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 Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1431
    • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • Caba, Argentina, C1122
    • IADT Instituto Argentino de Diagnostico y Tratamiento
  • Ciudad Autonoma de Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
  • Cordoba, Argentina, 5000
    • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Cordoba, Argentina, 5000
    • Sanatorio Allende
  • 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
  • Florianopolis, 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 Assistencia-Hospital Sao Lucas da PUCRS
  • Rio de Janeiro, Brazil, 22281-100
    • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • Rio de Janeiro, Brazil, 22061-080
    • Impar Serviços Hospitalares S/A
  • Rio de Janeiro, Brazil, 22250-905
    • Oncoclinicas Rio de Janeiro S A
  • Salvador, Brazil, 40170 110
    • Nucleo de Oncologia da Bahia
  • Santo Andre, Brazil, 09060-650
    • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • Sao Paulo, Brazil, 01409-002
    • Impar Servicos Hospitalares SA - Hospital Nove de Julho
  • São Paulo, Brazil, 05652-900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 04014-002
    • Núcleo de Pesquisa São Camilo
  • São Paulo, Brazil, 04543-000
    • Onco Star Sp Oncologia Ltda
• 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, 400038
    • Southwest Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Ganzhou, China, 341000
    • First Affiliated hospital of GANNAN Medical University
  • Guang Zhou, China, 510080
    • The First Affiliated Hospital, Sun Yat-sen University
  • Guangzhou, China, 510000
    • Sun Yat-sen Memorial Hospital Sun Yat-sen University
  • Hang Zhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University College 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
  • Shen Zhen Shi, China, 518001
    • ShenZhen People's Hospital
  • Shenyang, China, 110004
    • Shengjing Hospital of China Medical University
  • Shenzhen, China, 518055
    • Shenzhen University General 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 Xi'an 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 Cedex 20, France, 13915
    • Hôpital 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
  • Milano, 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
  • Chuo-Ku, 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-shi, 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
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 10408
    • National Cancer Center
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of, 13496
    • CHA Bundang Medical Center, CHA University
  • Gyeongsangnam-do, Korea, Republic of, 52727
    • Gyeongsang National University Hospital
  • Jeollanam-do, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung 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
  • Warszawa, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz, SA
  • Lisboa, Portugal, 1998-018
    • Hosp. Cuf Descobertas
  • Senhora da Hora,, Portugal, 4464-513
    • Hospital Pedro Hispano
• Spain
  • A Coruña, Spain, 15006
    • Hospital Teresa Herrera
  • Alicante, Spain, 03010
    • Hosp. Gral. Univ. de Alicante
  • Barcelona, Spain, 08035
    • Hosp. Univ. Vall D Hebron
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Barcelona, Spain, 8028
    • Hosp. Univ. Quiron Dexeus
  • 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
  • Malaga, Spain, 29010
    • Hosp. Regional Univ. de Malaga
  • Oviedo, Spain, 33006
    • Hosp. Univ. Central de Asturias
  • Palma de Mallorca, Spain, 07120
    • Hosp. Univ. Son Espases
  • Sevilla, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 833
    • Chang Kung 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 City, 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
  • Chiangmai, Thailand, 50200
    • Chiang Mai University
• Turkey
  • Adana, Turkey, 01060
    • Adana City Hospital
  • Adana, Turkey, 01120
    • Adana Baskent Hospital
  • Ankara, Turkey, 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey, 06560
    • Gazi University Hospital
  • Ankara, Turkey, 06800
    • Ankara Bilkent City Hospital
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34457
    • Acıbadem Maslak Hospital
  • Izmir, Turkey, 35330
    • Dokuz Eylul University Medical Faculty
  • Izmir, Turkey, 35575
    • IEU Medical Point Hospital
  • Samsun, Turkey, 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
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Health Laura and Isaac Perlmutter Cancer 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 mg will be administered orally once daily. Participants will receive Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 milligrams (mg)/ 2240 mg depending on the body weight by manual injection.	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.	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
Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2	AUC(Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15, will be reported.	Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)
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 on Cycle 4 Day 1	Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.	Cycle 4 Day 1 (28 days cycle)
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1	Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.	Cycle 2 Day 1 (28 days cycle)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1).	Up to 1 year 11 months
Progression-Free Survival (PFS)	PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.	Up to 1 year 11 months
Duration of Response (DOR)	The DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR.	Up to 1 year 11 months
Time to Response (TTR)	Time to response (that is time to first response) is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, as defined by BICR using RECIST version 1.1., for participants who have PR or CR as their best response.	Up to 1 year 11 months
Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention.	Up to 1 year 11 months
Number of Participants with AEs by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 1 year 11 months
Number of Participants Infusion Related Reactions (IRRs)	Number of participants with IRRs will be reported.	Up to 1 year 11 months
Number of Participants with Infusion Related Reactions (IRRs) by Severity	Number of participants with IRRs by severity will be reported.	Up to 1 year 11 months
Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4	Model-predicted AUC(Day 1-15) defined as area under the concentration time curve from Cycle 4 Day 1 to Day 15, will be reported.	From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)
Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies	Percentage of participants with presence of anti-amivantamab antibody anti-rHuPH20 antibodies will be reported.	Up to 1 year 11 months
Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)	Percentage of participants with cancer therapy satisfaction in will be assessed using the modified TASQ. The modified TASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.	Up to 1 year 11 months
Change from Baseline in TASQ as Assessed Over Time	Change from baseline in TASQ as assessed Over time will be reported. The modified TASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.	Up to 1 year 11 months
Participant Chair Time	Participant chair time will be assessed by time and motion analysis.	Up to 1 year 11 months
Duration of Treatment Administration	Duration of treatment administration will be assessed by time and motion analysis.	Up to 1 year 11 months
Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring	Active health care professional time for drug preparation, treatment administration, and posttreatment monitoring will be assessed by time and motion analysis.	Up to 1 year 11 months
Participant Time in Treatment Room	Participant time in treatment room will be assessed by time and motion analysis.	Up to 1 year 11 months
Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical laboratory abnormalities (serum Chemistry, hematology, coagulation, and urinalysis) will be reported.	Up to 1 year 11 months
Number of Participants with Clinical Laboratory Abnormalities by Severity	Number of participants with clinical laboratory abnormalities by severity (serum Chemistry, hematology, coagulation, and urinalysis) will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 1 year 11 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	The Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.	Cycle 2 Day 1 (28 days cycle)
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1	The Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.	Cycle 4 Day 1 (28 days cycle)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): January 3, 2024
• Study Completion (Estimated): January 9, 2025

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): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

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

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