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A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2)

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

CR109264

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 2
  • Sites
    110 Sites
  • Status
    Recruiting

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 amivantamab SC-CF (Cohort 4).

CONDITIONS

  • Carcinoma, Non-Small-Cell Lung

ELIGIBILITY


Inclusion Criteria:

* 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. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility


Exclusion Criteria:

* 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


Inclusion Criteria:

* 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 requi

More...

DETAILS

LOCATIONS

Locations in:
United States, Brazil, China, France, Germany, Israel, Italy, South Korea, Malaysia, Spain, United Kingdom, Japan
Country (12) City or Province (110) Status
United States La Jolla University of California at San Diego
RECRUITING
United States Orange University of California Irvine
RECRUITING
United States Stanford Stanford Cancer Institute
RECRUITING
United States Washington Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
RECRUITING
United States Boca Raton Baptist Lynn Cancer Institute
COMPLETED
United States Miami Beach Mount Sinai Medical Center
RECRUITING
United States Orlando AdventHealth
RECRUITING
United States Tampa H. Lee Moffitt Cancer & Research Institute
RECRUITING
United States Westwood University of Kansas Cancer Center
RECRUITING
United States Boston Boston Medical Center
RECRUITING
United States Saint Louis Washington University School Of Medicine
RECRUITING
United States Hackensack Hackensack University Medical Center
RECRUITING
United States New Brunswick Rutgers Cancer Institute of New Jersey
RECRUITING
United States Charlotte Novant Health
RECRUITING
United States Winston-Salem Novant Health
RECRUITING
United States Cleveland Cleveland Clinic
COMPLETED
United States Mayfield Heights Cleveland Clinic
COMPLETED
United States Fairfax Virginia Cancer Specialists
RECRUITING
United States Everett Providence Regional Cancer Partnership
COMPLETED
United States Seattle Swedish Cancer Institute
RECRUITING
Brazil Barretos Fundacao Pio XII
RECRUITING
Brazil Belo Horizonte PERSONAL Oncologia de Precisao e Personalizada
RECRUITING
Brazil Londrina Instituto do Cancer de Londrina Hospital do Cancer de Londrina
RECRUITING
Brazil Porto Alegre Associacao Hospitalar Moinhos de Vento
RECRUITING
Brazil Rio de Janeiro Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Brazil Salvador Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Brazil Sao Paulo Hospital Alemao Oswaldo Cruz
RECRUITING
Brazil Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
China Changchun Jilin cancer hospital
RECRUITING
China Chengdu Sichuan Cancer Hospital
RECRUITING
China Chengdu West China Hospital Sichuan University
RECRUITING
China ChongQing The First Affiliated Hospital of PLA Army Medical University
RECRUITING
China Guangzhou The First Affiliated Hospital Sun Yat sen University
RECRUITING
China Hangzhou The First Affiliated Hospital Zhejiang University College of Medicine
RECRUITING
China Harbin Harbin medical university cancer hospital
RECRUITING
China Huizhou Huizhou Municipal Central Hospital
RECRUITING
China Shanghai Fudan University Shanghai Cancer Center
RECRUITING
China Tianjin Tianjin Medical University General Hospital
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
China Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
China Wuxi Hospital of Jiangnan University
COMPLETED
China XI An The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
France Caen Cedex 05 Centre Francois Baclesse
RECRUITING
France Nîmes Institut de Cancérologie du Gard
RECRUITING
France PARIS Cedex 5 Institut Curie
RECRUITING
France Saint-Herblain Cedex Institut de cancerologie de l'ouest
RECRUITING
France Villejuif Cedex Gustave Roussy
RECRUITING
Germany Grosshandorf LungenClinic Grosshansdorf GmbH
RECRUITING
Germany Immenhausen Lungenfachklinik Immenhausen
RECRUITING
Germany Koeln Universitaetsklinikum Koelnt
RECRUITING
Germany Wuerzburg Klinikum Würzburg Mitte gGmbH Standort Missioklinik
RECRUITING
Israel Kfar Saba Meir Medical Center
RECRUITING
Israel Petah Tikva Rabin Medical Center
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Italy Genova Policlinico Hospital San Martino- IRCCS for Oncology
RECRUITING
Italy Milano Ospedale San Raffaele
RECRUITING
Italy Milano ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Italy Monza Azienda Ospedaliera San Gerardo
RECRUITING
Italy Naples Azienda Ospedaliera Specialistica dei Colli
RECRUITING
South Korea Goyang-Si National Cancer Center
RECRUITING
South Korea Seongnam-si Seoul National University Bundang Hospital
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Severance Hospital Yonsei University Health System
RECRUITING
South Korea Seoul Asan Medical Center
RECRUITING
Malaysia Kuala Lumpur University Malaya Medical Centre
RECRUITING
Malaysia Kuantan Hospital Tengku Ampuan Afzan
RECRUITING
Malaysia Kuching Hospital Umum Sarawak
RECRUITING
Malaysia Petaling Jaya Beacon Hospital Sdn Bhd
RECRUITING
Spain Alacant General University Hospital of Alicantet
RECRUITING
Spain Barcelona Hosp. Del Mar
RECRUITING
Spain Barcelona Hosp. de La Santa Creu I Sant Pau
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Inst. Cat. Doncologia-H Duran I Reynals
RECRUITING
Spain Madrid Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Spain Madrid Hosp. Univ. Ramon Y Cajal
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Madrid Hosp. Univ. La Paz
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Valencia Hosp. Clinico Univ. de Valencia
RECRUITING
Spain Valencia Hosp. Gral. Univ. Valencia
RECRUITING
United Kingdom Devon Torbay Hospital-Devon
RECRUITING
United Kingdom Edinburgh Edinburgh Cancer Centre Western General
RECRUITING
United Kingdom Leicester Leicester Royal Infirmary
RECRUITING
United Kingdom London University College London Hospitals
RECRUITING
United Kingdom Nottingham Nottingham City Hospital
RECRUITING
United Kingdom Portsmouth Queen Alexandra Hospital
RECRUITING
China Yantai Yantai Yuhuangding Hospital
COMPLETED
Japan Himeji National Hospital Organization Himeji Medical Center
ACTIVE_NOT_RECRUITING
Japan Matsusaka Matsusaka Municipal Hospital
ACTIVE_NOT_RECRUITING
Japan Niigata Niigata Cancer Center Hospital
ACTIVE_NOT_RECRUITING
Japan Shizuoka Shizuoka Cancer Center
ACTIVE_NOT_RECRUITING
Japan Tokyo The Cancer Institute Hospital of JFCR
ACTIVE_NOT_RECRUITING
Japan Wakayama Wakayama Medical University Hospital
ACTIVE_NOT_RECRUITING
United States Baltimore Sidney Kimmel Cancer Center - Bayview Campus
RECRUITING
United States East Syracuse Hematology-Oncology Associates of CNY
COMPLETED
United States Cleveland Cleveland Clinic
COMPLETED
United States Warrensville Heights Cleveland Clinic
COMPLETED
United States Seattle Virginia Mason Medical Center
COMPLETED
Brazil Sao Paulo Impar Servicos Hospitalares SA Hospital Nove de Julho
RECRUITING
China Bao Ding Shi Affiliated Hospital of Hebei University
RECRUITING
China Hangzhou Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
China Liuzhou Liuzhou people's Hospital
COMPLETED
France Dijon Centre Georges-François Leclerc
COMPLETED
Germany Berlin Evangelische Lungenklinik Berlin
COMPLETED
Israel Haifa Rambam Medical Center
RECRUITING
Israel Jerusalem Shaare Zedek Medical Center
RECRUITING
Spain A Coruña Hosp Univ A Coruna
RECRUITING
Spain Malaga Hosp Regional Univ de Malaga
RECRUITING
United Kingdom Cheltenham Cheltenham General Hospital
COMPLETED
United States Salt Lake City The Huntsman Cancer Institute
COMPLETED
Show More
Geo Locations

32.84727, -117.2742

33.78779, -117.85311

37.42411, -122.16608

38.89511, -77.03637

26.3669, -80.13033

25.79065, -80.13005

28.53834, -81.37924

27.94752, -82.45843

39.04056, -94.6169

42.35843, -71.05977

38.62727, -90.19789

40.88593, -74.04347

40.48622, -74.45182

35.22709, -80.84313

36.09986, -80.24422

41.4995, -81.69541

41.51922, -81.4579

38.84622, -77.30637

47.97898, -122.20208

47.60621, -122.33207

-20.55722, -48.56778

-19.92083, -43.93778

-23.31028, -51.16278

-30.03306, -51.23

-22.90278, -43.2075

-12.97111, -38.51083

-23.5475, -46.63611

-23.5475, -46.63611

43.88, 125.32278

30.66667, 104.06667

30.66667, 104.06667

29.56278, 106.55278

23.11667, 113.25

30.29365, 120.16142

45.75, 126.65

23.11147, 114.41523

31.22222, 121.45806

39.14222, 117.17667

27.99942, 120.66682

30.58333, 114.26667

31.56887, 120.28857

34.2112799, 108.99608

49.18585, -0.35912

43.83333, 4.35

48.85341, 2.3488

47.21765, -1.64841

48.7939, 2.35992

53.651326, 10.2730016

51.42763, 9.48017

50.93333, 6.95

49.79391, 9.95121

32.175, 34.90694

32.08707, 34.88747

32.08227, 34.81065

44.40478, 8.94438

45.46427, 9.18951

45.46427, 9.18951

45.58005, 9.27246

40.85216, 14.26811

37.65639, 126.835

37.43861, 127.13778

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

3.1412, 101.68653

3.8077, 103.326

1.54999, 110.33333

3.10726, 101.60671

38.3616509, -0.489172

41.38879, 2.15899

41.38879, 2.15899

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

40.4165, -3.70256

40.4165, -3.70256

40.4165, -3.70256

37.38283, -5.97317

39.46975, -0.37739

39.46975, -0.37739

50.4823025, -3.5538193

55.95206, -3.19648

52.6386, -1.13169

51.50853, -0.12574

52.9536, -1.15047

50.79899, -1.09125

37.47649, 121.44081

34.81667, 134.7

34.5779758, 136.5276154

37.88637, 139.00589

34.98333, 138.38333

35.6895, 139.69171

34.23333, 135.16667

39.29038, -76.61219

43.06534, -76.07853

41.4995, -81.69541

41.43505, -81.53623

47.60621, -122.33207

-23.5475, -46.63611

38.8635899, 115.44969

30.29365, 120.16142

24.3239844, 109.4318605

47.31667, 5.01667

52.52437, 13.41053

32.81841, 34.9885

31.76904, 35.21633

43.37135, -8.396

36.72016, -4.42034

51.90006, -2.07972

40.76078, -111.89105

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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