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).
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.
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
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There are 97 Locations for this study
Orange California, 92868, United States
Palo Alto California, 94304, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21287, United States
New Brunswick New Jersey, 08901, United States
Bronx New York, 10461, United States
East Syracuse New York, 13057, United States
Cleveland Ohio, 44195, United States
Salt Lake City Utah, 84112, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23249, United States
Seattle Washington, 98104, United States
Barretos , 14784, Brazil
Belo Horizonte , 30130, Brazil
Londrina , 86015, Brazil
Porto Alegre , 90035, Brazil
Rio de Janeiro , 22281, Brazil
Salvador , 41253, Brazil
Sao Paulo , 01509, Brazil
São Paulo , 01327, Brazil
São Paulo , 01409, Brazil
Beijing , 10014, China
Changchun , 13000, China
Chengdu , 61004, China
Chengdu , 61004, China
ChongQing , 40003, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Harbin , 15008, China
Huizhou , 51600, China
Liuzhou , 54500, China
Shanghai , 20003, China
Tianjin , 30005, China
Wenzhou , 32500, China
Wuhan , 43002, China
Wuxi , 21412, China
Xi'an , 71006, China
Yantai , 26400, China
Caen Cedex 05 , 14076, France
Dijon , 21079, France
Lyon Cedex 8 , 69373, France
PARIS Cedex 5 , 75248, France
Saint-Herblain Cedex , 44805, France
Villejuif Cedex , 94800, France
Berlin , 13125, Germany
Grosshandorf , 22927, Germany
Immenhausen , 34376, Germany
Koeln , 50937, Germany
Wuerzburg , 97074, Germany
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Genova , 16132, Italy
Milano , 20132, Italy
Milano , 20162, Italy
Monza , 20090, Italy
Naples , 80131, Italy
Himeji , 670-8, Japan
Matsusaka , 515-8, Japan
Niigata , 951-8, Japan
Shizuoka , 411-8, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
Goyang-Si , 10408, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Kuala Lumpur , 59100, Malaysia
Kuantan , 25100, Malaysia
Kuching , 93586, Malaysia
Petaling Jaya , 46050, Malaysia
A Coruña , 15006, Spain
Alacant , 03010, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Barcelona , 8003, Spain
Barcelona , 8908, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Madrid , 28051, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Valencia , 46014, Spain
Bristol , BS2 8, United Kingdom
Devon , TQ2 7, United Kingdom
Edinburgh , EH4 2, United Kingdom
Leicester , LE1 5, United Kingdom
London , NW1 2, United Kingdom
London , W1G 6, United Kingdom
Southampton , SO16 , United Kingdom
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