{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T08:19:18Z","timestamp":1791533958312,"version":"4.3.4"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"30","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,10,20]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>\n              Phase III studies of intravenous amivantamab demonstrated efficacy across epidermal growth factor receptor (\n              <jats:italic>EGFR<\/jats:italic>\n              )\u2013mutated advanced non\u2013small cell lung cancer (NSCLC). A subcutaneous formulation could improve tolerability and reduce administration time while maintaining efficacy.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>PATIENTS AND METHODS<\/jats:title>\n            <jats:p>\n              Patients with\n              <jats:italic>EGFR<\/jats:italic>\n              -mutated advanced NSCLC who progressed after osimertinib and platinum-based chemotherapy were randomly assigned 1:1 to receive subcutaneous or intravenous amivantamab, both combined with lazertinib. Coprimary pharmacokinetic noninferiority end points were trough concentrations (C\n              <jats:sub>trough<\/jats:sub>\n              ; on cycle-2-day-1 or cycle-4-day-1) and cycle-2 area under the curve (AUC\n              <jats:sub>D1-D15<\/jats:sub>\n              ). Key secondary end points were objective response rate (ORR) and progression-free survival (PFS). Overall survival (OS) was a predefined exploratory end point.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              Overall, 418 patients underwent random assignment (subcutaneous group, n = 206; intravenous group, n = 212). Geometric mean ratios of C\n              <jats:sub>trough<\/jats:sub>\n              for subcutaneous to intravenous amivantamab were 1.15 (90% CI, 1.04 to 1.26) at cycle-2-day-1 and 1.42 (90% CI, 1.27 to 1.61) at cycle-4-day-1; the cycle-2 AUC\n              <jats:sub>D1-D15<\/jats:sub>\n              was 1.03 (90% CI, 0.98 to 1.09). ORR was 30% in the subcutaneous and 33% in the intravenous group; median PFS was 6.1 and 4.3 months, respectively. OS was significantly longer in the subcutaneous versus intravenous group (hazard ratio for death, 0.62; 95% CI, 0.42 to 0.92; nominal\n              <jats:italic>P<\/jats:italic>\n              = .02). Fewer patients in the subcutaneous group experienced infusion-related reactions (IRRs; 13%\n              <jats:italic>v<\/jats:italic>\n              66%) and venous thromboembolism (9%\n              <jats:italic>v<\/jats:italic>\n              14%) versus the intravenous group. Median administration time for the first infusion was reduced to 4.8 minutes (range, 0-18) for subcutaneous amivantamab and to 5 hours (range, 0.2-9.9) for intravenous amivantamab. During cycle-1-day-1, 85% and 52% of patients in the subcutaneous and intravenous groups, respectively, considered treatment convenient; the end-of-treatment rates were 85% and 35%, respectively.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Subcutaneous amivantamab-lazertinib demonstrated noninferiority to intravenous amivantamab-lazertinib, offering a consistent safety profile with reduced IRRs, increased convenience, and prolonged survival.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco.24.01001","type":"journal-article","created":{"date-parts":[[2024,6,10]],"date-time":"2024-06-10T19:59:13Z","timestamp":1718049553000},"page":"3593-3605","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":132,"title":["Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor\u2013Mutated Non\u2013Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct05388669","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3249-4602","authenticated-orcid":false,"given":"Natasha B.","family":"Leighl","sequence":"first","affiliation":[{"name":"Princess Margaret Cancer Centre, Toronto, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5856-5512","authenticated-orcid":false,"given":"Hiroaki","family":"Akamatsu","sequence":"additional","affiliation":[{"name":"Internal Medicine III, Wakayama Medical University, Wakayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7694-1593","authenticated-orcid":false,"given":"Sun Min","family":"Lim","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9908-597X","authenticated-orcid":false,"given":"Ying","family":"Cheng","sequence":"additional","affiliation":[{"name":"Jilin Cancer Hospital, Changchun, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9339-7101","authenticated-orcid":false,"given":"Anna R.","family":"Minchom","sequence":"additional","affiliation":[{"name":"Drug Development Unit, The Royal Marsden Hospital and The Institute of Cancer Research, Sutton, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2187-3583","authenticated-orcid":false,"given":"Melina E.","family":"Marmarelis","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0542-6054","authenticated-orcid":false,"given":"Rachel E.","family":"Sanborn","sequence":"additional","affiliation":[{"name":"Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5586-5138","authenticated-orcid":false,"given":"James","family":"Chih-Hsin Yang","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baogang","family":"Liu","sequence":"additional","affiliation":[{"name":"Harbin Medical University Cancer Hospital, Harbin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3399-5342","authenticated-orcid":false,"given":"Thomas","family":"John","sequence":"additional","affiliation":[{"name":"Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7608-3952","authenticated-orcid":false,"given":"Bartomeu","family":"Massut\u00ed","sequence":"additional","affiliation":[{"name":"Alicante University Dr. Balmis Hospital, ISABIAL, Alicante, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1303-0447","authenticated-orcid":false,"given":"Alexander I.","family":"Spira","sequence":"additional","affiliation":[{"name":"Virginia Cancer Specialists, Fairfax, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9219-3350","authenticated-orcid":false,"given":"Se-Hoon","family":"Lee","sequence":"additional","affiliation":[{"name":"Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jialei","family":"Wang","sequence":"additional","affiliation":[{"name":"Fudan University Shanghai Cancer Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1617-3294","authenticated-orcid":false,"given":"Juan","family":"Li","sequence":"additional","affiliation":[{"name":"Sichuan Cancer Hospital, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caigang","family":"Liu","sequence":"additional","affiliation":[{"name":"Shengjing Hospital of China Medical University, Shenyang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7653-9748","authenticated-orcid":false,"given":"Silvia","family":"Novello","sequence":"additional","affiliation":[{"name":"Department of Oncology, University of Turin, S. Luigi Gonzaga Hospital, Orbassano (TO), Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Kondo","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohiro","family":"Tamiya","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto","family":"Korbenfeld","sequence":"additional","affiliation":[{"name":"British Hospital of Buenos Aires\u2014Central British Hospital, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mor","family":"Moskovitz","sequence":"additional","affiliation":[{"name":"Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5033-0006","authenticated-orcid":false,"given":"Ji-Youn","family":"Han","sequence":"additional","affiliation":[{"name":"National Cancer Center, Goyang, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariam","family":"Alexander","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina, Charleston, SC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4607-3937","authenticated-orcid":false,"given":"Rohit","family":"Joshi","sequence":"additional","affiliation":[{"name":"Cancer Research SA, Adelaide, SA, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7620-0098","authenticated-orcid":false,"given":"Enriqueta","family":"Felip","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Vall d\u2019Hebron Barcelona Hospital Campus, Vall d\u2019Hebron Institute of Oncology (VIHO), Universitat Autonoma de Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9638-9860","authenticated-orcid":false,"given":"Pei Jye","family":"Voon","sequence":"additional","affiliation":[{"name":"Department of Radiotherapy and Oncology, Sarawak General Hospital, Kuching, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8230-5232","authenticated-orcid":false,"given":"Pongwut","family":"Danchaivijitr","sequence":"additional","affiliation":[{"name":"Siriraj Hospital, Faculty of Medicine, Mahidol University Bangkok Noi Campus, Bangkok, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0173-7509","authenticated-orcid":false,"given":"Ping-Chih","family":"Hsu","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4558-4850","authenticated-orcid":false,"given":"Felipe Jos\u00e9","family":"Silva Melo Cruz","sequence":"additional","affiliation":[{"name":"N\u00facleo de Ensino e Pequisa, Instituto Brasileiro de Controle do C\u00e2ncer, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Wehler","sequence":"additional","affiliation":[{"name":"University Hospital of Giessen and Marburg, Giessen and Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5807-9503","authenticated-orcid":false,"given":"Laurent","family":"Greillier","sequence":"additional","affiliation":[{"name":"Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, APHM, INSERM, CNRS, CRCM, H\u00f4pital Nord, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Encarna\u00e7\u00e3o","family":"Teixeira","sequence":"additional","affiliation":[{"name":"Medical Oncology, Hospital CUF Descobertas, Lisboa, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2479-2271","authenticated-orcid":false,"given":"Danny","family":"Nguyen","sequence":"additional","affiliation":[{"name":"City of Hope National Medical Center, Duarte, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1556-1543","authenticated-orcid":false,"given":"Joshua K.","family":"Sabari","sequence":"additional","affiliation":[{"name":"Perlmutter Cancer Center, New York University Langone Health, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0339-3087","authenticated-orcid":false,"given":"Angel","family":"Qin","sequence":"additional","affiliation":[{"name":"University of Michigan Rogel Cancer Center, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9452-3229","authenticated-orcid":false,"given":"Dariusz","family":"Kowalski","sequence":"additional","affiliation":[{"name":"Department of Lung Cancer and Thoracic Tumors, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7021-6139","authenticated-orcid":false,"given":"Mehmet Ali Nahit","family":"\u015eendur","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Ankara Y\u0131ld\u0131r\u0131m Beyaz\u0131t University, Ankara City Hospital, Ankara, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Xie","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Raritan, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debopriya","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Raritan, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4008-7011","authenticated-orcid":false,"given":"Ali","family":"Alhadab","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3071-8255","authenticated-orcid":false,"given":"Nahor","family":"Haddish-Berhane","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Spring House, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5562-9824","authenticated-orcid":false,"given":"Pamela L.","family":"Clemens","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Spring House, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Lorenzini","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Spring House, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Remy B.","family":"Verheijen","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Leiden, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Gamil","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Spring House, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4193-841X","authenticated-orcid":false,"given":"Joshua M.","family":"Bauml","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Spring House, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahadi","family":"Baig","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, Raritan, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7575-3870","authenticated-orcid":false,"given":"Antonio","family":"Passaro","sequence":"additional","affiliation":[{"name":"European Institute of Oncology IRCCS, Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the PALOMA-3 Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Akamatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariam","family":"Alexander","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalen","family":"Bleckmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Cappuzzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byoung Chul","family":"Cho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timucin","family":"Cil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis","family":"Cortot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pongwut","family":"Danchaivijitr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Till-Oliver","family":"Emde","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dilek","family":"Erdem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enriqueta","family":"Felip","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernanda","family":"Estevinho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Lurdes Ferreira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavio Ferreira","family":"da Silva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria del Rosario","family":"Garcia Campelo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Greillier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alastair","family":"Greystoke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji-Youn","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping-Chih","family":"Hsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jen-Yu","family":"Hung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mei","family":"Ji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"John","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit","family":"Joshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young-Chul","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Kondo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto","family":"Korbenfeld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dariusz","family":"Kowalski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Se-Hoon","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Leighl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng-Hao","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baogang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caigang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Seng-Hooi Low","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melina E.","family":"Marmarelis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bartomeu","family":"Massut\u00ed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna R.","family":"Minchom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Moore","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mor","family":"Moskovitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adnan","family":"Nagrial","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danny","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Novello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mustafa","family":"\u00d6zg\u00fcro\u011flu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozgur","family":"Ozyilkan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Passaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nir","family":"Peled","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naiyarat","family":"Prasongsook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angel","family":"Qin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa F.","family":"Ramos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua K.","family":"Sabari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Salinas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel E.","family":"Sanborn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehmet Ali Nahit","family":"Sendur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe","family":"Jos\u00e9 Silva Melo Cruz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander I.","family":"Spira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thatthan","family":"Suksombooncharoen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohiro","family":"Tamiya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiunn","family":"Liang Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Encarnacao","family":"Teixeira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajanikar","family":"Tota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damien","family":"Urban","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Vergnen\u00e8gre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pei Jye","family":"Voon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanina","family":"Wainsztein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jialei","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Wehler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Chih-Hsin Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshige","family":"Yoshioka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alona","family":"Zer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanqiu","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bogdan","family":"Zurawski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_10_2_2","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-15-2833"},{"key":"e_1_3_10_3_2","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-20-0071"},{"key":"e_1_3_10_4_2","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-20-0116"},{"key":"e_1_3_10_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cllc.2022.11.004"},{"key":"e_1_3_10_6_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2023.41.16_suppl.9013"},{"key":"e_1_3_10_7_2","volume-title":"RYBREVANT (Amivantamab-vmjw) Injection, for Intravenous Use [prescribing Information]","year":"2024","unstructured":"RYBREVANT (Amivantamab-vmjw) Injection, for Intravenous Use [prescribing Information]. Horsham, PA: Janssen Biotech, 2024"},{"key":"e_1_3_10_8_2","article-title":"Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC","author":"Cho BC","unstructured":"Cho BC, Lu S, Felip E, et al: Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med 10.1056\/NEJMoa2403614 [epub ahead of print June 26, 2024]","journal-title":"N Engl J Med"},{"key":"e_1_3_10_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2023.02.008"},{"key":"e_1_3_10_10_2","doi-asserted-by":"crossref","unstructured":"Minchom A Krebs MG Cho BC et al: Subcutaneous amivantamab in patients with advanced solid malignancies: The PALOMA study\u2014updated safety and confirmation of the recommended phase 2 dose. Presented at American Society of Clinical Oncology (ASCO) Annual Meeting Chicago IL June 2-6 2023","DOI":"10.1200\/JCO.2023.41.16_suppl.9126"},{"key":"e_1_3_10_11_2","unstructured":"Leighl N Cho BC Hiret S et al: Amivantamab in patients with advanced NSCLC and MET exon14 skipping mutation: Results from the CHRYSALIS study. Presented at IASLC 2023 World Conference on Lung Cancer Singapore September 9-12 2023"},{"key":"e_1_3_10_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.11.012"},{"key":"e_1_3_10_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.10.117"},{"key":"e_1_3_10_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2306441"},{"key":"e_1_3_10_15_2","doi-asserted-by":"crossref","unstructured":"Girard N Cho BC Spira AI et al: Risk factors for venous thromboembolism (VTE) among patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) receiving amivantamab plus lazertinib versus either agent alone. Presented at American Society of Clinical Oncology (ASCO) Annual Meeting Chicago IL June 2-6 2023","DOI":"10.1200\/JCO.2023.41.16_suppl.9137"},{"key":"e_1_3_10_16_2","unstructured":"European Medicines Agency: Concept paper for the development of a guideline on non-inferiority and equivalence comparisons in clinical trials. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/concept-paper-development-guideline-non-inferiority-equivalence-comparisons-clinical-trials_en.pdf"},{"key":"e_1_3_10_17_2","unstructured":"U.S. Food and Drug Administration: Non-inferiority clinical trials to establish effectiveness. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/non-inferiority-clinical-trials"},{"key":"e_1_3_10_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(20)30070-3"},{"key":"e_1_3_10_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3064"},{"key":"e_1_3_10_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2020.10.002"},{"key":"e_1_3_10_21_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrd4608"},{"key":"e_1_3_10_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jconrel.2019.10.040"},{"key":"e_1_3_10_23_2","unstructured":"Cho BC Felip E Spira A et al: Amivantamab plus lazertinib versus osimertinib as first-line treatment in EGFR-mutated advanced NSCLC. Presented at European Society for Medical Oncology (ESMO) Congress Madrid Spain October 20-24 2023"},{"key":"e_1_3_10_24_2","doi-asserted-by":"publisher","DOI":"10.1136\/jitc-2022-006072"},{"key":"e_1_3_10_25_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020007338"},{"key":"e_1_3_10_26_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1814630"},{"key":"e_1_3_10_27_2","doi-asserted-by":"crossref","unstructured":"Leighl NB Minchom AR Lee KH et al: Subcutaneous amivantamab administered every 4 weeks (Q4W) in patients with advanced solid malignancies: The phase Ib PALOMA study (ID 369). Presented at European Lung Cancer Congress (ELCC) Prague Czech Republic March 20-23 2024","DOI":"10.1016\/j.esmoop.2024.102585"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.24.01001","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,25]],"date-time":"2024-10-25T17:07:18Z","timestamp":1729876038000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.24.01001"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,20]]},"references-count":26,"journal-issue":{"issue":"30","published-print":{"date-parts":[[2024,10,20]]}},"alternative-id":["10.1200\/JCO.24.01001"],"URL":"https:\/\/doi.org\/10.1200\/jco.24.01001","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,20]]},"assertion":[{"value":"2024-05-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-29","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}