A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal

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 February 20, 2025

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CR109264

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2

2
Sites
109 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:

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 (109)	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	East Syracuse Hemotology Oncology Associates of CNY	COMPLETED
United States	Charlotte Novant Health	RECRUITING
United States	Winston-Salem Novant Health	RECRUITING
United States	Cleveland Cleveland Clinic	RECRUITING
United States	Cleveland Cleveland Clinic	COMPLETED
United States	Mayfield Heights Cleveland Clinic	COMPLETED
United States	Warrensville Heights Cleveland Clinic	RECRUITING
United States	Salt Lake City The Huntsman Cancer Institute	RECRUITING
United States	Fairfax Virginia Cancer Specialists	RECRUITING
United States	Everett Providence Regional Cancer Partnership	COMPLETED
United States	Seattle Virginia Mason Medical Center	RECRUITING
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 Impar Servicos Hospitalares SA - Hospital Nove de Julho	RECRUITING
Brazil	Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center	RECRUITING
China	Baoding Affiliated Hospital of Hebei University	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	Hangzhou Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	RECRUITING
China	Harbin Harbin medical university cancer hospital	RECRUITING
China	Huizhou Huizhou Municipal Central Hospital	RECRUITING
China	Liuzhou Liuzhou people's 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	Dijon Centre Georges-François Leclerc	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	Berlin Evangelische Lungenklinik Berlin	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	Haifa Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital	RECRUITING
Israel	Jerusalem Shaare Zedek Medical Center	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	A Coruña Hosp. Univ. A Coruna	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	Malaga Hosp. Regional Univ. de Malaga	RECRUITING
Spain	Sevilla Hosp. Virgen Macarena	RECRUITING
Spain	Valencia Hosp. Clinico Univ. de Valencia	RECRUITING
Spain	Valencia Hosp. Gral. Univ. Valencia	RECRUITING
United Kingdom	Cheltenham Cheltenham General Hospital	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

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

43.06534, -76.07853

35.22709, -80.84313

36.09986, -80.24422

41.4995, -81.69541

41.51922, -81.4579

41.43505, -81.53623

40.76078, -111.89105

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

38.85111, 115.49028

43.88, 125.32278

30.66667, 104.06667

29.56278, 106.55278

23.11667, 113.25

30.29365, 120.16142

45.75, 126.65

23.11147, 114.41523

24.3239844, 109.4318605

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

47.31667, 5.01667

43.83333, 4.35

48.85341, 2.3488

47.21765, -1.64841

48.7939, 2.35992

52.52437, 13.41053

53.651326, 10.2730016

51.42763, 9.48017

50.93333, 6.95

49.79391, 9.95121

32.81841, 34.9885

31.76904, 35.21633

32.175, 34.90694

32.08707, 34.88747

32.08227, 34.81065

44.40478, 8.94438

45.46427, 9.18951

45.58005, 9.27246

40.85216, 14.26811

37.65639, 126.835

37.43861, 127.13778

37.566, 126.9784

3.1412, 101.68653

3.8077, 103.326

1.54999, 110.33333

3.10726, 101.60671

43.37135, -8.396

38.3616509, -0.489172

41.38879, 2.15899

40.4165, -3.70256

36.72016, -4.42034

37.38283, -5.97317

39.46975, -0.37739

51.90006, -2.07972

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

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

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

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

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

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

43.06534, -76.07853

35.22709, -80.84313

36.09986, -80.24422

41.4995, -81.69541

41.4995, -81.69541

41.51922, -81.4579

41.43505, -81.53623

40.76078, -111.89105

38.84622, -77.30637

47.97898, -122.20208

47.60621, -122.33207

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

-23.5475, -46.63611

38.85111, 115.49028

43.88, 125.32278

30.66667, 104.06667

30.66667, 104.06667

29.56278, 106.55278

23.11667, 113.25

30.29365, 120.16142

30.29365, 120.16142

45.75, 126.65

23.11147, 114.41523

24.3239844, 109.4318605

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

47.31667, 5.01667

43.83333, 4.35

48.85341, 2.3488

47.21765, -1.64841

48.7939, 2.35992

52.52437, 13.41053

53.651326, 10.2730016

51.42763, 9.48017

50.93333, 6.95

49.79391, 9.95121

32.81841, 34.9885

31.76904, 35.21633

32.175, 34.90694

32.08707, 34.88747

32.08227, 34.81065

44.40478, 8.94438

45.46427, 9.18951