Phase
Condition
N/ATreatment
Pemetrexed
Direct Oral Anticoagulant (DOAC)
Amivantamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have histologically or cytologically confirmed, locally advanced ormetastatic, non-small cell lung cancer (NSCLC) that is not amenable to curativetherapy including surgical resection or chemoradiation. Additional Cohort specificdisease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factorreceptor (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 anyprior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2:Participant should not have received any prior systemic therapy for locally advancedor metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or afterosimertinib monotherapy as the most recent line of treatment. Osimertinib must havebeen administered as either the first-line treatment for locally advanced ormetastatic 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, anexpanded access program, or as a rollover from a long-term extension, without anyamivantamab dose reduction. Cohort 7: Participants must have progressed on or afterthe combination of amivantamab and lazertinib as the most recent line of treatment.The combination of amivantamab and lazertinib must have been administered as thefirst-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 asdetermined by Food and Drug Administration (FDA) approved or other validated test ofeither circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinicallaboratory improvement amendments (CLIA) certified laboratory (sites in the Unitedstates [US]) or an accredited local laboratory (sites outside of the US). A copy ofthe initial test report documenting the EGFR mutation must be included in theparticipant 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. Ifthe only target lesion has been previously irradiated, it must show signs of diseaseprogression since radiation was completed If only 1 non-irradiated measurable lesionexists, which undergoes a biopsy and is acceptable as a target lesion, the baselinetumor assessment scans should be performed at least 14 days after the biopsy
May have a prior or concurrent second malignancy (other than the disease understudy) which natural history or treatment is unlikely to interfere with any studyendpoints 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 prophylacticanticoagulation with a direct oral anticoagulant or a low molecular weight heparinduring the first 4 months of study treatment
A participant must agree not to donate eggs (ova, oocytes) or freeze for future usefor the purposes of assisted reproduction during the study and for a period of 6months after receiving the last dose of study treatment. Female participants shouldconsider preservation of eggs prior to study treatment as anti-cancer treatments mayimpair fertility
Exclusion
Exclusion Criteria:
Participant has a medical history of interstitial lung disease (ILD), including druginduced ILD or radiation pneumonitis
Participant has a history of hypersensitivity to any excipients of theinvestigational products to be used in their enrollment cohort
Participant has received a live or live attenuated vaccine within 3 months beforeCycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines againstCoronavirus disease 19 (COVID-19) are not exclusionary
For all cohorts (with regimens potentially including lazertinib): Participant iscurrently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout periodprior to Cycle 1 Day 1
Other clinically active liver disease of infectious origin
Participant has a history of clinically significant cardiovascular diseaseincluding, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis orpulmonary embolism within 1 month prior to the first dose of study treatment(s), orany 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. Clinicallynon-significant thrombosis, such as non-obstructive catheter-associated clots, arenot 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 includinglazertinib): Participant has a prior history of VTE and is not on appropriatetherapeutic anticoagulation as per NCCN or local guidelines; d) prolonged correctedQT 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 withuncontrolled rate); e) uncontrolled (persistent) hypertension: systolic bloodpressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg;f) Congestive heart failure defined as NYHA class III-IV or hospitalization forcongestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinicallysignificant pericardial effusion; h) myocarditis; i) baseline left ventricularejection 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 orpreviously treated and stable brain metastases may participate in this study.Participants who have received definitive radiation or surgical treatment forsymptomatic or unstable brain metastases and have been clinically stable andasymptomatic for at least 2 weeks before Screening are eligible, provided they havebeen either off corticosteroid treatment or are receiving low-dose corticosteroidtreatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone orequivalent) for at least 2 weeks prior to treatment allocation
Study Design
Connect with a study center
Austin Hospital
Heidelberg, VIC 3084
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands, 6009
AustraliaSite Not Available
Fundacao Pio XII
Barretos, 14784-400
BrazilActive - Recruiting
PERSONAL - Oncologia de Precisão e Personalizada
Belo Horizonte, 30130 090
BrazilActive - Recruiting
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, 30130 090
BrazilActive - Recruiting
Instituto do Cancer de Londrina - Hospital do Cancer de Londrina
Londrina, 86015
BrazilActive - Recruiting
Instituto do Cancer de Londrina Hospital do Cancer de Londrina
Londrina, 86015
BrazilActive - Recruiting
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
BrazilActive - Recruiting
Associação Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
BrazilActive - Recruiting
Instituto D Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro, 22281 100
BrazilActive - Recruiting
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, 22281 100
BrazilActive - Recruiting
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro, 22281-100
BrazilActive - Recruiting
Instituto D Or de Pesquisa e Ensino (IDOR)
Salvador, 41253-190
BrazilActive - Recruiting
Instituto D Or de Pesquisa e Ensino IDOR
Salvador, 41253-190
BrazilActive - Recruiting
Instituto D'Or de Pesquisa e Ensino (IDOR)
Salvador, 41253-190
BrazilActive - Recruiting
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
Sao Paulo, 01509900
BrazilActive - Recruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
Sao Paulo, 01509 900
BrazilActive - Recruiting
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo, 01509900
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
Sao Paulo, 01327 001
BrazilActive - Recruiting
Impar Servicos Hospitalares SA - Hospital Nove de Julho
Sao Paulo, 01409-001
BrazilActive - Recruiting
Impar Servicos Hospitalares SA Hospital Nove de Julho
Sao Paulo, 01409-001
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001
BrazilSite Not Available
Hospital Alemão Oswaldo Cruz
São Paulo, 01327-001
BrazilActive - Recruiting
Affiliated Hospital of Hebei University
Bao Ding Shi, 071051
ChinaActive - Recruiting
Affiliated Hospital of Hebei University
Baoding, 71000
ChinaSite Not Available
Beijing Cancer Hospital of Peking University
Beijing, 100142
ChinaSite Not Available
Jilin cancer hospital
Changchun, 130000
ChinaActive - Recruiting
Sichuan Cancer Hospital
Chengdu, 610041
ChinaActive - Recruiting
West China Hospital Sichuan University
Chengdu, 610047
ChinaActive - Recruiting
West China Hospital, Sichuan University
Chengdu, 610047
ChinaActive - Recruiting
Southwest Hospital
ChongQing, 400038
ChinaActive - Recruiting
The First Affiliated Hospital of PLA Army Medical University
ChongQing, 400038
ChinaActive - Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510060
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510060
ChinaActive - Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310016
ChinaActive - Recruiting
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University College of Medicine
Hangzhou, 310003
ChinaActive - Recruiting
Harbin medical university cancer hospital
Harbin, 150000
ChinaActive - Recruiting
Huizhou Municipal Central Hospital
Huizhou, 516001
ChinaActive - Recruiting
Liuzhou people's Hospital
Liuzhou, 545006
ChinaCompleted
Fudan University Shanghai Cancer Center
Shanghai, 200032
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
ChinaActive - Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
ChinaActive - Recruiting
Hospital of Jiangnan University
Wuxi, 214122
ChinaCompleted
The First Affiliated Hospital of Xi'an Jiaotong University
XI An, 710061
ChinaActive - Recruiting
The First Affiliated Hospital of Xian Jiaotong University
XI An, 710061
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai, 264000
ChinaCompleted
Centre Francois Baclesse
Caen Cedex 05, 14076
FranceActive - Recruiting
Centre Georges-François Leclerc
Dijon, 21079
FranceCompleted
Centre Leon Bérard
Lyon Cedex 8, 69373
FranceSite Not Available
Institut de Cancérologie du Gard
Nîmes, 30029
FranceActive - Recruiting
Institut Curie
PARIS Cedex 5, 75248
FranceActive - Recruiting
Institut de cancerologie de l'ouest
Saint-Herblain Cedex, 44805
FranceActive - Recruiting
Gustave Roussy
Villejuif Cedex, 94800
FranceActive - Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125
GermanyCompleted
LungenClinic Grosshansdorf GmbH
Grosshandorf, 22927
GermanyActive - Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376
GermanyActive - Recruiting
Universitaetsklinikum Koeln
Koeln, 50937
GermanyActive - Recruiting
Universitaetsklinikum Koelnt
Koeln, 50937
GermanyActive - Recruiting
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Wuerzburg, 97074
GermanyActive - Recruiting
Rambam Medical Center
Haifa, 3109601
IsraelActive - Recruiting
Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital
Haifa, 3109601
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Meir Medical Center
Kfar Saba, 44281
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 4941492
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 52621
IsraelActive - Recruiting
Policlinico Hospital San Martino- IRCCS for Oncology
Genova, 16132
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalyActive - Recruiting
Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Azienda Ospedaliera San Gerardo
Monza, 20090
ItalyActive - Recruiting
Azienda Ospedaliera Specialistica dei Colli
Naples, 80131
ItalyActive - Recruiting
National Hospital Organization Himeji Medical Center
Himeji, 670-8520
JapanSite Not Available
Matsusaka Municipal Hospital
Matsusaka, 515-8544
JapanSite Not Available
Niigata Cancer Center Hospital
Niigata, 951-8566
JapanSite Not Available
Shizuoka Cancer Center
Shizuoka, 411 8777
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
JapanSite Not Available
Wakayama Medical University Hospital
Wakayama, 641 8510
JapanSite Not Available
National Cancer Center
Goyang-Si, 10408
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, 25100
MalaysiaActive - Recruiting
Hospital Umum Sarawak
Kuching, 93586
MalaysiaActive - Recruiting
Beacon Hospital Sdn Bhd
Petaling Jaya, 46050
MalaysiaActive - Recruiting
Beacon Hospital Sdn. Bhd.
Petaling Jaya, 46050
MalaysiaActive - Recruiting
Hosp Univ A Coruna
A Coruña, 15006
SpainActive - Recruiting
Hosp. Univ. A Coruna
A Coruña, 15006
SpainSite Not Available
Hosp. Univ. A Coruña
A Coruña, 15006
SpainActive - Recruiting
General University Hospital of Alicantet
Alacant, 03010
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. Del Mar
Barcelona, 08003
SpainActive - Recruiting
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 8908
SpainActive - Recruiting
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hosp. Univ. 12 De Octubre
Madrid, 28051
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp. Univ. La Paz
Madrid, 28046
SpainActive - Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainActive - Recruiting
Hosp Regional Univ de Malaga
Malaga, 29010
SpainActive - Recruiting
Hosp. Regional Univ. de Malaga
Malaga, 29010
SpainSite Not Available
Hosp. Virgen Macarena
Sevilla, 41009
SpainActive - Recruiting
Hosp. Clinico Univ. De Valencia
Valencia, 46010
SpainActive - Recruiting
Hosp. Clinico Univ. de Valencia
Valencia, 46010
SpainActive - Recruiting
Hosp. Gral. Univ. Valencia
Valencia, 46014
SpainActive - Recruiting
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
United KingdomSite Not Available
Cheltenham General Hospital
Cheltenham, GL53 7AN
United KingdomCompleted
Torbay Hospital-Devon
Devon, TQ2 7AA
United KingdomActive - Recruiting
Edinburgh Cancer Centre Western General
Edinburgh, EH4 2XU
United KingdomActive - Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
United KingdomActive - Recruiting
Sarah Cannon Research Institute
London, W1G 6AD
United KingdomSite Not Available
University College London Hospitals
London, NW1 2PG
United KingdomActive - Recruiting
Nottingham City Hospital
Nottingham, NG5 1PB
United KingdomActive - Recruiting
GenesisCare Oxford
Oxford, OX4 6LB
United KingdomSite Not Available
Queen Alexandra Hospital
Portsmouth, PO6 3LY
United KingdomActive - Recruiting
Southampton University Hospital
Southampton, SO16 6YD
United KingdomSite Not Available
University of California at San Diego
La Jolla, California 92093
United StatesActive - Recruiting
University of California Irvine
Orange, California 92868
United StatesActive - Recruiting
University of California, Irvine
Orange, California 92868
United StatesActive - Recruiting
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Stanford Cancer Institute
Stanford, California 94305
United StatesActive - Recruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington, District of Columbia 20016
United StatesActive - Recruiting
Baptist Lynn Cancer Institute
Boca Raton, Florida 33486
United StatesCompleted
Mount Sinai Medical Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
AdventHealth
Orlando, Florida 32804
United StatesActive - Recruiting
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida 33612
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland 21224
United StatesActive - Recruiting
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
Hematology-Oncology Associates of CNY
East Syracuse, New York 13057
United StatesCompleted
Hemotology Oncology Associates of CNY
East Syracuse, New York 13057
United StatesCompleted
Novant Health
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Novant Health
Winston-Salem, North Carolina 27106
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44111
United StatesCompleted
Cleveland Clinic
Mayfield Heights, Ohio 44124
United StatesCompleted
Cleveland Clinic
Warrensville Heights, Ohio 44122
United StatesCompleted
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
The Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesCompleted
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesActive - Recruiting
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia 23249
United StatesSite Not Available
Providence Regional Cancer Partnership
Everett, Washington 98201
United StatesCompleted
Swedish Cancer Institute
Seattle, Washington 98104
United StatesActive - Recruiting
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesCompleted
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