * 1  11/155 (7.10%)  8/151 (5.30%) 
Hyperkalaemia * 1  0/155 (0.00%)  8/151 (5.30%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  16/155 (10.32%)  17/151 (11.26%) 
Arthralgia * 1  13/155 (8.39%)  10/151 (6.62%) 
Nervous system disorders     
Dizziness * 1  15/155 (9.68%)  15/151 (9.93%) 
Dysgeusia * 1  10/155 (6.45%)  9/151 (5.96%) 
Headache * 1  13/155 (8.39%)  9/151 (5.96%) 
Psychiatric disorders     
Insomnia * 1  20/155 (12.90%)  16/151 (10.60%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  24/155 (15.48%)  21/151 (13.91%) 
Dyspnoea * 1  20/155 (12.90%)  16/151 (10.60%) 
Pulmonary Embolism * 1  4/155 (2.58%)  11/151 (7.28%) 
Productive Cough * 1  3/155 (1.94%)  9/151 (5.96%) 
Skin and subcutaneous tissue disorders     
Rash * 1  12/155 (7.74%)  81/151 (53.64%) 
Dermatitis Acneiform * 1  5/155 (3.23%)  47/151 (31.13%) 
Dry Skin * 1  6/155 (3.87%)  16/151 (10.60%) 
Alopecia * 1  8/155 (5.16%)  13/151 (8.61%) 
Pruritus * 1  12/155 (7.74%)  10/151 (6.62%) 
Skin Ulcer * 1  1/155 (0.65%)  10/151 (6.62%) 
Erythema * 1  8/155 (5.16%)  1/151 (0.66%) 
Vascular disorders     
Deep Vein Thrombosis * 1  3/155 (1.94%)  10/151 (6.62%) 
Hypertension * 1  10/155 (6.45%)  1/151 (0.66%) 
1
Term from vocabulary, MedDRA Version 25.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director
Organization: Janssen Research & Development
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04538664    
Other Study ID Numbers: CR108850
2020-000633-40 ( EudraCT Number )
61186372NSC3001 ( Other Identifier: Janssen Research & Development, LLC )
2023-506033-29-00 ( Registry Identifier: EUCT number )
First Submitted: August 31, 2020
First Posted: September 4, 2020
Results First Submitted: May 1, 2024
Results First Posted: May 29, 2024
Last Update Posted: June 20, 2024