Clinical trial • Phase III • Oncology

AMIVANTAMAB for Non-small cell lung cancer | EGFR-mutated non-small cell lung cancer

Phase III trial of AMIVANTAMAB for Non-small cell lung cancer | EGFR-mutated non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | EGFR-mutated non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody | Small molecule

Key dates

Initial CTIS Submission Date
27-03-2024
First CTIS Authorization Date
12-06-2024

Trial design

Randomised, osimertinib (tagrisso) 40 mg or 80 mg oral film-coated tablets (oral use) as comparator; lazertinib (jnj-73841937) oral tablet as comparator (dose/schedule not specified in the provided record).-controlled Phase III trial in Belgium, France, Italy and others.

Randomised
Yes
Comparator
Osimertinib (TAGRISSO) 40 mg or 80 mg oral film-coated tablets (oral use) as comparator; Lazertinib (JNJ-73841937) oral tablet as comparator (dose/schedule not specified in the provided record).
Target Sample Size
904

Eligibility

Recruits 904 The protocol states: 'Participant must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.' The protocol allows consent to be provided by a legally acceptable representative where applicable; country-specific ICFs and addenda are provided..

Pregnancy Exclusion
Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
Vulnerable Population
The protocol states: 'Participant must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.' The protocol allows consent to be provided by a legally acceptable representative where applicable; country-specific ICFs and addenda are provided.

Inclusion criteria

  • {"criterion_text":"- Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).\n- A woman of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.\n- A woman must be (as defined in Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information) either of the following: a. Not of childbearing potential b. Of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given c. Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method (examples of highly effective methods of contraception are located in Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information). Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment. Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin birth control, as described above.\n- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.\n- A man must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A man who is sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (ie, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]). If the participant is vasectomized, he must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but his female partner is not required to use contraception.\n- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.\n- Participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n- Participant must have newly diagnosed, histologically or cytologically confirmed, locally advanced or metastatic NSCLC that is treatment naïve and not amenable to curative therapy including surgical resection or chemoradiation.\n- The tumor (meeting criteria described in Inclusion Criterion no. 2) harbors Exon 19del or Exon 21 L858R substitution, as detected by an FDA-approved or other validated test in a CLIA certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. (Note: A copy of the test report documenting the EGFR mutation must be included in the participant records and must also be submitted to the sponsor.)\n- Mandatory submission of unstained tissue from tumor meeting criteria described in Inclusion Criterion no. 2 (in a quantity sufficient to allow for central analysis of EGFR mutation status) and blood (for ctDNA, digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis).\n- Any toxicities from prior anticancer therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline level.\n- Participant must have at least 1 measurable lesion, according to RECIST v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 nonirradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy.\n- Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or granulocyte colony-stimulating factor (G-CSF) within 7 days prior to the date of the test.\n- Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n- Participant must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study."}

Exclusion criteria

  • {"criterion_text":"- Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease).\n- Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib.\n- Participant is currently receiving medications or herbal supplements known to be potent CYP3A4/5 inducers and is unable to stop use for an appropriate washout period prior to randomization\n- Participant has received any prior treatment with an EGFR TKI.\n- Participant has received an investigational medication within 12 months before randomization or is currently enrolled in an investigational study.\n- Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.\n- Participant plans to father a child while enrolled in this study or within 6 months after the last dose of study treatment.\n- Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n- Participant has at Screening: • Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) • Positive hepatitis C (hepatitis C virus [HCV]) antibody (anti-HCV) • Other clinically active infectious liver disease\n- Participant is positive for human immunodeficiency virus (HIV)\n- Participant had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 4 weeks before randomization, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.\n- 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 randomization are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (≤10 mg/day prednisone or equivalent) for at least 2 weeks prior to randomization.\n- Participant has an active or past medical history of leptomeningeal disease.\n- Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment ≤10 mg/day prednisone or equivalent.\n- Participant has uncontrolled tumor-related pain.\n- Participant has an active or past medical history of ILD/pneumonitis, including drug-induced or radiation ILD/pneumonitis.\n- Participant has an uncontrolled illness\n- Participant has an active malignancy other than the disease being treated under study\n- Participant has active cardiovascular disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS according to RECIST v1.1 by blinded independent central review","definition_or_measurement_approach":"PFS assessed per RECIST v1.1 by a blinded independent central review."}

Other endpoints

  • {"endpoint_text":"- Tolerability, Immunogenicity, Quality of Life and Biomarker evaluation","definition_or_measurement_approach":"Tolerability assessed via safety and adverse event monitoring (CTCAE). Immunogenicity and biomarker evaluation include central EGFR mutation testing on tumor tissue, ctDNA (digital droplet PCR) and pharmacogenomic analyses; Quality of Life measured using patient-reported instruments (protocol includes ePRO tools such as PGIC, EQ-5D-5L, QLQ-C30, NSCLC-SAQ as per protocol documents)."}

Recruitment

Planned Sample Size
904
Recruitment Window Months
89
Consent Approach
Participant must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Country-specific informed consent documents and addenda are provided (examples in English, French, Dutch, German, Spanish, Polish, Portuguese, Italian, Hungarian as per submitted ICF documents).

Geography

Total Number Of Sites
45
Total Number Of Participants
170

Belgium

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
661
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
UZ Leuven
Department Name
Respiratoire Oncologie
Principal Investigator Name
Christophe Dooms
Principal Investigator Email
datanursingreo@uzleuven.be
Contact Person Name
Christophe Dooms
Contact Person Email
datanursingreo@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Longziekten
Principal Investigator Name
Ingel Demedts
Principal Investigator Email
secr.longziekten@azdelta.be
Contact Person Name
Ingel Demedts
Contact Person Email
secr.longziekten@azdelta.be
Site Name
Grand Hopital De Charleroi
Department Name
Pneumologie
Principal Investigator Name
Benoit Colinet
Principal Investigator Email
Benoit.COLINET2@ghdc.be
Contact Person Name
Benoit Colinet
Contact Person Email
Benoit.COLINET2@ghdc.be

France

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
662
Number Of Sites
6
Number Of Participants
29

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pneumologie
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
Institut Curie
Department Name
Oncologie médicale
Principal Investigator Name
Nicolas Girard
Principal Investigator Email
nicolas.girard@curie.fr
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard@curie.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumologie
Principal Investigator Name
Denis Moro-Sibilot
Principal Investigator Email
dmoro-sibilot@chu-grenoble.fr
Contact Person Name
Denis Moro-Sibilot
Contact Person Email
dmoro-sibilot@chu-grenoble.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Pneumologie - Cancérologie
Principal Investigator Name
Eric Pichon
Principal Investigator Email
e.pichon@chu-tours.fr
Contact Person Name
Eric Pichon
Contact Person Email
e.pichon@chu-tours.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncologie médicale
Principal Investigator Name
Pascale Tomasini
Principal Investigator Email
pascale.tomasini@ap-hm.fr
Contact Person Name
Pascale Tomasini
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Institut Bergonie
Department Name
Oncologie médicale
Principal Investigator Name
Sophie Cousin
Principal Investigator Email
s.cousin@bordeaux.unicancer.fr
Contact Person Name
Sophie Cousin
Contact Person Email
s.cousin@bordeaux.unicancer.fr

Italy

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
665
Number Of Sites
10
Number Of Participants
24

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.S.D. Oncologia Polmonare
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. di Oncologia
Principal Investigator Name
Manolo D’Arcangelo
Principal Investigator Email
manolo.darcangelo@auslromagna.it
Contact Person Name
Manolo D’Arcangelo
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia Medica ed Ematologia
Principal Investigator Name
Claudia Proto
Principal Investigator Email
Claudia.Proto@istitutotumori.mi.it
Contact Person Name
Claudia Proto
Site Name
Humanitas Research Hospital
Department Name
U.O. di Oncologia Medica ed Ematologia
Principal Investigator Name
Armando Santoro
Principal Investigator Email
armando.santoro@cancercenter.humanitas.it
Contact Person Name
Armando Santoro
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
S.S.D. Patologia Toracica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Hector Josè Soto Parra
Principal Investigator Email
hsotoparra@policlinico.unict.it
Contact Person Name
Hector Josè Soto Parra
Site Name
Azienda Ospedaliera Dei Colli
Department Name
U.O.C. di Pneumologia Oncologica
Principal Investigator Name
Danilo Rocco
Principal Investigator Email
danilorocc@yahoo.it
Contact Person Name
Danilo Rocco
Contact Person Email
danilorocc@yahoo.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Dipartimento di Oncologia Toracica
Principal Investigator Name
Filippo De Marinis
Principal Investigator Email
filippo.demarinis@ieo.it
Contact Person Name
Filippo De Marinis
Contact Person Email
filippo.demarinis@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Oncologia
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@policlinicogemelli.it
Contact Person Name
Emilio Bria

Spain

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
665
Number Of Sites
13
Number Of Participants
74

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Principal Investigator Name
Reyes Bernabé Caro
Principal Investigator Email
bernabeensayos@gmail.com
Contact Person Name
Reyes Bernabé Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Medical 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
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Principal Investigator Name
Francisco Javier De Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Francisco Javier De Castro Carpeño
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Luis Paz-Ares Rodriguez
Principal Investigator Email
lpazaresr@seom.org
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital General Universitario De Valencia
Department Name
Medical Oncology
Principal Investigator Name
Paula Espinosa Olarte
Principal Investigator Email
paula.espinosa.olarte@gmail.com
Contact Person Name
Paula Espinosa Olarte
Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology
Principal Investigator Name
Vanesa Gutierrez Calderon
Principal Investigator Email
vanesa_gutierrez78@hotmail.com
Contact Person Name
Vanesa Gutierrez Calderon
Contact Person Email
vanesa_gutierrez78@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Principal Investigator Name
Rosa Alvarez Alvarez
Principal Investigator Email
rosa.alvarez.al@gmail.com
Contact Person Name
Rosa Alvarez Alvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Medical Oncology
Principal Investigator Name
Andrés Aguilar
Principal Investigator Email
aaguilar@oncorosell.com
Contact Person Name
Andrés Aguilar
Contact Person Email
aaguilar@oncorosell.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Principal Investigator Name
Margarita Majem Tarruella
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Medical Oncology
Principal Investigator Name
Enric Carcereny Costa
Principal Investigator Email
ecarcereny@iconcologia.net
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Medical Oncology
Principal Investigator Name
Joaquim Bosch Barrera
Principal Investigator Email
jbosch@iconcologia.net
Contact Person Name
Joaquim Bosch Barrera
Contact Person Email
jbosch@iconcologia.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical Oncology
Principal Investigator Name
Mariano Provencio
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio

Poland

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
14-02-2026
Processing Time Days
665
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzial Onkologii z Pododdzialem Chemioterapii
Principal Investigator Name
Andrzej Kazarnowicz
Principal Investigator Email
andrzej_kazarnowicz@wp.pl
Contact Person Name
Andrzej Kazarnowicz
Contact Person Email
andrzej_kazarnowicz@wp.pl
Site Name
Med Polonia Sp. z o.o.
Department Name
NZOZ Med-Polonia Sp. z o.o.
Principal Investigator Name
Rodryg Ramlau
Principal Investigator Email
rodrygramlau@gmail.com
Contact Person Name
Rodryg Ramlau
Contact Person Email
rodrygramlau@gmail.com
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Zurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
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

Netherlands

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
26-11-2024
Processing Time Days
218
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Research Unit Longziekten
Principal Investigator Name
Michel van den Heuvel
Principal Investigator Email
researchunit.long@radboudumc.nl
Contact Person Name
Michel van den Heuvel
Site Name
Ziekenhuis St Jansdal
Department Name
Poli Longgeneeskunde
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
ln.boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl
Site Name
Jeroen Bosch Ziekenhuis
Department Name
Polikliniek Longziekten, Gebouw C, etage 1
Principal Investigator Name
Bonne Biesma
Principal Investigator Email
m.trialonclong@jbz.nl
Contact Person Name
Bonne Biesma
Contact Person Email
m.trialonclong@jbz.nl

Portugal

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
660
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Principal Investigator Name
Maria Cassiano Neves
Principal Investigator Email
maria.cassiano.neves@ipoporto.min-saude.pt
Contact Person Name
Maria Cassiano Neves

Hungary

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
662
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
I. Pulmonológiai Osztály
Principal Investigator Name
Zsolt Pápai-Székely
Principal Investigator Email
zsoltpapai@yahoo.com
Contact Person Name
Zsolt Pápai-Székely
Contact Person Email
zsoltpapai@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
660
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Westdeutsches Tumorzentrum, Innere Klinik
Principal Investigator Name
Martin Schuler
Principal Investigator Email
Martin.schuler@uk-essen.de
Contact Person Name
Martin Schuler
Contact Person Email
Martin.schuler@uk-essen.de
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Daniel Misch
Principal Investigator Email
daniel.misch@helios-gesundheit.de
Contact Person Name
Daniel Misch
Site Name
Robert-Bosch-Krankenhaus GmbH
Department Name
Abteilung fuer Pneumologische Onkologie
Principal Investigator Name
Martin Kimmich
Principal Investigator Email
martin.kimmich@rbk.de
Contact Person Name
Martin Kimmich
Contact Person Email
martin.kimmich@rbk.de
Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für Internistische Onkologie und Haematologie
Principal Investigator Name
Ekkehard Eigendorff
Principal Investigator Email
Ekkehard.Eigendorff@zentralklinik.de
Contact Person Name
Ekkehard Eigendorff

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
ECG analysis/ review; eCOA
Name
Labcorp Central Laboratory Services LP
Responsibilities
Central laboratory sample logistics for PK and biomarkers
Name
Smithers PDS LLC
Responsibilities
Pharmacokinetics
Name
Venn Life Sciences Ed B.V.
Responsibilities
PK analysis
Name
Bioclinica Inc.
Responsibilities
Imaging scan collect, hold , and read. ECHO/MUGA test collect, hold, read
Name
Guardant Health Inc.
Responsibilities
ctDNA testing
Name
Roche Sequencing Solutions Inc.
Responsibilities
test for tissue samples

Third parties

  • {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"Diagnostic","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Roche Sequencing Solutions Inc.","duties_or_roles":"test for tissue samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/ review","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"Pharmacokinetics","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory sample logistics for PK and biomarkers","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Venn Life Sciences Ed B.V.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging scan collect, hold , and read. ECHO/MUGA test collect, hold, read","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
JNJ-61186372
Active Substance
AMIVANTAMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
JNJ-73841937
Active Substance
LAZERTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Investigational Product Name
TAGRISSO 40 mg film-coated tablets
Active Substance
OSIMERTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
EU/1/16/1086/001
Starting Dose
40 mg
Dose Levels
40 mg
Investigational Product Name
TAGRISSO 80 mg film-coated tablets
Active Substance
OSIMERTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
EU/1/16/1086/002
Starting Dose
80 mg
Dose Levels
80 mg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.