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 (PALOMA-3)

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced or Metastatic Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Lazertinib; Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF); Drug: Amivantamab Intravenous

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1431
    • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
  • CABA, Argentina, C1122
    • IADT Instituto Argentino de Diagnostico y Tratamiento
  • Córdoba, Argentina, 5000
    • Sanatorio Allende
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Viedma, Argentina, R8500ACE
    • Clinica Viedma
• Australia
  • Adelaide, Australia, 5000
    • Cancer Research SA
  • Camperdown, Australia, 2050
    • Chris O'Brien Lifehouse
  • Melbourne, Australia, 3000
    • Peter MacCallum Cancer Centre
  • Murdoch, Australia, 6150
    • St John of God Hospital Murdoch
  • Westmead, Australia, 2145
    • Westmead Hospital
  • Woolloongabba, Australia, 4102
    • Princess Alexandra Hospital
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII
  • Belo Horizonte, Brazil, 30110-017
    • Cetus Oncologia
  • Curitiba, Brazil, 80810-050
    • Instituto Cionc de Ensino e Pesquisa S/S
  • Florianópolis, Brazil, 88020-210
    • Ynova Pesquisa Clinica
  • Ipatinga, Brazil, 35162 189
    • Fundacao Sao Francisco Xavier HMC Unidade de Oncologia
  • Pelotas, Brazil, 96020 080
    • UPCO Unidade de Pesquisa Clinica em Oncologia
  • Porto Alegre, Brazil, 90610-000
    • Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS
  • Rio de Janeiro, Brazil, 22061-080
    • Impar Servicos Hospitalares S/A
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Rio de Janeiro, Brazil, 22281 100
    • Instituto D Or de Pesquisa e Ensino IDOR
  • Salvador, Brazil, 40170 110
    • Nucleo de Oncologia da Bahia
  • Santo André, Brazil, 09060-650
    • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • São Paulo, Brazil, 04014-002
    • Núcleo de Pesquisa São Camilo
  • São Paulo, Brazil, 04543-000
    • Onco Star Sp Oncologia Ltda
  • São Paulo, Brazil, 05652 900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01409-002
    • Impar Servicos Hospitalares SA Hospital Nove de Julho
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Hospital
• China
  • Beijing, China, 101149
    • Beijing Chest Hospital, Capital Medical University
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital Capital Medical University
  • Beijing, China, 100038
    • Beijing Shijitan Hospital, Capital Medical University
  • Beijing, China, 200240
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Changchun, China, 130012
    • Jilin Cancer Hospital
  • Changzhou, China, 213004
    • The First People's Hospital of Changzhou
  • Chengdu, China, 610041
    • Sichuan Cancer Hospital
  • Chengdu, China, 610047
    • West China Hospital Sichuan University
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Chongqing, China, 400038
    • Southwest Hospital
  • Ganzhou, China, 341000
    • First Affiliated Hospital of Gannan Medical University
  • Guangzhou, China, 510000
    • Sun Yat-sen Memorial Hospital Sun Yat-sen University
  • Guangzhou, China, 510080
    • The First Affiliated Hospital Sun Yat sen University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University College of Medicine
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Huizhou, China, 516001
    • Huizhou Municipal Central Hospital
  • Huizhou, China, 516003
    • Huizhou First Hospital
  • Liuzhou, China, 545026
    • Liuzhou People's Hospital
  • Nanchong, China, 637100
    • Affiliated Hospital of North Sichuan Medical College
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110004
    • Shengjing Hospital of China Medical University
  • Shenzhen, China, 518055
    • Shenzhen University General Hospital
  • Shenzhen, China, 518001
    • Shenzhen People s Hospital
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital
  • Wuhan, China, 430022
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xian Jiaotong University
  • Xiangyang, China, 441021
    • Xiangyang Central Hospital
  • Yantai, China, 264000
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• France
  • La Tronche, France, 38700
    • CHU Grenoble
  • Lille, France, 59000
    • Institute Coeur Poumon
  • Limoges, France, 87000
    • CHU de Limoges Hopital Dupuytren
  • Marseille, France, 13915
    • Hopital Nord
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Georgsmarienhütte, Germany, 49124
    • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
  • Giessen, Germany, 35392
    • Universitaetsklinikum Giessen und Marburg GmbH
  • Münster, Germany, 48149
    • Münster University Hospital
  • Recklinghausen, Germany, 45659
    • Oncologianova GmbH
  • Weinsberg, Germany, 74189
    • Onkologische Schwerpunktpraxis
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center
• Italy
  • Bari, Italy, 70124
    • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
  • Bologna, Italy, 40138
    • A O U Sant Orsola Malpighi
  • Milan, Italy, 20141
    • European Institute of Oncology
  • Orbassano, Italy, 10043
    • AOU San Luigi Gonzaga
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto - IRCCS
  • Ravenna, Italy, 48121
    • Ospedale S. Maria Delle Croci
  • Roma, Italy, 00152
    • A.O. San Camillo Forlanini
  • Rome, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• Japan
  • Chūōku, Japan, 104 0045
    • National Cancer Center Hospital
  • Himeji, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Hirakata, Japan, 573 1191
    • Kansai Medical University Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kurashiki, Japan, 710-8602
    • Kurashiki Central Hospital
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Matsusaka, Japan, 515-8544
    • Matsusaka Municipal Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 700 8558
    • Okayama University Hospital
  • Osaka, Japan, 541 8567
    • Osaka International Cancer Institute
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Shizuoka, Japan, 411 8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Toyonaka-shi, Japan, 560-8552
    • National Hospital Organization Osaka Toneyama Medical Center
  • Wakayama, Japan, 641 8510
    • Wakayama Medical University Hospital
  • Yamaguchi, Japan, 740-8510
    • National Hospital Organization Iwakuni Clinical Center
  • Yamaguchi, Japan, 755-0241
    • National Hospital Organization Yamaguchi Ube Medical Center
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 50450
    • Prince Court Medical Centre
  • Kuala Lumpur, Malaysia, 59100
    • Pantai Hospital Kuala Lumpur
  • Kuching, Malaysia, 93586
    • Hospital Umum Sarawak
  • Petaling Jaya, Malaysia, 46050
    • Beacon Hospital Sdn Bhd
  • Petaling Jaya, Malaysia, 47500
    • Sunway Medical Centre
• Poland
  • Bydgoszcz, Poland, 85 796
    • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalityczny im. Jana Pawla II
  • Otwock, Poland, 05 400
    • Mazowieckie Centrum Leczenia Chorob Pluc
  • Poznan, Poland, 60-693
    • Private Specialist Hospitals - MedPolonia
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz, SA
  • Lisbon, Portugal, 1998-018
    • Hosp. Cuf Descobertas
  • Senhora da Hora, Portugal, 4464-513
    • Ulsm - Hosp. Pedro Hispano
• South Korea
  • Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center, CHA University
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Gyeongsangnam-do, South Korea, 52727
    • Gyeongsang National University Hospital
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Alicante, Spain, 03010
    • Hosp. Gral. Univ. de Alicante
  • Barcelona, Spain, 8028
    • Hosp. Univ. Quiron Dexeus
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • Córdoba, Spain, 14004
    • Hosp Reina Sofia
  • Las Palmas de Gran Canaria, Spain, 35016
    • Hosp. Univ. Insular de Gran Canaria
  • Lugo, Spain, 27003
    • Hosp. Univ. Lucus Augusti
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28009
    • Hosp. Gral. Univ. Gregorio Maranon
  • Majadahonda, Spain, 28222
    • Hosp. Univ. Pta. de Hierro Majadahonda
  • Málaga, Spain, 29011
    • Hosp Regional Univ de Malaga
  • Oviedo, Spain, 33011
    • Hosp. Univ. Central de Asturias
  • Palma de Mallorca, Spain, 07120
    • Hosp. Univ. Son Espases
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 833
    • Chang Kung Memorial Hospital
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 403
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taipei, Taiwan, 106
    • National Taiwan University Cancer Center
  • Taoyuan, Taiwan, 33382
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital and Medical College
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Adana City Hospital
  • Adana, Turkey (Türkiye), 01120
    • Adana Baskent Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34457
    • Acıbadem Maslak Hospital
  • Izmir, Turkey (Türkiye), 35330
    • Dokuz Eylul University Medical Faculty
  • Izmir, Turkey (Türkiye), 35575
    • IEU Medical Point Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Medical Park Samsun Hastanesi
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Newcastle Freeman Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Duarte
    • Irvine, California, United States, 92618
      • City of Hope Orange County Lennar Foundation Cancer Center
    • Long Beach, California, United States, 90813
      • City of Hope Long Beach Elm
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Baptist Lynn Cancer Institute
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health Laura and Isaac Perlmutter Cancer Center
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Providence Oncology and Hematology Care Clinic Westside
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Lazertinib with Amivantamab SC-CF; Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.	Drug: Lazertinib; Lazertinib tablets will be administered orally.; Other Names: JNJ-73841937; YH25448; Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF); Amivantamab injection will be administered subcutaneously by manual injection.; Other Names: JNJ-61186372
Experimental: Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion; Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.	Drug: Lazertinib; Lazertinib tablets will be administered orally.; Other Names: JNJ-73841937; YH25448; Drug: Amivantamab Intravenous; Amivantamab will be administered by IV infusion.; Other Names: JNJ-61186372

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State	Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.	Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab	Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.	Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2	AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.	Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Up to 3 years 4 months
Progression-Free Survival (PFS)	Up to 3 years 4 months
Duration of Response (DOR)	Up to 3 years 4 months
Time to Response (TTR)	Up to 3 years 4 months
Number of Participants With Adverse Events (AEs)	Up to 3 years 4 months
Number of Participants With AEs by Severity	Up to 3 years 4 months
Number of Participants With Clinical Laboratory Abnormalities	Up to 3 years 4 months
Number of Participants With Clinical Laboratory Abnormalities by Severity	Up to 3 years 4 months
Number of Participants With Infusion Related Reactions (IRRs)	Up to 3 years 4 months
Number of Participants With IRRs by Severity	Up to 3 years 4 months
For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1	Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1	Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Model-Predicted Area Under the Concentration Time Curve of Amivantamab at Steady State From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 4	Cycle 4: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hrs post-dose on Day 1; Arm B: preinfusion, EOI+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
Percentage of Participants With Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies	Up to 3 years 4 months
Percentage of Participants With Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)	Up to 3 years 4 months
Change From Baseline in Therapy Administration Satisfaction Questionnaire (TASQ) as Assessed Over Time	From baseline (Day 1, Cycle 1) to 3 years 4 months (each cycle of 28 days)
Participant Chair Time	Up to 3 years 4 months
Participant Chair Time in Treatment Room	Up to 3 years 4 months
Duration of Treatment Administration	Up to 3 years 4 months
Active Health Care Professional (HCP) Time For Drug Preparation, Treatment Administration and Post-treatment Monitoring	Up to 3 years 4 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Leighl NB, Akamatsu H, Lim SM, Cheng Y, Minchom AR, Marmarelis ME, Sanborn RE, Chih-Hsin Yang J, Liu B, John T, Massuti B, Spira AI, Lee SH, Wang J, Li J, Liu C, Novello S, Kondo M, Tamiya M, Korbenfeld E, Moskovitz M, Han JY, Alexander M, Joshi R, Felip E, Voon PJ, Danchaivijitr P, Hsu PC, Silva Melo Cruz FJ, Wehler T, Greillier L, Teixeira E, Nguyen D, Sabari JK, Qin A, Kowalski D, Sendur MAN, Xie J, Ghosh D, Alhadab A, Haddish-Berhane N, Clemens PL, Lorenzini P, Verheijen RB, Gamil M, Bauml JM, Baig M, Passaro A; PALOMA-3 Investigators. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605. doi: 10.1200/JCO.24.01001. Epub 2024 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): January 3, 2024
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; amivantamab; lazertinib
• Other Study ID Numbers: CR109211; 2022-000525-25 (EudraCT Number); 61186372NSC3004 (Other Identifier: Janssen Research & Development, LLC); 2024-512045-16-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No