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AzTrials

Carcinoma, Non-small-Cell LungPhase 2PALOMA-2NCT05498428

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

A Phase 2 study testing Amivantamab, Lazertinib and Carboplatin in people with Carcinoma, Non-small-Cell Lung, run by Janssen Research & Development, LLC at 110 sites in 12 countries.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-small-Cell Lung
What is being tested?
Amivantamab, Lazertinib and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
110 sitesin 12 countries
Study dates
11 Nov 2022to 18 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by 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 states [US]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
  • All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
  • May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
  • Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
  • Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
  • A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility

Who cannot join

  • Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
  • Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
  • Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary
  • For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
  • Other clinically active liver disease of infectious origin
  • Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan
  • Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or equivalent) for at least 2 weeks prior to treatment allocation

Trial locations and contacts

110 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

110 sites in 12 countries

United States26 sites, 14 recruiting

  • Sidney Kimmel Cancer Center - Bayview Campus

    Baltimore, Maryland, 21224

    Recruiting

  • Baptist Lynn Cancer Institute

    Boca Raton, Florida, 33486

    Completed

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • Novant Health 1

    Charlotte, North Carolina, 28204

    Completed

  • Cleveland Clinic 1

    Cleveland, Ohio, 44111

    Completed

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Completed

  • Hematology-Oncology Associates of CNY

    East Syracuse, New York, 13057

    Completed

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Completed

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • University of California at San Diego

    La Jolla, California, 92093

    Recruiting

  • Cleveland Clinic 2

    Mayfield Heights, Ohio, 44124

    Completed

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • University of California Irvine

    Orange, California, 92868

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Recruiting

  • The Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Completed

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Completed

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Stanford Cancer Institute

    Stanford, California, 94305

    Recruiting

  • H. Lee Moffitt Cancer & Research Institute

    Tampa, Florida, 33612

    Completed

  • Cleveland Clinic 3

    Warrensville Heights, Ohio, 44122

    Completed

  • Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

  • Novant Health

    Winston-Salem, North Carolina, 27106

    Completed

Other trials in United States

China18 sites, 14 recruiting

  • Affiliated Hospital of Hebei University

    Baoding, 071051

    Completed

  • Jilin cancer hospital

    Changchun, 130000

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610047

    Recruiting

  • The First Affiliated Hospital of PLA Army Medical University

    Chongqing, 400038

    Recruiting

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510060

    Recruiting

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

    Recruiting

  • Harbin medical university cancer hospital

    Harbin, 150000

    Recruiting

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

    Recruiting

  • Liuzhou people's Hospital

    Liuzhou, 545006

    Completed

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

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

    Wuhan, 430022

    Recruiting

  • Hospital of Jiangnan University

    Wuxi, 214122

    Completed

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, 264000

    Completed

Other trials in China

Spain14 sites, 14 recruiting

  • Hosp Univ A Coruna

    A Coruña, 15006

    Recruiting

  • General University Hospital of Alicantet

    Alicante, 03010

    Recruiting

  • Hosp. Del Mar

    Barcelona, 08003

    Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 8908

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp. Univ. La Paz

    Madrid, 28046

    Recruiting

  • Hosp Regional Univ de Malaga

    Málaga, 29010

    Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009

    Recruiting

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

    Recruiting

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

    Recruiting

Other trials in Spain

Brazil9 sites, 8 recruiting

  • Fundacao Pio XII

    Barretos, 14784-400

    Recruiting

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130 090

    Recruiting

  • Hospital do Cancer de Londrina

    Londrina, 86015 520

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

    Recruiting

  • IDOR - Regional Rio de Janeiro

    Rio de Janeiro, 22281 100

    Recruiting

  • IDOR - Regional Bahia

    Salvador, 41253-190

    Recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327 001

    Recruiting

  • Impar Servicos Hospitalares SA Hospital Nove de Julho

    São Paulo, 01409-001

    Completed

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

    Recruiting

Other trials in Brazil

United Kingdom7 sites, 6 recruiting

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN

    Completed

  • Torbay Hospital-Devon

    Devon, TQ2 7AA

    Recruiting

  • Edinburgh Cancer Centre Western General

    Edinburgh, EH4 2XU

    Recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

    Recruiting

  • University College London Hospitals

    London, NW1 2PG

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Recruiting

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

    Recruiting

Other trials in United Kingdom

France6 sites, 5 recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Recruiting

  • Centre Georges-François Leclerc

    Dijon, 21079

    Completed

  • Institut de Cancérologie du Gard

    Nîmes, 30029

    Recruiting

  • Institut Curie

    Paris, 75248

    Recruiting

  • Institut de cancerologie de l'ouest

    Saint-Herblain, 44805

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Japan6 sites

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520

    Active, not recruiting

  • Saiseikai Matsusaka Municipal Hospital

    Matsusaka, 515 8544

    Active, not recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

    Active, not recruiting

  • Shizuoka Cancer Center

    Shizuoka, 411 8777

    Active, not recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

    Active, not recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

    Active, not recruiting

Other trials in Japan

Germany5 sites, 4 recruiting

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

    Completed

  • Universitaetsklinikum Koeln

    Cologne, 50937

    Recruiting

  • LungenClinic Grosshansdorf GmbH

    Grosshandorf, 22927

    Recruiting

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

    Recruiting

  • Klinikum Würzburg Mitte gGmbH Standort Missioklinik

    Würzburg, 97074

    Recruiting

Other trials in Germany

Israel5 sites, 4 recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Meir Medical Center

    Kfar Saba, 44281

    Completed

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Recruiting

Other trials in Israel

Italy5 sites, 5 recruiting

  • Policlinico Hospital San Martino- IRCCS for Oncology

    Genova, 16132

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • Azienda Ospedaliera San Gerardo

    Monza, 20090

    Recruiting

  • Azienda Ospedaliera Specialistica dei Colli

    Naples, 80131

    Recruiting

Other trials in Italy

South Korea5 sites, 4 recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Completed

Other trials in South Korea

Malaysia4 sites, 4 recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

    Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586

    Recruiting

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050

    Recruiting

Other trials in Malaysia

About this study

Official title: A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Being tested
Amivantamab, Lazertinib, Carboplatin, Pemetrexed, Direct Oral Anticoagulant (DOAC)
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.

  • AmivantamabDrug

    Also called JNJ-61186372

    Amivantamab will be administered subcutaneously by manual injection.

  • LazertinibDrug

    Also called JNJ-73841937; YH25448

    Lazertinib will be administered as an oral tablet.

  • CarboplatinDrug

    Carboplatin will be administrated by IV infusion.

  • PemetrexedDrug

    Pemetrexed will be administered by IV infusion.

  • Direct Oral Anticoagulant (DOAC)Drug

    DOAC will be administered orally.

  • Low Molecular Weight Heparin (LMWH)Drug

    LMWH will be administered subcutaneously.

Study groups in NCT05498428
Study groupRoleWhat they receive
Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + LazertinibExperimentalParticipants with treatment-naive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 19 deletion (exon19del) or exon 21 leucine 858 to arginine substitution (exon 21 L858R) mutation, will receive amivantamab SC-CF injection, 1600 milligrams (mg) or 2240 mg if body weight is greater than or equal to (>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily. Eligible participants will be given an option to enter long-term extension (LTE) phase and may continue to receive access to study treatment(s) within the study by transferring to the Drug Access (DA)-LTE Phase.
Receives: Drug: Amivantamab; Drug: Lazertinib
Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + ChemotherapyExperimentalParticipants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR exon20ins mutation will receive Amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle, starting with Cycle 2 along with pemetrexed 500 milligrams per meter square (mg/m^2) as intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and IV infusion carboplatin area under the concentration-time curve 5 milligrams per milliliters (mg/mL) per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Receives: Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+ChemotherapyExperimentalParticipants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Lazertinib 240 mg orally once daily starting Cycle 5 Day 1 when carboplatin is complete or sooner if carboplatin discontinued earlier than Cycle 4. Eligible participants will be given an option to enter LTE phase and DA-LTE Phase.
Receives: Drug: Amivantamab; Drug: Lazertinib; Drug: Carboplatin; Drug: Pemetrexed
Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+ChemotherapyExperimentalParticipants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Receives: Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed
Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)ExperimentalParticipants who were previously on amivantamab IV once every 2 weeks (Q2W) regimen as part of standard of care, for at least 8 weeks, either as monotherapy or combination with lazertinib, will receive amivantamab SC-CF injection 1600 mg and 2240 mg if body weight is greater than or equal to 80 kg. Participants who continue to benefit from study treatments, as determined by their investigator, may shift to the drug access (DA)-LTE phase.
Receives: Drug: Amivantamab; Drug: Lazertinib
Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + LazertinibExperimentalParticipants with treatment-naïve locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation will receive amivantamab SC-CF induction with 1,600 mg (or 2,240 mg if BW >=80 kg) on Cycle 1 Days 1, 8, 15, and 22, starting with Cycle 2 on Day 1 of each next 28-day cycle, amivantamab SC-CF (160 mg/mL co-formulated with rHuPH20) by manual injection at 3,520 mg (or 4,640 mg if BW >=80 kg); along with lazertinib 240 mg by mouth once daily from Cycle 1 Day 1. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Receives: Drug: Amivantamab; Drug: Lazertinib
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+AnticoagulantExperimentalParticipants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation treated will receive will receive amivantamab SC-CF injection, 1600 milligrams (mg) and 2240 mg if body weight is greater than or equal to (>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily from Cycle 1 Day 1. Participants will additionally take prophylactic anticoagulation with a direct oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH) for the first four months of study treatment (from Day 1 through Day 120) with the combination of amivantamab and lazertinib. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Receives: Drug: Amivantamab; Drug: Lazertinib; Drug: Direct Oral Anticoagulant (DOAC); Drug: Low Molecular Weight Heparin (LMWH)
Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+ChemotherapyExperimentalParticipants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after the combination of amivantamab and lazertinib will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Receives: Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)

    ORR based on INV will be reported. ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.

    Measured: Up to 1 year 6 months

  2. Cohort 4: Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

    Measured: Up to approximately 4 years and 9 months

  3. Cohort 4: Number of Participants with AEs by Severity

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs 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.

    Measured: Up to approximately 4 years and 9 months

  4. Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values

    Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.

    Measured: Up to approximately 4 years and 9 months

  5. Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity

    Number of participants with laboratory values abnormalities which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities will be graded according to the 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.

    Measured: Up to approximately 4 years and 9 months

Secondary outcomes (17)

  1. All Cohorts Except Cohort 4: Number of Participants with AEs

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

    Measured: Up to 1 year 6 months

  2. All Cohorts Except Cohort 4: Number of Participants with AEs by Severity

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs 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.

    Measured: Up to 1 year 6 months

  3. All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values

    Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.

    Measured: Up to 1 year 6 months

  4. All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity

    Number of participants with abnormalities in clinical laboratory values which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities 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.

    Measured: Up to 1 year 6 months

  5. All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)

    ORR based on ICR will be reported. The ORR is defined as the percentage of participants who achieve a CR or PR, based on RECIST version 1.1, as confirmed by ICR.

    Measured: Up to 1 year 6 months

  6. All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)

    DoR based on INV 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.

    Measured: Up to 1 year 6 months

  7. All Cohorts Except Cohort 4: Time to Response (TTR) Based on INV

    TTR (that is, time to first response) based on INV is defined as the time from the first dose of study treatment to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, based on RECIST version 1.1., for participants who have PR or CR as their best response.

    Measured: Up to 1 year 6 months

  8. All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants achieving CR or PR, or durable standard deviation (SD) of a duration of at least 11 weeks as defined by RECIST version 1.1.

    Measured: Up to 1 year 6 months

  9. All Cohorts Except Cohort 4: Progression-free Survival (PFS)

    The PFS is defined as the time from the first dose of study treatment until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.

    Measured: Up to 3 years

  10. All Cohorts Except Cohort 4: Overall Survival (OS)

    The OS is defined as the time from the first dose of study treatment until the date of death due to any cause.

    Measured: Up to approximately 4 years

  11. All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE)

    Number of participants with adverse events of VTE (pulmonary embolism and deep vein thrombosis) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

    Measured: Up to 1 year 6 months

  12. All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE) by Severity

    Number of participants with adverse events of VTE (pulmonary embolism and deep vein thrombosis) by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs 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).

    Measured: Up to 1 year 6 months

  13. All Cohorts Except Cohort 4: Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab

    Ctrough is defined as the serum concentration of amivantamab immediately prior to the next drug administration.

    Measured: Cycle 2 Day 1 of 28-day cycle

  14. Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV)

    Patient-reported outcome (PRO): Cancer therapy satisfaction will be assessed using the modified TASQ-IV. The modified TASQ is a 12-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. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.

    Measured: Up to 1 year 6 months

  15. Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC)

    PRO: Cancer therapy satisfaction will be assessed using the modified TASQ-SC. The modified TASQ is a 12-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. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.

    Measured: Up to 1 year 6 months

  16. Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Change (PGIC) Scale Score

    Patient-reported status as assessed by PGIC scale score will be reported. The PGIC is an assessment of the participant's overall sense of whether there has been a change since starting treatment. The PGIC is a 7-point response scale. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse.

    Measured: Up to 1 year 6 months

  17. Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score

    Patient-reported status as assessed by PGIS scale score will be reported. The PGIS is an assessment of lung cancer severity at a given point in time. The PGIS is a 5-point response scale. Participants will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe.

    Measured: Up to 1 year 6 months

Timeline

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

  1. First posted12 Aug 2022
  2. Study start11 Nov 2022
  3. Primary completion17 Aug 2027 (estimated)
  4. Study completion18 Aug 2028 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498428
Sponsor's protocol ID
CR109264
Other IDs
61186372NSC2002, 2022-000526-21, 2023-505065-91-00, 2023
Acronym
PALOMA-2
Status last verified
Nov 2026
First submitted
10 Aug 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amivantamab, Lazertinib and Carboplatin in people with Carcinoma, Non-small-Cell Lung, run by Janssen Research & Development, LLC at 110 sites in 12 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 7 inclusion and 7 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: looking for participants now, 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 110 sites in United States, China, Spain, Brazil, United Kingdom and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV) (time frame: Up to 1 year 6 months). The study lists 5 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 NCT05498428.

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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