Lung Cancer Clinical Trial
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Summary
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Full Description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. Lazertinib is an oral, highly potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The study will include screening phase (up to 28 days), a treatment phase (from randomization until the end of treatment visit), and a follow-up phase (from end of treatment visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first). Safety will be assessed by physical examinations, vital signs, electrocardiograms, echocardiograms, ophthalmologic assessments, laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) monitoring, and concomitant medication use. The total duration of the study will be up to 1 year and 11 months.
Eligibility Criteria
Inclusion Criteria:
Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an 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 Started [US]) or an accredited local laboratory (sites outside of the US)
Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)
Exclusion Criteria:
Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
Participant has symptomatic or progressive brain metastases
Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has uncontrolled tumor-related pain
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
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There are 205 Locations for this study
Duarte California, 91010, United States
Irvine California, 92618, United States
La Jolla California, 92093, United States
Long Beach California, 90813, United States
Orange California, 92868, United States
Denver Colorado, 80206, United States
Boca Raton Florida, 33486, United States
Orlando Florida, 32806, United States
Chicago Illinois, 60611, United States
Kansas City Kansas, 66160, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Jackson Mississippi, 39213, United States
East Brunswick New Jersey, 08816, United States
New Brunswick New Jersey, 08901, United States
Bronx New York, 10461, United States
Buffalo New York, 14203, United States
New York New York, 10016, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19104, United States
Charleston South Carolina, 29425, United States
Salt Lake City Utah, 84112, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98104, United States
Buenos Aires , 1431, Argentina
Caba , C1122, Argentina
Ciudad Autonoma de Buenos Aires , C1426, Argentina
Cordoba , 5000, Argentina
Cordoba , 5000, Argentina
Viedma , R8500, Argentina
Adelaide , 5000, Australia
Camperdown , 2050, Australia
Melbourne , 3000, Australia
Murdoch , 6150, Australia
Westmead , 2145, Australia
Woolloongabba , 4102, Australia
Barretos , 14784, Brazil
Belo Horizonte , 30110, Brazil
Curitiba , 80810, Brazil
Florianopolis , 88020, Brazil
Ipatinga , 35162, Brazil
Pelotas , 96020, Brazil
Porto Alegre , 90610, Brazil
Rio de Janeiro , 22061, Brazil
Rio de Janeiro , 22250, Brazil
Rio de Janeiro , 22281, Brazil
Salvador , 40170, Brazil
Santo Andre , 09060, Brazil
São Paulo , 01409, Brazil
São Paulo , 04014, Brazil
São Paulo , 04543, Brazil
São Paulo , 05652, Brazil
Brampton Ontario, L6R 3, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Beijing , 10003, China
Beijing , 10005, China
Beijing , 10014, China
Beijing , 10019, China
Beijing , 10114, China
Beijing , 20024, China
Changchun , 13001, China
Changzhou , 21300, China
Chengdu , 61004, China
Chengdu , 61004, China
Chongqing , 40003, China
ChongQing , 40003, China
Ganzhou , 34100, China
Guang Zhou , 51008, China
Guangzhou , 51012, China
Hang Zhou , 31002, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Harbin , 15008, China
Huizhou , 51600, China
Huizhou , 51600, China
Liuzhou , 54502, China
Nanchong , 63710, China
Shanghai , 20003, China
Shen Zhen Shi , 51800, China
Shenyang , 11000, China
Shenzhen , 51805, China
Tianjin , 30006, China
Wuhan , 43002, China
Xi'an , 71006, China
Xiangyang , 44102, China
Yantai , 26400, China
Zhengzhou , 45000, China
La Tronche , 38700, France
Lille , 59000, France
Limoges , 87000, France
Marseille Cedex 20 , 13915, France
Montpellier , 34090, France
Pessac , 33604, France
Berlin , 13125, Germany
Georgsmarienhütte , 49124, Germany
Giessen , 35392, Germany
Münster , 48149, Germany
Recklinghausen , 45659, Germany
Weinsberg , 74189, Germany
Gurugram , 12200, India
Howrah , 71110, India
Jaipur , 30201, India
Karnad , 56001, India
Kolkata , 70006, India
Mumbai , 40001, India
Nasik , 42200, India
New delhi , 11006, India
New Delhi , 11008, India
Pune , 41104, India
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Petah-Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Bari , 70124, Italy
Bologna , 40138, Italy
Milano , 20141, Italy
Orbassano , 10043, Italy
Padova , 35128, Italy
Ravenna , 48121, Italy
Roma , 00152, Italy
Rome , 00144, Italy
Rozzano , 20089, Italy
Chuo-Ku , 104-0, Japan
Himeji , 670-8, Japan
Hirakata , 573-1, Japan
Kanagawa , 241-8, Japan
Kurashiki , 710-8, Japan
Kurume , 830-0, Japan
Matsusaka , 515-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Sapporo-shi , 060-8, Japan
Shiwa-gun , 028-3, Japan
Shizuoka , 411-8, Japan
Tokyo , 135-8, Japan
Toyoake , 470-1, Japan
Toyonaka-shi , 560-8, Japan
Wakayama , 641-8, Japan
Yamaguchi , 740-8, Japan
Yamaguchi , 755-0, Japan
Gyeonggi-do , 10408, Korea, Republic of
Gyeonggi-do , 13496, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Gyeongsangnam-do , 52727, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Kuala Lumpur , 50450, Malaysia
Kuala Lumpur , 59100, Malaysia
Kuala Lumpur , 59100, Malaysia
Kuching , 93586, Malaysia
Petaling Jaya , 46050, Malaysia
Petaling Jaya , 47500, Malaysia
Bydgoszcz , 85-79, Poland
Krakow , 31-20, Poland
Otwock , 05-40, Poland
Poznan , 60-69, Poland
Warszawa , 02-78, Poland
Braga , 4710-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1998-, Portugal
Senhora da Hora, , 4464-, Portugal
A Coruña , 15006, Spain
Alicante , 03010, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 8028, Spain
Córdoba , 14004, Spain
Las Palmas de Gran Canaria , 35016, Spain
Lugo , 27003, Spain
Madrid , 28009, Spain
Madrid , 28046, Spain
Majadahonda , 28222, Spain
Malaga , 29010, Spain
Oviedo , 33006, Spain
Palma de Mallorca , 07120, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Changhua , 50006, Taiwan
Kaohsiung City , 833, Taiwan
Kaohsiung , 80756, Taiwan
Taichung , 403, Taiwan
Tainan , 70403, Taiwan
Taipei City , 10048, Taiwan
Taipei City , 106, Taiwan
Taoyuan , 33382, Taiwan
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Chiangmai , 50200, Thailand
Adana , 01060, Turkey
Adana , 01120, Turkey
Ankara , 06520, Turkey
Ankara , 06560, Turkey
Ankara , 06590, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Istanbul , 34457, Turkey
Izmir , 35330, Turkey
Izmir , 35575, Turkey
Samsun , 55200, Turkey
Birmingham , B9 5S, United Kingdom
London , W2 1N, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Sutton , SM2 5, United Kingdom
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