Clinical trial • Phase III • Oncology

PATRITUMAB DERUXTECAN for Non-small cell lung cancer (EGFR-mutated)

Phase III trial of PATRITUMAB DERUXTECAN for Non-small cell lung cancer (EGFR-mutated).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (EGFR-mutated)
Trial Stage
Phase III
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
12-09-2024
First CTIS Authorization Date
08-10-2024

Trial design

Randomised, open-label, carboplatin (up to 750 mg iv), pemetrexed (500 mg/m2 iv), cisplatin (75 mg/m2 iv)-controlled Phase III trial in Poland, Netherlands, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
CARBOPLATIN (up to 750 mg IV), PEMETREXED (500 mg/m2 IV), CISPLATIN (75 mg/m2 IV)
Target Sample Size
403

Eligibility

Recruits 403 Vulnerable population selected. Consent requirements: "Sign and date the main ICF, prior to the start of any study-specific qualification procedures. Consent for the optional samples for EOT tumor biopsy and/or pharmacogenetic analysis will be covered in the main ICF." A separate consent for tissue screening is obtained. Participants must be aged ≥18 years so consent provided by the participant; no assent procedures for minors are described. Multiple language versions of participant information/ICF are provided (EN, DE, FR, ES, PT, IT, NL, PL, NO and regional/BE variants)..

Pregnancy Exclusion
Is a female who is pregnant or breastfeeding or intends to become pregnant during the study. For the full list of criteria, please see section 5.2 in protocol.
Vulnerable Population
Vulnerable population selected. Consent requirements: "Sign and date the main ICF, prior to the start of any study-specific qualification procedures. Consent for the optional samples for EOT tumor biopsy and/or pharmacogenetic analysis will be covered in the main ICF." A separate consent for tissue screening is obtained. Participants must be aged ≥18 years so consent provided by the participant; no assent procedures for minors are described. Multiple language versions of participant information/ICF are provided (EN, DE, FR, ES, PT, IT, NL, PL, NO and regional/BE variants).

Inclusion criteria

  • {"criterion_text":"- Sign and date the main ICF, prior to the start of any study-specific qualification procedures. Consent for the optional samples for EOT tumor biopsy and/or pharmacogenetic analysis will be covered in the main ICF.\n- Is willing to provide sufficient quantity and quality of tumor tissue content.\n- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.\n- Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to randomization as described in the protocol.\n- If the subject is a female of childbearing potential, must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control upon randomization, during the Treatment Period, and for 7 months following the last dose of patritumab deruxtecan. A female is considered to be of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) or if permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before randomization or confirmed by follicle stimulating hormone (FSH) test. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.\n- Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study Treatment Period and for at least 7 months after the final patritumab deruxtecan administration. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.\n- If male, must be surgically sterile or willing to use highly effective birth control upon randomization, during the Treatment Period, and for at least 4 months following the last dose of patritumab deruxtecan. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.\n- Male subjects must not freeze or donate sperm starting at Screening and throughout the study period and at least 4 months after the final patritumab deruxtecan administration. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country. For the full list of criteria, please see section 5.1 in protocol.\n- Is a male or female subject aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).\n- Has histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation.\n- Has documentation of an EGFR-activating mutation detected from tumor tissue or from a blood sample: exon 19 deletion or L858R at diagnosis or thereafter.\n- Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a thirdgeneration EGFR TKI (ie, approved therapies designed with higher preferential activity for mutant vs. EGFRwt and that address acquired resistance to first- and second-generation EGFR TKI [eg, osimertinib, lazertinib, aumolertinib, alflutinib, and others in consultation with Medical Monitor]). If a subject has received 2 prior lines of EGFR TKI therapy, administration of the third-generation EGFR TKI must have been in the most recent line. Subject must have documentation of T790M mutation if subjects had treatment with a first- or second-generation EGFR TKI prior to treatment with a third-generation EGFR TKI. Enrollment of subjects receiving third-generation EGFR TKIs other than osimertinib will be a maximum of approximately 20% of the enrolled population in each treatment arm.\n- May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting. a. To provide an example, a patient who received osimertinib as adjuvant therapy after tumor resection, then progressed to having metastatic disease over a year following completion of adjuvant therapy must have also received a third-generation EGFR TKI as treatment for metastatic disease to be considered eligible for this study.\n- Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI).\n- Has documentation of radiographic disease progression while receiving or after a third-generation EGFR TKI for metastatic or locally advanced disease.\n- Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment."}

Exclusion criteria

  • {"criterion_text":"- Has any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy, or squamous NSCLC histology.\n- Has history of other active malignancy within 3 years prior to randomization, except the following: a. Adequately resected nonmelanoma skin cancer. b. Adequately treated intraepithelial carcinoma of the cervix. c. Any other curatively treated in situ disease.\n- Has uncontrolled or significant cardiovascular disease prior to randomization as described in the protocol.\n- Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization.\n- Has a known HIV infection that is not well controlled. All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts/levels of >350 cells/μL, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the subject's viral RNA load and CD4+ cell count should be monitored per local SoC (e.g., every 3 months).\n- Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the Investigator's opinion, make it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility.\n- Has known hypersensitivity to either the drug substance or inactive ingredients in any of the drug products.\n- Is a female who is pregnant or breastfeeding or intends to become pregnant during the study. For the full list of criteria, please see section 5.2 in protocol.\n- Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during Screening.\n- Has clinically severe respiratory compromise (based on the Investigator's assessment) resulting from intercurrent pulmonary illnesses as described in the protocol.\n- Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization. Subjects who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n- Has any history of or evidence of current leptomeningeal disease.\n- Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic and untreated, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (i.e., without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study but must have a stable neurologic status for at least 2 weeks prior to randomization. Subjects with asymptomatic brain metastases and treated with anticonvulsants as prophylaxis are able to enroll\n- Has had inadequate washout period prior to randomization defined as follows: a. Whole-brain radiation therapy < 28 days or stereotactic brain radiation therapy <7 days. b. Major surgery (excluding placement of vascular access) <28 days. c. Radiotherapy treatment to >30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy < 7 days. d. Chloroquine or hydroxychloroquine ≤14 days. e. Live virus vaccination ≤28 days\n- Has had prior treatment with the following: a. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I. b. HER3 antibody. c. Any systemic therapies (other than EGFR TKIs) in the metastatic or locally advanced setting, including chemotherapy or any other systemic therapy in combination with an EGFR TKI.\n- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities [defined as no worsening to Grade >2 for at least 3 months prior to randomization and managed with SoC treatment]) that the Investigator deems related to previous anticancer therapy may be randomized."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free survival (PFS) as assessed by blinded independent central review (BICR) based on RECIST v1.1","definition_or_measurement_approach":"As assessed by blinded independent central review (BICR) based on RECIST v1.1"}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression-free survival (PFS) as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by the Investigator per RECIST v1.1"}
  • {"endpoint_text":"- Progression-free survival on the next line of therapy (PFS2) as assessed by local standard clinical practice","definition_or_measurement_approach":"Assessed by local standard clinical practice"}
  • {"endpoint_text":"- Objective response rate (ORR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by BICR and by Investigator per RECIST v1.1"}
  • {"endpoint_text":"- Duration of response (DoR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by BICR and by Investigator per RECIST v1.1"}
  • {"endpoint_text":"- Clinical benefit rate (CBR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by BICR and by Investigator per RECIST v1.1"}
  • {"endpoint_text":"- Disease control rate (DCR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by BICR and by Investigator per RECIST v1.1"}
  • {"endpoint_text":"- Time to response (TTR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by BICR and by Investigator per RECIST v1.1"}
  • {"endpoint_text":"- Patient-reported outcome (PRO) of disease-related symptoms, functioning scales, and general health status and overall quality of life","definition_or_measurement_approach":"PRO instruments (patient-reported outcomes) as specified in protocol (patient-facing documents available)"}
  • {"endpoint_text":"- Intracranial progression-free survival (PFS) as assessed by BICR per CNS—RECIST.","definition_or_measurement_approach":"Assessed by BICR using CNS-RECIST"}

Recruitment

Planned Sample Size
403
Recruitment Window Months
47
Consent Approach
Participants must sign and date the main ICF prior to study-specific qualification procedures. Consent is provided by the participant (age ≥18). Consent covers optional EOT tumor biopsy and pharmacogenetic analysis in the main ICF; a separate consent for tissue screening is obtained. Multiple language versions of participant information/ICF are provided (English, German, French, Spanish, Portuguese, Italian, Dutch, Polish, Norwegian and country-specific/BE variants).

Geography

Total Number Of Sites
48
Total Number Of Participants
183

Poland

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
587
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Med Polonia Sp. z o.o.
Contact Person Name
Rodryg Ramlau
Contact Person Email
rramlau@gmail.com
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Contact Person Name
Tomasz Jankowski
Contact Person Email
tjankowski.onkolog@wp.pl

Netherlands

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
834
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Department of Pulmonary Diseases
Contact Person Name
Egbert Smit
Contact Person Email
e.f.smit@lumc.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Pulmonology
Contact Person Name
Niels Claessens
Contact Person Email
nclaessens@rijnstate.nl
Site Name
Netherlands Cancer Institute
Department Name
Pulmonology
Contact Person Name
Joop De Langen
Contact Person Email
thoraxmanagement@nki.nl

Belgium

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
833
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Rachel Galot
Site Name
UZ Leuven
Department Name
Pulmonology
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pulmonology
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
A.Z. Sint-Maarten
Department Name
Pulmonology
Contact Person Name
Marc Lambrechts
Contact Person Email
marc.lambrechts@emmaus.be

Norway

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
832
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Cancer Genetics
Contact Person Name
Henrik Horndalsveen
Contact Person Email
b27864@ous-hf.no

Portugal

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
832
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Department Name
Serviço de pneumologia-oncológica
Contact Person Name
Margarida Dias
Site Name
Champalimaud Clinical Centre
Department Name
Unidade do pulmao
Contact Person Name
Marcos Pantarotto

Spain

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
833
Number Of Sites
11
Number Of Participants
33

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@hotmail.com
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
David Vicente Baz
Contact Person Email
dvicentebaz@yahoo.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Marta Lopez Brea
Contact Person Email
marta.lopezbrea@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Manuel Domine Gomez
Contact Person Email
mdomine@fjd.es
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
delvysra@yahoo.com
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@hospitaldelmar.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
nreguart@clinic.cat

France

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
836
Number Of Sites
10
Number Of Participants
46

Sites

Site Name
Centre Leon Berard
Department Name
Département d’oncologie médicale
Contact Person Name
Maurice Perol
Site Name
Institut Curie
Department Name
Service de pneumologie
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologie médicale
Contact Person Name
Xavier Quantin
Site Name
Centre Francois Baclesse
Department Name
Service oncologie médicale
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Contact Person Name
Judith Raimbourg
Site Name
Hospices Civils De Lyon
Department Name
Service de pneumologie
Contact Person Name
Sebastien Couraud
Contact Person Email
sebastien.couraud@chu-lyon.fr
Site Name
Institut Gustave Roussy
Department Name
Departement de medicine oncologique
Contact Person Name
Benjamin Besse
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncologie médicale
Contact Person Name
Judith Raimbourg
Site Name
Hospices Civils De Lyon (Croix Rousse)
Department Name
Service de pneumologie
Contact Person Name
Sebastien Couraud
Contact Person Email
sebastien.couraud@chu-lyon.fr
Site Name
Hospices Civils De Lyon (Bron)
Department Name
Service de pneumologie
Contact Person Name
Sebastien Couraud
Contact Person Email
sebastien.couraud@chu-lyon.fr

Germany

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
837
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Department Name
Thoraxonkologie
Contact Person Name
Akin Atmaca
Contact Person Email
atmaca.akin@khnw.de
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin
Contact Person Name
Christian Schumann
Site Name
Thoraxklinik Heidelberg gGmbH
Contact Person Name
Michael Thomas
Site Name
Asklepios Fachkliniken Muenchen Gauting
Department Name
Klinik für Pneumologie - Thorakale Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Lungenfachklinik Immenhausen
Contact Person Name
Achim Rittmeyer
Site Name
LungenClinic Grosshansdorf GmbH
Contact Person Name
Martin Reck
Contact Person Email
M.Reck@lungenclinic.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik - Tumorforschung
Contact Person Name
Marcel Wiesweg
Contact Person Email
marcel.wiesweg@uk-essen.de

Austria

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
837
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Abteilung für Innere Medizin und Pneumologie
Contact Person Name
Maximilian Hochmair
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Innere Medizin V Innsbruck
Contact Person Name
Andreas Pircher

Italy

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
830
Number Of Sites
6
Number Of Participants
43

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Dept. of Oncology
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica
Contact Person Name
Editta Baldini
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
S.C. Oncologia Medica
Contact Person Name
Veronica Crespi
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica Patologia Toracica
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Divisione Oncologia Toracica
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
U.O. Oncologia Medica
Contact Person Name
Marcello Tiseo
Contact Person Email
marcello.tiseo@unipr.it

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Subject Reimbursement, Site payments, Patient recruitment material creation and shipments to site.
Name
Pharmaceutical Product Development LLC
Responsibilities
PK, ADA analysis
Name
Worldwide Clinical Trials Early Phase Services LLC
Responsibilities
Integrated NCA, ADA Analyses
Name
Bioclinica Inc.
Responsibilities
ECG; ILD Adjudication
Name
Medidata Solutions Inc.
Name
WCG Clinical Inc.
Responsibilities
Safety Letter Notification

Third parties

  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"cfDNA Global","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"The Andwin Corp.","duties_or_roles":"Equipment and ancillary supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Novasco","duties_or_roles":"Reimbursement – EU","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Safety Letter Notification","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Travel Reimbursement – Spain","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"ePRO","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ILD Adjudication","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Genomic Analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK, ADA analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Bioservices Inc.","duties_or_roles":"Long Term Storage. PGx and all remaining samples, PK, ADA, tumor, blood BM","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Subject Reimbursement, Site payments, Patient recruitment material creation and shipments to site.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Metrum Research Group Inc.","duties_or_roles":"PopPK, ER Analyses","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Worldwide Clinical Trials Early Phase Services LLC","duties_or_roles":"Integrated NCA, ADA Analyses","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Patritumab deruxtecan
Active Substance
PATRITUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
1
Maximum Dose
5.60 mg/Kg
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
750 mg
Investigational Product Name
PEMETREXED
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
500 mg/m2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
75 mg/m2
Combination Treatment
Yes

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