AzTrials
AzTrials

Advanced or Metastatic Non-small Cell Lung CancerPhase 3PALOMA-3NCT05388669

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

A Phase 3 study testing Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) and Amivantamab Intravenous in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Janssen Research & Development, LLC at 187 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) and Amivantamab Intravenous
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
187 sitesin 20 countries
Study dates
5 Aug 2022to 30 Jun 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

187 sites in 20 countries.

187 sites in 20 countries

China32 sites

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, 100038

  • Beijing Friendship Hospital Capital Medical University

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Chest hospital, Capital medical university

    Beijing, 101149

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 200240

  • Jilin cancer hospital

    Changchun, 130012

  • The First People's Hospital Of Changzhou

    Changzhou, 213004

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital Sichuan University

    Chengdu, 610047

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Southwest Hospital

    Chongqing, 400038

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341000

  • Sun Yat-Sen Memorial Hospital Sun Yat-sen University

    Guangzhou, 510000

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin medical university cancer hospital

    Harbin, 150081

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • Huizhou First Hospital

    Huizhou, 516003

  • Liuzhou people's Hospital

    Liuzhou, 545026

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, 637100

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Shenzhen People s Hospital

    Shenzhen, 518001

  • Shenzhen university General Hospital

    Shenzhen, 518055

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

  • Xiangyang Central Hospital

    Xiangyang, 441021

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Japan18 sites

  • National Cancer Center Hospital

    Chūōku, 104 0045

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520

  • Kansai Medical University Hospital

    Hirakata, 573 1191

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kurashiki Central Hospital

    Kurashiki, 710-8602

  • Kurume University Hospital

    Kurume, 830-0011

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700 8558

  • Osaka International Cancer Institute

    Osaka, 541 8567

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Shizuoka Cancer Center

    Shizuoka, 411 8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka-shi, 560-8552

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

  • National Hospital Organization Iwakuni Clinical Center

    Yamaguchi, 740-8510

  • National Hospital Organization Yamaguchi Ube Medical Center

    Yamaguchi, 755-0241

Other trials in Japan

United States17 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Baptist Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • National Jewish Health

    Denver, Colorado, 80206

  • City of Hope Duarte

    Duarte, California, 91010

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

  • University of Kansas

    Kansas City, Kansas, 66160

  • City of Hope Long Beach Elm

    Long Beach, California, 90813

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Orlando Health

    Orlando, Florida, 32806

  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, 97225

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

Brazil16 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Cetus Oncologia

    Belo Horizonte, 30110-017

  • Instituto Cionc de Ensino e Pesquisa S/S

    Curitiba, 80810-050

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210

  • Fundacao Sao Francisco Xavier HMC Unidade de Oncologia

    Ipatinga, 35162 189

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Impar Servicos Hospitalares S/A

    Rio de Janeiro, 22061-080

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100

  • Nucleo de Oncologia da Bahia

    Salvador, 40170 110

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

  • Impar Servicos Hospitalares SA Hospital Nove de Julho

    São Paulo, 01409-002

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002

  • Onco Star SP Oncologia Ltda

    São Paulo, 04543-000

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

Other trials in Brazil

Spain16 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 8028

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28009

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222

  • Hosp Regional Univ de Malaga

    Málaga, 29011

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011

  • Hosp. Univ. Son Espases

    Palma de Mallorca, 07120

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)11 sites

  • Adana City Hospital

    Adana, 01060

  • Adana Baskent Hospital

    Adana, 01120

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Gazi University Hospital

    Ankara, 06560

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Acıbadem Maslak Hospital

    Istanbul, 34457

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330

  • IEU Medical Point Hospital

    Izmir, 35575

  • Medical Park Samsun Hastanesi

    Samsun, 55200

Other trials in Turkey (Türkiye)

Italy9 sites

  • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • A O U Sant Orsola Malpighi

    Bologna, 40138

  • European Institute of Oncology

    Milan, 20141

  • Aou San Luigi Gonzaga

    Orbassano, 10043

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • A.O. San Camillo Forlanini

    Roma, 00152

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

South Korea9 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, 13496

  • GyeongSang National University Hospital

    Gyeongsangnam-do, 52727

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Kung Memorial Hospital

    Kaohsiung City, 833

  • Chung Shan Medical University Hospital

    Taichung, 403

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10048

  • National Taiwan University Cancer Center

    Taipei, 106

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33382

Other trials in Taiwan

Argentina6 sites

  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

    Buenos Aires, 1431

  • IADT Instituto Argentino de Diagnostico y Tratamiento

    CABA, C1122

  • Centro Oncológico Korben

    Chabas, C1425

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Sanatorio Allende

    Córdoba, 5000

  • Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

Australia6 sites

  • Cancer Research SA

    Adelaide, 5000

  • Chris O'Brien Lifehouse

    Camperdown, 2050

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • St John of God Hospital Murdoch

    Murdoch, 6150

  • Westmead Hospital

    Westmead, 2145

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Germany6 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

    Georgsmarienhütte, 49124

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

  • Munster University Hospital

    Münster, 48149

  • Oncologianova GmbH

    Recklinghausen, 45659

  • Onkologische Schwerpunktpraxis

    Weinsberg, 74189

Other trials in Germany

Malaysia6 sites

  • Prince Court Medical Centre

    Kuala Lumpur, 50450

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, 59100

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Umum Sarawak

    Kuching, 93586

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050

  • Sunway Medical Centre

    Petaling Jaya, 47500

Other trials in Malaysia

Israel5 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Shaare Zedek Medical Center

    Yeruham, 91031

Other trials in Israel

Poland5 sites

  • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85 796

  • Krakowski Szpital Specjalityczny im. Jana Pawla II

    Krakow, 31-202

  • Mazowieckie Centrum Leczenia Chorob Pluc

    Otwock, 05 400

  • Private Specialist Hospitals - MedPolonia

    Poznan, 60-693

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

France4 sites

  • CHU Grenoble

    La Tronche, 38700

  • Institute Coeur Poumon

    Lille, 59000

  • CHU de Limoges Hopital Dupuytren

    Limoges, 87000

  • Hopital Nord

    Marseille, 13915

Other trials in France

Portugal4 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital da Luz, SA

    Lisbon, 1500-650

  • Hosp. Cuf Descobertas

    Lisbon, 1998-018

  • Ulsm - Hosp. Pedro Hispano

    Senhora da Hora, 4464-513

Other trials in Portugal

United Kingdom4 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Imperial College Healthcare

    London, W2 1NY

  • Newcastle Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Thailand3 sites

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

Canada2 sites

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

Official title: 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.

Being tested
Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LazertinibDrug

    Also called JNJ-73841937, YH25448

    Lazertinib tablets will be administered orally.

  • Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)Drug

    Also called JNJ-61186372

    Amivantamab injection will be administered subcutaneously by manual injection.

  • Amivantamab IntravenousDrug

    Also called JNJ-61186372

    Amivantamab will be administered by IV infusion.

Study groups in NCT05388669
Study groupRoleWhat they receive
Arm A: Lazertinib with Amivantamab SC-CFExperimentalLazertinib 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.
Receives: Drug: Lazertinib; Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Arm B: Lazertinib with Amivantamab Intravenous (IV) InfusionExperimentalLazertinib 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.
Receives: Drug: Lazertinib; Drug: Amivantamab Intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)

  2. 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.

    Measured: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)

  3. 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.

    Measured: 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 outcomes (20)

  1. Objective Response Rate (ORR)

    Measured: Up to 3 years 4 months

  2. Progression-Free Survival (PFS)

    Measured: Up to 3 years 4 months

  3. Duration of Response (DOR)

    Measured: Up to 3 years 4 months

  4. Time to Response (TTR)

    Measured: Up to 3 years 4 months

  5. Number of Participants With Adverse Events (AEs)

    Measured: Up to 3 years 4 months

  6. Number of Participants With AEs by Severity

    Measured: Up to 3 years 4 months

  7. Number of Participants With Clinical Laboratory Abnormalities

    Measured: Up to 3 years 4 months

  8. Number of Participants With Clinical Laboratory Abnormalities by Severity

    Measured: Up to 3 years 4 months

  9. Number of Participants With Infusion Related Reactions (IRRs)

    Measured: Up to 3 years 4 months

  10. Number of Participants With IRRs by Severity

    Measured: Up to 3 years 4 months

  11. 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

    Measured: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)

  12. For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1

    Measured: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)

  13. 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

    Measured: 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

  14. Percentage of Participants With Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies

    Measured: Up to 3 years 4 months

  15. Percentage of Participants With Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)

    Measured: Up to 3 years 4 months

  16. Change From Baseline in Therapy Administration Satisfaction Questionnaire (TASQ) as Assessed Over Time

    Measured: From baseline (Day 1, Cycle 1) to 3 years 4 months (each cycle of 28 days)

  17. Participant Chair Time

    Measured: Up to 3 years 4 months

  18. Participant Chair Time in Treatment Room

    Measured: Up to 3 years 4 months

  19. Duration of Treatment Administration

    Measured: Up to 3 years 4 months

  20. Active Health Care Professional (HCP) Time For Drug Preparation, Treatment Administration and Post-treatment Monitoring

    Measured: Up to 3 years 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start5 Aug 2022
  3. Primary completion3 Jan 2024
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388669
Sponsor's protocol ID
CR109211
Other IDs
61186372NSC3004, 2022-000525-25, 2024-512045-16-00
Acronym
PALOMA-3
Status last verified
Nov 2026
First submitted
19 May 2022
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • Leighl NB, Passaro A, Akamatsu H, Spira AI, Nguyen D, Qin A, Schuchard J, Gamil M, Baig M, Alexander M. Plain language summary of subcutaneous vs IV amivantamab plus lazertinib in EGFR-altered non-small-cell lung cancer. Future Oncol. 2026 Aug 24:1-17. doi: 10.1080/14796694.2026.2709936. Online ahead of print.

    PubMed 42635093

  • 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.

    PubMed 38857463

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) and Amivantamab Intravenous in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Janssen Research & Development, LLC at 187 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in China, Japan, United States, Brazil, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388669, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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