Lung Cancer Clinical Trial

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

Summary

The purpose of this study is to assess the anti-tumor activity of amivantamab subcutaneous administered as a Co-Formulation (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) (Cohorts 1, 2, and 3) in combination treatment and to characterize the safety of amivantamab SC-CF (Cohort 4).

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Full Description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. NSCLC accounts for 80 percent (%) to 85% of lung cancers with epidermal growth factor receptor (EGFR) mutations, the Exon 19 deletion (Exon19del) and Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) point mutations. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. The rationale for this study is to collect efficacy, safety, and PK data to support the use of amivantamab SC-CF in regimens and populations currently under study and approved with the IV formulation of amivantamab. The study will include a screening phase (28 days), a treatment phase (21 days [Cohorts 2 and 3] or 28 days [Cohort 1 and 4]), and a follow up phase (after last study treatment until disease progression or death, whichever comes first). Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), echocardiograms, ophthalmologic assessments (Cohorts 1 and 3 and in Cohort 4 [where applicable]), laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] v5.0) monitoring, and concomitant medication use (all cohorts). The total duration of the study is up to 1 year 6 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC). Additional Cohort specific disease requirements include: Cohorts 1 and 3: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation EGFR Exon19del or Exon 21 L858R mutation (Cohort 1 and 3) or EGFR Exon 20 insertion mutation (Cohort 2) 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
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
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
A female 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. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility

Exclusion Criteria:

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
Cohorts 1, 3, and 4 (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. 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. 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).c. uncontrolled (persistent) hypertension: systolic blood pressure >160 millimetre(s) of mercury (mmHg); diastolic blood pressure >100 mmHg. d. 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). e. pericarditis/clinically significant pericardial effusion. f. myocarditis. g. 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

260

Study ID:

NCT05498428

Recruitment Status:

Not yet recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 97 Locations for this study

See Locations Near You

University of California, Irvine
Orange California, 92868, United States
Stanford University
Palo Alto California, 94304, United States
H. Lee Moffitt Cancer & Research Institute
Tampa Florida, 33612, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Hemotology Oncology Associates of CNY
East Syracuse New York, 13057, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond Virginia, 23249, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Fundacao Pio Xii - Hospital De Cancer De Barretos
Barretos , 14784, Brazil
PERSONAL - Oncologia de Precisão e Personalizada
Belo Horizonte , 30130, Brazil
Hospital do Cancer de Londrina
Londrina , 86015, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre , 90035, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro , 22281, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Salvador , 41253, Brazil
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo , 01327, Brazil
Hospital Nove de Julho
São Paulo , 01409, Brazil
Beijing Cancer Hospital of Peking University
Beijing , 10014, China
Jilin cancer hospital
Changchun , 13000, China
Sichuan Cancer Hospital
Chengdu , 61004, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Southwest Hospital
ChongQing , 40003, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou , 51006, China
The First Affiliated Hospital, Zhejiang University College of Medicine
Hangzhou , 31000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou , 31001, China
Harbin medical university cancer hospital
Harbin , 15008, China
Huizhou Municipal Central Hospital
Huizhou , 51600, China
Liuzhou people's Hospital
Liuzhou , 54500, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Tianjin Medical University General Hospital
Tianjin , 30005, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan , 43002, China
Hospital of Jiangnan University
Wuxi , 21412, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71006, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Centre Francois Baclesse
Caen Cedex 05 , 14076, France
Centre Georges-François Leclerc
Dijon , 21079, France
Centre Leon Bérard
Lyon Cedex 8 , 69373, France
Institut Curie
PARIS Cedex 5 , 75248, France
Institut de cancerologie de l'ouest
Saint-Herblain Cedex , 44805, France
Gustave Roussy
Villejuif Cedex , 94800, France
Evangelische Lungenklinik Berlin
Berlin , 13125, Germany
LungenClinic Grosshansdorf GmbH
Grosshandorf , 22927, Germany
Lungenfachklinik Immenhausen
Immenhausen , 34376, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Wuerzburg , 97074, Germany
Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital
Haifa , 31096, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center
Petah Tikva , 49414, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Policlinico Hospital San Martino- IRCCS for Oncology
Genova , 16132, Italy
Ospedale San Raffaele
Milano , 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Azienda Ospedaliera San Gerardo
Monza , 20090, Italy
Azienda Ospedaliera Specialistica dei Colli
Naples , 80131, Italy
National Hospital Organization Himeji Medical Center
Himeji , 670-8, Japan
Matsusaka Municipal Hospital
Matsusaka , 515-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
National Cancer Center
Goyang-Si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan , 25100, Malaysia
Hospital Umum Sarawak
Kuching , 93586, Malaysia
Beacon Hospital Sdn. Bhd.
Petaling Jaya , 46050, Malaysia
Hosp. Univ. A Coruña
A Coruña , 15006, Spain
General University Hospital of Alicantet
Alacant , 03010, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona , 08025, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Del Mar
Barcelona , 8003, Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona , 8908, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28051, Spain
Hosp. Regional Univ. de Malaga
Malaga , 29010, Spain
Hosp. Virgen Macarena
Sevilla , 41009, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Hosp. Gral. Univ. Valencia
Valencia , 46014, Spain
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
Torbay Hospital-Devon
Devon , TQ2 7, United Kingdom
Edinburgh Cancer Centre Western General
Edinburgh , EH4 2, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
University College London Hospitals
London , NW1 2, United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
Southampton University Hospital
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

260

Study ID:

NCT05498428

Recruitment Status:

Not yet recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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