Actively Recruiting
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
520
Participants Needed
110
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
CONDITIONS
Official Title
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
- All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
- May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
- Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
- Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
- A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility
You will not qualify if you...
- Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
- Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
- Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary
- For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
- Other clinically active liver disease of infectious origin
- Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan
- Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or equivalent) for at least 2 weeks prior to treatment allocation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 110 locations
1
University of California at San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
3
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
4
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
5
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
Completed
6
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
7
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
8
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States, 33612
Completed
9
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
10
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland, United States, 21224
Actively Recruiting
11
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
12
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
14
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
15
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States, 13057
Completed
16
Novant Health 1
Charlotte, North Carolina, United States, 28204
Completed
17
Novant Health
Winston-Salem, North Carolina, United States, 27106
Completed
18
Cleveland Clinic 1
Cleveland, Ohio, United States, 44111
Completed
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Completed
20
Cleveland Clinic 2
Mayfield Heights, Ohio, United States, 44124
Completed
21
Cleveland Clinic 3
Warrensville Heights, Ohio, United States, 44122
Completed
22
The Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Completed
23
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
24
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Completed
25
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Completed
26
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
27
Fundacao Pio XII
Barretos, Brazil, 14784-400
Actively Recruiting
28
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, Brazil, 30130 090
Actively Recruiting
29
Instituto do Cancer de Londrina Hospital do Cancer de Londrina
Londrina, Brazil, 86015
Actively Recruiting
30
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90035-001
Actively Recruiting
31
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, Brazil, 22281 100
Actively Recruiting
32
Instituto D Or de Pesquisa e Ensino IDOR 1
Salvador, Brazil, 41253-190
Actively Recruiting
33
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil, 01327 001
Actively Recruiting
34
Impar Servicos Hospitalares SA Hospital Nove de Julho
São Paulo, Brazil, 01409-001
Completed
35
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil, 01509 900
Actively Recruiting
36
Affiliated Hospital of Hebei University
Baoding, China, 071051
Completed
37
Jilin cancer hospital
Changchun, China, 130000
Actively Recruiting
38
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
39
West China Hospital Sichuan University
Chengdu, China, 610047
Actively Recruiting
40
The First Affiliated Hospital of PLA Army Medical University
Chongqing, China, 400038
Actively Recruiting
41
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China, 510060
Actively Recruiting
42
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, China, 310003
Actively Recruiting
43
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China, 310016
Actively Recruiting
44
Harbin medical university cancer hospital
Harbin, China, 150000
Actively Recruiting
45
Huizhou Municipal Central Hospital
Huizhou, China, 516001
Actively Recruiting
46
Liuzhou people's Hospital
Liuzhou, China, 545006
Completed
47
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
48
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
49
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
50
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
51
Hospital of Jiangnan University
Wuxi, China, 214122
Completed
52
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China, 710061
Actively Recruiting
53
Yantai Yuhuangding Hospital
Yantai, China, 264000
Completed
54
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
55
Centre Georges-François Leclerc
Dijon, France, 21079
Completed
56
Institut de Cancérologie du Gard
Nîmes, France, 30029
Actively Recruiting
57
Institut Curie
Paris, France, 75248
Actively Recruiting
58
Institut de cancerologie de l'ouest
Saint-Herblain, France, 44805
Actively Recruiting
59
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
60
Evangelische Lungenklinik Berlin
Berlin, Germany, 13125
Completed
61
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
62
LungenClinic Grosshansdorf GmbH
Grosshandorf, Germany, 22927
Actively Recruiting
63
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Actively Recruiting
64
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, Germany, 97074
Actively Recruiting
65
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
66
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
67
Meir Medical Center
Kfar Saba, Israel, 44281
Completed
68
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
69
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
70
Policlinico Hospital San Martino- IRCCS for Oncology
Genova, Italy, 16132
Actively Recruiting
71
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
72
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
73
Azienda Ospedaliera San Gerardo
Monza, Italy, 20090
Actively Recruiting
74
Azienda Ospedaliera Specialistica dei Colli
Naples, Italy, 80131
Actively Recruiting
75
National Hospital Organization Himeji Medical Center
Himeji, Japan, 670-8520
Active, Not Recruiting
76
Saiseikai Matsusaka Municipal Hospital
Matsusaka, Japan, 515 8544
Active, Not Recruiting
77
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Active, Not Recruiting
78
Shizuoka Cancer Center
Shizuoka, Japan, 411 8777
Active, Not Recruiting
79
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135 8550
Active, Not Recruiting
80
Wakayama Medical University Hospital
Wakayama, Japan, 641 8510
Active, Not Recruiting
81
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
82
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia, 25100
Actively Recruiting
83
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
84
Beacon Hospital Sdn Bhd
Petaling Jaya, Malaysia, 46050
Actively Recruiting
85
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
86
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
87
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
88
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
89
Asan Medical Center
Seoul, South Korea, 05505
Completed
90
Hosp Univ A Coruna
A Coruña, Spain, 15006
Actively Recruiting
91
General University Hospital of Alicantet
Alicante, Spain, 03010
Actively Recruiting
92
Hosp. Del Mar
Barcelona, Spain, 08003
Actively Recruiting
93
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
94
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
95
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, Spain, 8908
Actively Recruiting
96
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
97
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
98
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
99
Hosp. Univ. La Paz
Madrid, Spain, 28046
Actively Recruiting
100
Hosp Regional Univ de Malaga
Málaga, Spain, 29010
Actively Recruiting
101
Hosp. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
102
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Actively Recruiting
103
Hosp. Gral. Univ. Valencia
Valencia, Spain, 46014
Actively Recruiting
104
Cheltenham General Hospital
Cheltenham, United Kingdom, GL53 7AN
Completed
105
Torbay Hospital-Devon
Devon, United Kingdom, TQ2 7AA
Actively Recruiting
106
Edinburgh Cancer Centre Western General
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
107
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
108
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
109
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
110
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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