Clinical trial • Phase III • Oncology
AMIVANTAMAB for Non-small cell lung cancer (EGFR-mutated, advanced or metastatic)
Phase III trial of AMIVANTAMAB for Non-small cell lung cancer (EGFR-mutated, advanced or metastatic).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (EGFR-mutated, advanced or metastatic)
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 29-05-2024
- First CTIS Authorization Date
- 19-07-2024
Trial design
Randomised, open-label, intravenous amivantamab (jnj-61186372) — comparator arm described as amivantamab iv; dose and schedule not specified in the provided record.-controlled Phase III trial in Portugal, Poland, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Intravenous Amivantamab (JNJ-61186372) — comparator arm described as amivantamab IV; dose and schedule not specified in the provided record.
- Target Sample Size
- 342
Eligibility
Recruits 342 No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent provided by participants (adult population). Subject information and informed consent forms are provided (multiple country versions); no assent or paediatric/parental consent procedures are described in the available documents..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent provided by participants (adult population). Subject information and informed consent forms are provided (multiple country versions); no assent or paediatric/parental consent procedures are described in the available documents.
Inclusion criteria
- {"criterion_text":"- 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)\n- 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\n- Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1\n- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1\n- 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
- {"criterion_text":"- Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors\n- Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization\n- Participant has symptomatic or progressive brain metastases\n- Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation\n- Participant has uncontrolled tumor-related pain\n- Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Ctrough of amivantamab: at steady state (Cycle 4 Day 1) for all regions other than EU and others accepting Cycle 2 Day 1 and pre-dose on Cycle 2 Day 1 for EU and any other applicable region","definition_or_measurement_approach":"Ctrough of amivantamab measured at steady state (Cycle 4 Day 1) for most regions; for EU and regions accepting Cycle 2 Day 1 measured pre-dose on Cycle 2 Day 1 (measurement timing specified in endpoint text)."}
- {"endpoint_text":"- AUCD1-D15 in Cycle 2","definition_or_measurement_approach":"AUCD1-D15 measured in Cycle 2 (as stated in endpoint text)."}
Recruitment
- Planned Sample Size
- 342
- Recruitment Window Months
- 57
- Consent Approach
- Informed consent obtained from participants (adult population). Subject information and informed consent forms are available in multiple country versions and languages (documents include master and country-specific ICFs and related forms for Portugal, Poland, Italy, Spain, France and Germany). Specific assent/parental consent procedures for minors are not described.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 76
Portugal
- Latest Decision Or Authorization Date
- 08-11-2024
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Matosinhos E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Fernanda Estevinho
- Principal Investigator Email
- fernandaestevinho@gmail.com
- Contact Person Name
- Fernanda Estevinho
- Contact Person Email
- fernandaestevinho@gmail.com
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Encarnacao Teixeira
- Principal Investigator Email
- encarnacaoteixeira@gmail.com
- Contact Person Name
- Encarnacao Teixeira
- Contact Person Email
- encarnacaoteixeira@gmail.com
Poland
- Latest Decision Or Authorization Date
- 27-03-2026
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Pluca i Klatki Piersiowej
- Principal Investigator Name
- Dariusz Kowalski
- Principal Investigator Email
- dariusz.kowalski@nio.gov.pl
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- dariusz.kowalski@nio.gov.pl
Italy
- Latest Decision Or Authorization Date
- 27-03-2026
- Number Of Sites
- 1
- Number Of Participants
- 27
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncologia Toracica
- Principal Investigator Name
- Antonio Passaro
- Principal Investigator Email
- antonio.passaro@ieo.it
- Contact Person Name
- Antonio Passaro
- Contact Person Email
- antonio.passaro@ieo.it
Spain
- Latest Decision Or Authorization Date
- 25-03-2026
- Number Of Sites
- 2
- Number Of Participants
- 29
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- Maria del Rosario Garcia Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria del Rosario Garcia Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Principal Investigator Name
- Javier De Castro
- Principal Investigator Email
- javier.decastro@salud.madrid.org
- Contact Person Name
- Javier De Castro
- Contact Person Email
- javier.decastro@salud.madrid.org
France
- Latest Decision Or Authorization Date
- 24-03-2026
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Oncology Department
- Principal Investigator Name
- Alexis CORTOT
- Principal Investigator Email
- alexis.cortot@chru-lille.fr
- Contact Person Name
- Alexis CORTOT
- Contact Person Email
- alexis.cortot@chru-lille.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncology Department
- Principal Investigator Name
- Laurent GREILLIER
- Principal Investigator Email
- laurent.greillier@ap-hm.fr
- Contact Person Name
- Laurent GREILLIER
- Contact Person Email
- laurent.greillier@ap-hm.fr
Germany
- Latest Decision Or Authorization Date
- 30-03-2026
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Medizinische Klinik IV und V
- Principal Investigator Name
- Thomas Wehler
- Principal Investigator Email
- Thomas.Wehler@innere.med.uni-giessen.de
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- Thomas.Wehler@innere.med.uni-giessen.de
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International Corp.
- Name
- Almac Clinical Technologies LLC
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sample management","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Frontage Laboratories Suzhou Co. Ltd.","duties_or_roles":"PK Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"PK Analysis and Immunogenicity","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Covance Bioanalytical Services LLC","duties_or_roles":"Immunogenicity","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sample management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"PRO","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"PK Analysis and Immunogenicity","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- JNJ-61186372
- Active Substance
- AMIVANTAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Intravenous use | Subcutaneous use
- Authorisation Status
- Authorised
- Investigational Product Name
- JNJ-73841937
- Active Substance
- LAZERTINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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