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A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3)

Primary Purpose

Advanced or Metastatic Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lazertinib
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Amivantamab Intravenous
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started [US]) or an accredited local laboratory (sites outside of the US)
  • Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
  • Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)

Exclusion Criteria:

  • Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
  • Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
  • Participant has symptomatic or progressive brain metastases
  • Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
  • Participant has uncontrolled tumor-related pain
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Sites / Locations

  • City of Hope DuarteRecruiting
  • City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
  • City of Hope Long Beach ElmRecruiting
  • National Jewish HealthRecruiting
  • Baptist Lynn Cancer InstituteRecruiting
  • Orlando HealthRecruiting
  • University of KansasRecruiting
  • University of MichiganRecruiting
  • Astera Cancer CareRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Montefiore Medical CenterRecruiting
  • NYU Langone Health Laura and Isaac Perlmutter Cancer CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • Providence Oncology and Hematology Care Clinic - WestsideRecruiting
  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced MedicineRecruiting
  • Medical University of South CarolinaRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)Recruiting
  • IADT Instituto Argentino de Diagnostico y TratamientoRecruiting
  • Centro Oncológico KorbenRecruiting
  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion ClinicaRecruiting
  • Sanatorio AllendeRecruiting
  • Clínica ViedmaRecruiting
  • Cancer Research SARecruiting
  • Chris O'Brien LifehouseRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • St John of God Hospital MurdochRecruiting
  • Westmead HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Fundacao Pio XIIRecruiting
  • Cetus OncologiaRecruiting
  • Instituto Cionc de Ensino e Pesquisa S/SRecruiting
  • Ynova Pesquisa ClinicaRecruiting
  • Fundacao Sao Francisco Xavier HMC Unidade de OncologiaRecruiting
  • UPCO Unidade de Pesquisa Clinica em OncologiaRecruiting
  • União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRSRecruiting
  • Impar Servicos Hospitalares S/ARecruiting
  • Oncoclínicas Rio de Janeiro S.A.Recruiting
  • Instituto D'Or de Pesquisa e Ensino (IDOR)Recruiting
  • Nucleo de Oncologia da BahiaRecruiting
  • CEPHO - Centro de Estudos e Pesquisa de Hematologia e OncologiaRecruiting
  • Impar Servicos Hospitalares SA - Hospital Nove de JulhoRecruiting
  • Núcleo de Pesquisa São CamiloRecruiting
  • Onco Star SP Oncologia LtdaRecruiting
  • Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
  • The Ottawa Hospital Cancer CentreRecruiting
  • Princess Margaret HospitalRecruiting
  • Beijing Shijitan Hospital, Capital Medical UniversityRecruiting
  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • Beijing Chest hospital, Capital medical universityRecruiting
  • Cancer Hospital Chinese Academy of Medical SciencesRecruiting
  • Jilin cancer hospitalRecruiting
  • The First People's Hospital Of ChangzhouRecruiting
  • Sichuan Cancer HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Chongqing University Cancer HospitalRecruiting
  • Southwest HospitalRecruiting
  • First Affiliated Hospital of Gannan Medical UniversityRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • Sun Yat-Sen Memorial Hospital Sun Yat-sen UniversityRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • The Second Affiliated Hospital of Zhejiang University College of MedicineRecruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
  • Harbin medical university cancer hospitalRecruiting
  • Huizhou Municipal Central HospitalRecruiting
  • Huizhou First HospitalRecruiting
  • Liuzhou people's HospitalRecruiting
  • Affiliated Hospital of North Sichuan Medical CollegeRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Shenzhen People's HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Shenzhen university General HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Union Hospital Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Xiangyang Central HospitalRecruiting
  • Yantai Yuhuangding HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • CHU GrenobleRecruiting
  • Institute Coeur PoumonRecruiting
  • CHU de Limoges, Hopital DupuytrenRecruiting
  • Hopital NordRecruiting
  • Evangelische Lungenklinik BerlinRecruiting
  • Niels-Stensen-Kliniken Franziskus-Hospital HarderbergRecruiting
  • Universitaetsklinikum Giessen und Marburg GmbHRecruiting
  • Munster University HospitalRecruiting
  • Oncologianova GmbHRecruiting
  • Onkologische Schwerpunktpraxis
  • Rambam Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Meir Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Chaim Sheba Medical CenterRecruiting
  • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo IIRecruiting
  • A.O.U Sant'Orsola-MalpighiRecruiting
  • European Institute of OncologyRecruiting
  • Aou San Luigi GonzagaRecruiting
  • Istituto Oncologico Veneto - IRCCSRecruiting
  • Ospedale S. Maria Delle CrociRecruiting
  • A.O. San Camillo ForlaniniRecruiting
  • Istituto Nazionale Tumori Regina ElenaRecruiting
  • Istituto Clinico HumanitasRecruiting
  • National Cancer Center HospitalRecruiting
  • National Hospital Organization Himeji Medical CenterRecruiting
  • Kansai Medical University HospitalRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Kurashiki Central HospitalRecruiting
  • Kurume University HospitalRecruiting
  • Matsusaka Municipal HospitalRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Osaka International Cancer InstituteRecruiting
  • Hokkaido University HospitalRecruiting
  • Shizuoka Cancer CenterRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting
  • Fujita Health University HospitalRecruiting
  • National Hospital Organization Osaka Toneyama Medical CenterRecruiting
  • Wakayama Medical University HospitalRecruiting
  • National Hospital Organization Iwakuni Clinical CenterRecruiting
  • National Hospital Organization Yamaguchi Ube Medical CenterRecruiting
  • National Cancer CenterRecruiting
  • CHA Bundang Medical Center, CHA UniversityRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • GyeongSang National University HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Prince Court Medical CentreRecruiting
  • Pantai Hospital Kuala LumpurRecruiting
  • University Malaya Medical CentreRecruiting
  • Hospital Umum SarawakRecruiting
  • Beacon Hospital Sdn. Bhd.Recruiting
  • Sunway Medical CentreRecruiting
  • Centrum Onkologii im. Prof. F. Lukaszczyka w BydgoszczyRecruiting
  • Krakowski Szpital Specjalityczny im. Jana Pawla IIRecruiting
  • Mazowieckie Centrum Leczenia Chorob PlucRecruiting
  • Private Specialist Hospitals - MedPoloniaRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
  • Hospital de BragaRecruiting
  • Hospital da Luz, SARecruiting
  • Hosp. Cuf DescobertasRecruiting
  • Hospital Pedro HispanoRecruiting
  • Hospital Teresa HerreraRecruiting
  • Hosp. Gral. Univ. de AlicanteRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. Quiron DexeusRecruiting
  • Hosp. Reina SofiaRecruiting
  • Hosp. Univ. Insular de Gran CanariaRecruiting
  • Hosp. Univ. Lucus AugustiRecruiting
  • Hosp. Gral. Univ. Gregorio MaranonRecruiting
  • Hosp. Univ. La PazRecruiting
  • Hosp. Univ. Pta. de Hierro MajadahondaRecruiting
  • Hosp. Regional Univ. de MalagaRecruiting
  • Hosp. Univ. Central de AsturiasRecruiting
  • Hosp. Univ. Son EspasesRecruiting
  • Hosp. Virgen Del RocioRecruiting
  • Hosp. Univ. I Politecni La FeRecruiting
  • Changhua Christian HospitalRecruiting
  • Chang Kung Memorial HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Chung Shan Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University Cancer CenterRecruiting
  • National Taiwan University HospitalRecruiting
  • Linkou Chang Gung Memorial HospitalRecruiting
  • Phramongkutklao Hospital and Medical CollegeRecruiting
  • Siriraj HospitalRecruiting
  • Chiang Mai UniversityRecruiting
  • Adana City HospitalRecruiting
  • Adana Baskent HospitalRecruiting
  • Memorial Ankara HastanesiRecruiting
  • Gazi University HospitalRecruiting
  • Ankara Bilkent City HospitalRecruiting
  • Trakya University Medical FacultyRecruiting
  • Istanbul University Cerrahpasa Medical FacultyRecruiting
  • Acıbadem Maslak HospitalRecruiting
  • Dokuz Eylul University Medical FacultyRecruiting
  • IEU Medical Point HospitalRecruiting
  • Medical Park Samsun HastanesiRecruiting
  • Birmingham Heartlands HospitalRecruiting
  • Imperial College HealthcareRecruiting
  • Newcastle Freeman HospitalRecruiting
  • Royal Marsden HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Lazertinib with Amivantamab SC-CF

Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion

Arm Description

Lazertinib 240 mg will be administered orally once daily. Participants will receive Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 milligrams (mg)/ 2240 mg depending on the body weight by manual injection.

Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion.

Outcomes

Primary Outcome Measures

For All Regions Other Than the European Union (EU): Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
For EU Only: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2
AUC(Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15, will be reported.

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05388669
Brief Title
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
Acronym
PALOMA-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
November 21, 2023 (Anticipated)
Study Completion Date
February 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Detailed Description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. Lazertinib is an oral, highly potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The study will include screening phase (up to 28 days), a treatment phase (from randomization until the end of treatment visit), and a follow-up phase (from end of treatment visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first). Safety will be assessed by physical examinations, vital signs, electrocardiograms, echocardiograms, ophthalmologic assessments, laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) monitoring, and concomitant medication use. The total duration of the study will be up to 1 year and 11 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Lazertinib with Amivantamab SC-CF
Arm Type
Experimental
Arm Description
Lazertinib 240 mg will be administered orally once daily. Participants will receive Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 milligrams (mg)/ 2240 mg depending on the body weight by manual injection.
Arm Title
Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
Arm Type
Experimental
Arm Description
Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion.
Intervention Type
Drug
Intervention Name(s)
Lazertinib
Other Intervention Name(s)
JNJ-73841937, YH25448
Intervention Description
Lazertinib tablets will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Other Intervention Name(s)
JNJ-61186372
Intervention Description
Amivantamab injection will be administered subcutaneously by manual injection
Intervention Type
Drug
Intervention Name(s)
Amivantamab Intravenous
Other Intervention Name(s)
JNJ-61186372
Intervention Description
Amivantamab will be administered by IV infusion
Primary Outcome Measure Information:
Title
For All Regions Other Than the European Union (EU): Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Description
Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
Time Frame
Cycle 4 Day 1 (28 days cycle)
Title
For EU Only: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
Description
Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
Time Frame
Cycle 2 Day 1 (28 days cycle)
Title
Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2
Description
AUC(Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15, will be reported.
Time Frame
Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1).
Time Frame
Up to 1 year 11 months
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.
Time Frame
Up to 1 year 11 months
Title
Duration of Response (DOR)
Description
The DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR.
Time Frame
Up to 1 year 11 months
Title
Time to Response (TTR)
Description
Time to response (that is time to first response) is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, as defined by BICR using RECIST version 1.1., for participants who have PR or CR as their best response.
Time Frame
Up to 1 year 11 months
Title
Number of Participants With Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention.
Time Frame
Up to 1 year 11 months
Title
Number of Participants with AEs by Severity
Description
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time Frame
Up to 1 year 11 months
Title
Number of Participants with Clinical Laboratory Abnormalities
Description
Number of participants with clinical laboratory abnormalities (serum Chemistry, hematology, coagulation and urinalysis) will be reported.
Time Frame
Up to 1 year 11 months
Title
Number of Participants with Clinical Laboratory Abnormalities by Severity
Description
Number of participants with clinical laboratory abnormalities by severity (serum Chemistry, hematology, coagulation and urinalysis) will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time Frame
Up to 1 year 11 months
Title
Number of Participants Infusion Related Reactions (IRRs)
Description
Number of participants with IRRs will be reported.
Time Frame
Up to 1 year 11 months
Title
Number of Participants with Infusion Related Reactions (IRRs) by Severity
Description
Number of participants with IRRs by severity will be reported.
Time Frame
Up to 1 year 11 months
Title
For Regions Other Than EU: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
Description
The Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
Time Frame
Cycle 2 Day 1 (28 days cycle)
Title
For EU Only: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Description
The Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
Time Frame
Cycle 4 Day 1 (28 days cycle)
Title
Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4
Description
Model-predicted AUC(Day 1-15) defined as area under the concentration time curve from Cycle 4 Day 1 to Day 15, will be reported.
Time Frame
From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)
Title
Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
Description
Percentage of participants with presence of anti-amivantamab antibody anti-rHuPH20 antibodies will be reported.
Time Frame
Up to 1 year 11 months
Title
Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
Description
Percentage of participants with cancer therapy satisfaction in will be assessed using the modified TASQ. The modified TASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.
Time Frame
Up to 1 year 11 months
Title
Change from Baseline in TASQ as Assessed Over Time
Description
Change from baseline in TASQ as assessed Over time will be reported. The modified TASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.
Time Frame
Up to 1 year 11 months
Title
Participant Chair Time
Description
Participant chair time will be assessed by time and motion analysis.
Time Frame
Up to 1 year 11 months
Title
Duration of Treatment Administration
Description
Duration of treatment administration will be assessed by time and motion analysis.
Time Frame
Up to 1 year 11 months
Title
Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring
Description
Active health care professional time for drug preparation, treatment administration, and posttreatment monitoring will be assessed by time and motion analysis.
Time Frame
Up to 1 year 11 months
Title
Participant Time in Treatment Room
Description
Participant time in treatment room will be assessed by time and motion analysis.
Time Frame
Up to 1 year 11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started [US]) or an accredited local laboratory (sites outside of the US) Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1 Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement) Exclusion Criteria: Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization Participant has symptomatic or progressive brain metastases Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation Participant has uncontrolled tumor-related pain Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Duarte
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope Orange County Lennar Foundation Cancer Center
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope Long Beach Elm
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Individual Site Status
Recruiting
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Oncology and Hematology Care Clinic - Westside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Individual Site Status
Recruiting
Facility Name
IADT Instituto Argentino de Diagnostico y Tratamiento
City
Caba
ZIP/Postal Code
C1122
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncológico Korben
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clínica Viedma
City
Viedma
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cancer Research SA
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God Hospital Murdoch
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Cetus Oncologia
City
Belo Horizonte
ZIP/Postal Code
30110-017
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Cionc de Ensino e Pesquisa S/S
City
Curitiba
ZIP/Postal Code
80810-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ynova Pesquisa Clinica
City
Florianopolis
ZIP/Postal Code
88020-210
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Sao Francisco Xavier HMC Unidade de Oncologia
City
Ipatinga
ZIP/Postal Code
35162 189
Country
Brazil
Individual Site Status
Recruiting
Facility Name
UPCO Unidade de Pesquisa Clinica em Oncologia
City
Pelotas
ZIP/Postal Code
96020 080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Impar Servicos Hospitalares S/A
City
Rio de Janeiro
ZIP/Postal Code
22061-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncoclínicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
Rio de Janeiro
ZIP/Postal Code
22281-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Nucleo de Oncologia da Bahia
City
Salvador
ZIP/Postal Code
40170-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Impar Servicos Hospitalares SA - Hospital Nove de Julho
City
Sao Paulo
ZIP/Postal Code
01409-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Núcleo de Pesquisa São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Onco Star SP Oncologia Ltda
City
São Paulo
ZIP/Postal Code
04543-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beijing Shijitan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Chest hospital, Capital medical university
City
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
200240
Country
China
Individual Site Status
Recruiting
Facility Name
Jilin cancer hospital
City
Changchun
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital Of Changzhou
City
Changzhou
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610047
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
Southwest Hospital
City
ChongQing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
ZIP/Postal Code
341000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guang Zhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hang Zhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University College of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin medical university cancer hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Name
Huizhou First Hospital
City
Huizhou
ZIP/Postal Code
516003
Country
China
Individual Site Status
Recruiting
Facility Name
Liuzhou people's Hospital
City
Liuzhou
ZIP/Postal Code
545026
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
ZIP/Postal Code
637100
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen People's Hospital
City
Shen Zhen Shi
ZIP/Postal Code
518001
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen university General Hospital
City
Shenzhen
ZIP/Postal Code
518055
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangyang Central Hospital
City
Xiangyang
ZIP/Postal Code
441021
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
CHU Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Institute Coeur Poumon
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Limoges, Hopital Dupuytren
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Nord
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
City
Georgsmarienhütte
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Name
Munster University Hospital
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Oncologianova GmbH
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Individual Site Status
Recruiting
Facility Name
Onkologische Schwerpunktpraxis
City
Weinsberg
ZIP/Postal Code
74189
Country
Germany
Individual Site Status
Completed
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aou San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Oncologico Veneto - IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale S. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. San Camillo Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuo-Ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Himeji Medical Center
City
Himeji
ZIP/Postal Code
670-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurashiki Central Hospital
City
Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsusaka Municipal Hospital
City
Matsusaka
ZIP/Postal Code
515-8544
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Osaka Toneyama Medical Center
City
Toyonaka-shi
ZIP/Postal Code
560-8552
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Iwakuni Clinical Center
City
Yamaguchi
ZIP/Postal Code
740-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Yamaguchi Ube Medical Center
City
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
CHA Bundang Medical Center, CHA University
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
GyeongSang National University Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Prince Court Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pantai Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Umum Sarawak
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Beacon Hospital Sdn. Bhd.
City
Petaling Jaya
ZIP/Postal Code
46050
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Sunway Medical Centre
City
Petaling Jaya
ZIP/Postal Code
47500
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowski Szpital Specjalityczny im. Jana Pawla II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Private Specialist Hospitals - MedPolonia
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital da Luz, SA
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hosp. Cuf Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Pedro Hispano
City
Senhora da Hora,
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Teresa Herrera
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Gral. Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Quiron Dexeus
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Insular de Gran Canaria
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Pta. de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Regional Univ. de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Kung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Cancer Center
City
Taipei City
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33382
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Phramongkutklao Hospital and Medical College
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Chiang Mai University
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Adana City Hospital
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Adana Baskent Hospital
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Hospital
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Acıbadem Maslak Hospital
City
Istanbul
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
IEU Medical Point Hospital
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medical Park Samsun Hastanesi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newcastle Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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