Clinical trial • Phase III • Oncology

AMIVANTAMAB for EGFR-mutated non-small cell lung cancer|Locally advanced or metastatic non-small cell lung cancer

Phase III trial of AMIVANTAMAB for EGFR-mutated non-small cell lung cancer|Locally advanced or metastatic non-small cell lung cancer.

Overview

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

Key dates

Initial CTIS Submission Date
19-12-2023
First CTIS Authorization Date
07-02-2024

Trial design

Randomised, open-label, carboplatin + pemetrexed (platinum-based chemotherapy) (comparator arm: carboplatin and pemetrexed); dosing and schedule not specified in the ctis summary.-controlled Phase III trial across 51 sites in Czechia, Denmark, Portugal and others.

Randomised
Yes
Open Label
Yes
Comparator
Carboplatin + Pemetrexed (platinum-based chemotherapy) (comparator arm: carboplatin and pemetrexed); dosing and schedule not specified in the CTIS summary.
Target Sample Size
517

Eligibility

Recruits 517 The record indicates vulnerable populations were selected. Participants must be adults (≥18 years or legal age of consent in the jurisdiction) and must sign a written informed consent form (ICF). Country-specific ICFs and related subject information documents are provided (multiple country-language versions present). No specific procedures for assent of minors are provided in the available record; consent is handled via the ICF and legal-age/representative requirements as per local law..

Pregnancy Exclusion
10. A participant 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.
Vulnerable Population
The record indicates vulnerable populations were selected. Participants must be adults (≥18 years or legal age of consent in the jurisdiction) and must sign a written informed consent form (ICF). Country-specific ICFs and related subject information documents are provided (multiple country-language versions present). No specific procedures for assent of minors are provided in the available record; consent is handled via the ICF and legal-age/representative requirements as per local law.

Inclusion criteria

  • {"criterion_text":"- 1. At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).\n- 7. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, erythropoietin stimulating agents, or platelet-boosting treatments within 7 days prior to the date of the laboratory test: • Hemoglobin ≥10 g/dL • Absolute neutrophil count ≥1.5×10^9/L, without use of G-CSF within 10 days prior to the date of the test • Platelets ≥100×10^9/L • ALT and AST ≤3×upper limit of normal (ULN) • Total bilirubin ≤1.5×ULN if no liver metastasis, or ≤3×ULN in the presence of liver metastasis (participants with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits) • Creatinine clearance >50 mL/min as measured or calculated by Cockcroft-Gault formula\n- 8. Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade ≤2 peripheral neuropathy, or Grade ≤2 hypothyroidism stable on hormone replacement).\n- 9. Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n- 13. A participant 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 participant who is sexually active with a participant of childbearing potential must agree to use a condom and the partner must also be practicing a highly effective method of contraception. A participant who is vasectomized must still use a condom for prevention of passage of exposure through ejaculation, but the participant’s partner is not required to use contraception.\n- 14. A 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. Participants should be advised to consider preservation of sperm prior to treatment with pemetrexed or carboplatin, as these agents may impair fertility.\n- 15. Participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n- 10. A participant 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- 11. A participant must be either of the following: a. Not of childbearing potential; or b. Of childbearing potential and • practicing true abstinence during the entire period of the study, including up to 7 months after the last dose of study treatment is given; or • have a sole partner who is vasectomized; or • practicing at least 1 highly effective user independent method of contraception. Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.\n- 12. A participant 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- 2. Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous NSCLC, characterized at or after the time of locally advanced metastatic disease diagnosis by either EGFR Exon 19del or Exon 21 L858R mutation, by an FDA-approved or other validated test of either ctDNA or tumor tissue in a CLIA certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US). A de-identified copy of the initial test report documenting the EGFR mutation must be included in the participant records and must be submitted to the sponsor during the Screening Phase. If provision of this report is not permitted by the site or local policies, then sponsor-approved equivalent documentation must be provided.\n- 3. Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first line treatment for locally advanced or metastatic disease or in the second line setting after prior treatment with first- or second-generation EGFR TKI as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 halflives) prior to randomization (ie, last dose no later than Day -8).\n- 4. 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 the optional 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- 5. Participants with a history of brain metastases must have had all lesions treated as clinically indicated (ie, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than 10 mg rednisone or equivalent daily for the treatment of intracranial disease.\n- 6. Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1."}

Exclusion criteria

  • {"criterion_text":"- 1. Participant has an uncontrolled illness, including but not limited to: • Uncontrolled diabetes • Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics at least 1 week prior to starting study treatment] or diagnosed or suspected viral infection), except as allowed by Exclusion Criterion 17 for HIV • Active bleeding diathesis • Impaired oxygenation requiring continuous oxygen supplementation • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of study treatment • Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements • Any ophthalmologic condition that is clinically unstable\n- 10. Participant has a history of hypersensitivity to carboplatin or pemetrexed, or to any excipient of carboplatin, pemetrexed, amivantamab, or lazertinib.\n- 11. Participant has an active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Exceptions include participants who have undergone curative therapy and have no evidence of disease recurrence since completion of that therapy, and those with local cancers that have been apparently cured such as: a. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured. b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. c. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured. d. Localized prostate cancer (N0M0): • with a Gleason score of 6, treated within the last 24 months or untreated and under surveillance, • with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, • or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence. e. Breast cancer: • lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. f. Other malignancy that is considered cured with minimal risk of recurrence.\n- 12. Participant has any contraindication to treatment with pemetrexed or carboplatin or participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid.\n- 2. Participant received prior systemic anticancer therapy in the locally advanced or metastatic setting, or in the adjuvant setting, for the same nonsquamous NSCLC intended for treatment now, except as allowed by Inclusion Criterion 3.\n- 3. Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization.\n- 4. Participants with symptomatic or progressive brain metastases.\n- 5. Participant previously enrolled in the Sponsor's study 73841937NSC3003 (NCT04487080).\n- 6. Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.\n- 7. Participant has known small cell transformation.\n- 8. Participant has uncontrolled tumor-related pain. Symptomatic lesions amenable to palliative radiotherapy (eg, bone metastases, or metastases causing nerve impingement) should be treated at least 14 days prior to randomization.\n- 9. Participant has a medical history of ILD, including drug induced ILD or radiation pneumonitis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Progression-free survival (PFS) using RECIST v1.1 guidelines, as assessed by blinded independent central review (BICR).","definition_or_measurement_approach":"PFS measured using RECIST v1.1 and assessed by blinded independent central review (BICR)."}

Recruitment

Planned Sample Size
517
Recruitment Window Months
55
Consent Approach
Written informed consent required. 'Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.' Country-specific subject information sheets and ICFs are provided (multiple languages and country-specific addenda present). No assent procedures for minors are provided (study enrols adults or legal-age participants).

Geography

Total Number Of Sites
51
Total Number Of Participants
259

Czechia

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
300
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Plicni oddeleni
Contact Person Name
Jaromir Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz

Denmark

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
07-02-2024
Processing Time Days
385
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Rigshospitalet
Department Name
Klinisk Forskningsenhed, Afdelingen for Kræftbehandling
Contact Person Name
Jens Benn Sorensen
Contact Person Email
Jens.Benn.Soerensen@regionh.dk

Portugal

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
22-11-2024
Processing Time Days
259
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
António Araújo
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Not Applicable
Contact Person Name
Sara Alves
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
Not Applicable
Contact Person Name
Direndra Hasmucrai
Contact Person Email
direndra@chln.min-saude.pt
Site Name
Hospital Beatriz Angelo
Department Name
Serviço de Oncologia
Contact Person Name
João Moreira Pinto
Contact Person Email
joao.ppinto@hbeatrizangelo.pt

Netherlands

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
748
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Ziekenhuis St Jansdal
Department Name
Pneumology
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Lung oncology
Contact Person Name
Anne-Marie Dingemans
Contact Person Email
a.dingemans@erasmusmc.nl
Site Name
Amsterdam UMC
Department Name
Lung oncology
Contact Person Name
Sayed Hashemi
Contact Person Email
s.hashemi@amsterdamumc.nl

Belgium

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
766
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Lung Oncology
Contact Person Name
Veerle Surmont
Contact Person Email
veerle.surmont@uzgent.be
Site Name
Jessa Ziekenhuis
Department Name
Pneumologie - Thoracal oncology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Grand Hopital De Charleroi
Department Name
Lung Oncology
Contact Person Name
Benoit Colinet
Contact Person Email
be.colinet@ghdc.be
Site Name
UZ Leuven
Department Name
Lung Oncology
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Lung Oncology
Contact Person Name
Anne Sibille
Contact Person Email
anne.sibille@chu.ulg.ac.be
Site Name
Antwerp University Hospital
Department Name
Lung Oncology
Contact Person Name
Jo Raskin
Contact Person Email
Jo.Raskin@uza.be

Bulgaria

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
447
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
UMHAT Sofiamed OOD
Department Name
Department of Medical Oncology
Contact Person Name
Velko Minchev
Contact Person Email
v_minchev@abv.bg

Germany

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
453
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Polikinik für Innere Medizin II
Contact Person Name
Christian Schulz
Contact Person Email
christian.schulz@ukr.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Department of pulmonary medicine and thoracic oncology
Contact Person Name
Claas Wesseler
Contact Person Email
c.wesseler@asklepios.com
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Studienzentrum Thoraxonkologie
Contact Person Name
Farastuk Bozorgmehr

Spain

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
766
Number Of Sites
11
Number Of Participants
72

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology Medicine
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazares@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology Medicine
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology Medicine
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology Medicine
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology Medicine
Contact Person Name
Oscar José Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology Medicine
Contact Person Name
Manuel Domine Gómez
Contact Person Email
MDomine@fjd.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Medicine
Contact Person Name
Reyes Bernabé Caro
Contact Person Email
reyesbernab@yahoo.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology Medicine
Contact Person Name
Maria del Rosario Garcia Campelo
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology Medicine
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology Medicine
Contact Person Name
Gema Maria Garcia Ledo
Contact Person Email
gmgarcialedo@hmhospitales.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncology Medicine
Contact Person Name
Miguel Fernández de Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es

Italy

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
567
Number Of Sites
5
Number Of Participants
58

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
SSD Patologia Toracica
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Dipartimento di Oncologia Toracica
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UO di Oncologia
Contact Person Name
Manolo D’Arcangelo
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.gov.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica e dei Tumori Correlati
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it

Sweden

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
748
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Uppsala University Hospital
Department Name
KFUE, Blod- och Tumörsjukdomar
Contact Person Name
George Holgersson
Contact Person Email
georg.holgersson@akademiska.se

Poland

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
447
Number Of Sites
5
Number Of Participants
21

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
KLINIKA NOWOTWOROW PLUCA I KLATKI PIERSIOWEJ
Contact Person Name
Dariusz Kowalski
Contact Person Email
Dariusz.Kowalski@nio.gov.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Anna Kowalczyk
Contact Person Email
akow@gumed.edu.pl
Site Name
Med Polonia Sp. z o.o.
Department Name
Not Applicable
Contact Person Name
Rodryg Ramlau
Contact Person Email
rramlau@gmail.com

France

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
748
Number Of Sites
10
Number Of Participants
48

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Respiratory diseases department
Contact Person Name
Remi VEILLON
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology medical department
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Oncology department
Contact Person Name
Pascale TOMASINI
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Pneumology department
Contact Person Name
Herve LENA
Contact Person Email
herve.lena@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Respiratory diseases department
Contact Person Name
Benoit ROCH
Contact Person Email
b-roch@chu-montpellier.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology department
Contact Person Name
Celine MASCAUX
Site Name
Centre Hospitalier Le Mans
Department Name
Pneumology department
Contact Person Name
Olivier MOLINIER
Contact Person Email
omolinier@ch-lemans.fr
Site Name
Hospices Civils De Lyon
Department Name
Pneumologie department
Contact Person Name
Michael DURUISSEAUX
Site Name
Institut Curie
Department Name
Thoracic oncology
Contact Person Name
Nicolas GIRARD
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pneumology and thoracic oncology
Contact Person Name
Alexis CORTOT
Contact Person Email
alexis.cortot@chru-lille.fr

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"Pharmacokinetics","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, Histopathology, exploratory, ctDNA, biomarkers, pk, immunogenicity, optional tumor tissue sample","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"exploratory biomarker analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IWRS","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"Clinical microbiology, ctDNA","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"IHC","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"CT, MRI, Brain MRI","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Exco Intouch Limited","duties_or_roles":"ePRO for XML","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"exploratory, ctDNA, biomarkers, pk, optional tumor tissue sample, Clinical microbiology","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Routine clinical pathology testing, Histopathology, exploratory, ctDNA, biomarkers, pk, immunogenicity, optional tumor tissue sample","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"Pharmacokinetics","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"China","full_name":"Frontage Laboratories (Shanghai) Co. Ltd.","duties_or_roles":"Pharmacokinetics","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-61186372
Active Substance
AMIVANTAMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
JNJ-73841937
Active Substance
LAZERTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Investigational Product Name
Pemetrexed Seacross 500 mg powder for concentrate for solution for infusion
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorisation in IE (PA22766/002/002) indicated in record
Maximum Dose
500 mg/m2
Investigational Product Name
Carboplatin 10 mg/ml Intravenous Infusion
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorisation information present for commercial products in record
Maximum Dose
750 mg
Combination Treatment
Yes

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