Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Squamous non-small cell lung cancer

Phase III trial of SACITUZUMAB TIRUMOTECAN for Squamous non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Squamous non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | ADC

Key dates

Initial CTIS Submission Date
17-04-2024
First CTIS Authorization Date
12-08-2024

Trial design

Randomised, induction: pembrolizumab in combination with carboplatin plus taxane (paclitaxel or nab‑paclitaxel) followed by randomization to pembrolizumab with maintenance mk‑2870 versus pembrolizumab without maintenance mk‑2870 (doses/schedules not specified in provided data).-controlled Phase III trial in Ireland, Romania, Austria and others.

Randomised
Yes
Comparator
Induction: pembrolizumab in combination with carboplatin plus taxane (paclitaxel or nab‑paclitaxel) followed by randomization to pembrolizumab with maintenance MK‑2870 versus pembrolizumab without maintenance MK‑2870 (doses/schedules not specified in provided data).
Target Sample Size
575

Eligibility

Recruits 575 No vulnerable populations were selected (isVulnerablePopulationSelected = false). Informed consent is collected from adult participants; country-specific ICF documents are provided (adult consent forms and addenda). No assent/parental consent procedures for minors are specified..

Vulnerable Population
No vulnerable populations were selected (isVulnerablePopulationSelected = false). Informed consent is collected from adult participants; country-specific ICF documents are provided (adult consent forms and addenda). No assent/parental consent procedures for minors are specified.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8).\n- Has adequate organ function.\n- For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by blinded independent central review (BICR) using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization.\n- For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit.\n- For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered.\n- Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.\n- Life expectancy of at least 3 months.\n- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 assessed within 7 days before allocation.\n- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.\n- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).\n- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible). Note: Participants with Grade =2 neuropathy are eligible."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.\n- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval by Fridericia (QTcF) interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention.\n- HIV-infected participants who have been newly diagnosed or with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.\n- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.\n- Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n- Is currently receiving a strong inducer/inhibitor of Cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks.\n- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n- Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy.\n- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- Active infection requiring systemic therapy.\n- History of allogeneic tissue/solid organ transplant.\n- Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n- Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).\n- Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by blinded independent central review (BICR)."}
  • {"endpoint_text":"- Number of Participants With One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing one or more adverse events."}
  • {"endpoint_text":"- Number of Participants Discontinuing from Study Therapy Due to AE(s)","definition_or_measurement_approach":"Count of participants discontinuing study therapy due to adverse event(s)."}
  • {"endpoint_text":"- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)","definition_or_measurement_approach":"Change from baseline to predefined timepoint using EORTC QLQ-C30 items 29 and 30."}
  • {"endpoint_text":"- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)","definition_or_measurement_approach":"Change from baseline to predefined timepoint using EORTC QLQ-C30 item 8."}
  • {"endpoint_text":"- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)","definition_or_measurement_approach":"Change from baseline to predefined timepoint using EORTC QLQ-LC13 item 31."}
  • {"endpoint_text":"- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)","definition_or_measurement_approach":"Change from baseline to predefined timepoint using EORTC QLQ-LC13 item 40."}
  • {"endpoint_text":"- Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)","definition_or_measurement_approach":"Time to first deterioration measured by EORTC QLQ-C30 items 29 and 30."}
  • {"endpoint_text":"- TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)","definition_or_measurement_approach":"Time to first deterioration measured by EORTC QLQ-C30 item 8."}
  • {"endpoint_text":"- TTD in Cough Score (EORTC QLQ-LC13 Item 31)","definition_or_measurement_approach":"Time to first deterioration measured by EORTC QLQ-LC13 item 31."}
  • {"endpoint_text":"- TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)","definition_or_measurement_approach":"Time to first deterioration measured by EORTC QLQ-LC13 item 40."}

Recruitment

Registry Or Advocacy Recruitment
True, Patient advocacy (document 'L1_Patient advocacy_AUT_DE_for pub' listed for Austria).
Digital Remote Recruitment
True, use of online/banner advertisements, study-specific websites, digital patient brochures and online patient-facing recruitment materials are documented (country-specific K2 documents such as banner ads, website materials, patient brochures).
Planned Sample Size
575
Recruitment Window Months
80
Consent Approach
Informed consent is obtained from adult participants via local language subject information and informed consent forms. Country-specific ICF documents are provided for multiple languages (examples: EN, RO, DE, FR, ES, IT, HU, CS/CZE, PL). Consent packets include main consent forms and optional/addendum forms (eg, disease progression addendum, genetic consent, optional partner forms). No procedures for parental consent/assent for minors are specified.

Methods

  • Country-specific recruitment arrangements documents are provided (e.g., 'Recruitment Arrangements and IC Procedure' per country).
  • Printed patient materials: patient brochures and posters (documents titled 'K2_Recruitment Doc Patient Brochure', 'K2_Recruitment Doc Poster') used at site level.
  • Digital materials: banner ads and website pages for recruitment (e.g., 'K2_Recruitment Doc Patient Banner Ad' in Romania; 'K2_Recruitment Doc Website' in Poland).
  • Site outreach and clinical trial brochures ('K2_Recruitment Doc Clinical Trial Brochure', 'K2_Recruitment Doc Patient Visit Guide').
  • Centralized support (EUB services/call centre) provided by Parexel as listed in sponsor third-party duties.

Geography

Total Number Of Sites
64
Total Number Of Participants
301

Ireland

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
49
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
St James's Hospital
Department Name
Oncology
Contact Person Name
Sinead Cuffe

Romania

Earliest CTIS Part Ii Submission Date
30-04-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
111
Number Of Sites
9
Number Of Participants
45

Sites

Site Name
Onco Card S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Bogdan-Daniel CARLAN
Contact Person Email
office@medlife.ro
Site Name
Cardiomed S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Calin -Ioan CAINAP
Contact Person Email
office@cardiomedcluj.ro
Site Name
Medicover S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Radu-Emanuel BERCEANU-ION
Contact Person Email
ofice@medicover.ro
Site Name
Lotus Med S.R.L.
Department Name
Dept. of Oncology
Contact Person Name
Anca-Florina ZGURA
Contact Person Email
anca.zgura@lotus-med.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Andrei UNGUREANU
Site Name
Clinica Polisano S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Victor-Marian NIMIRCEAG
Contact Person Email
office.polisano@medlife.ro
Site Name
Oncomed S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Daniela-Elvira SIRBU
Contact Person Email
cabinet_oncomed@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Michael SCHENKER
Contact Person Email
office@centruldeoncologie.ro
Site Name
Clinica/other (as listed)

Austria

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
41
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Klinik Hietzing
Department Name
Klinik Hietzing Innere Medizin mit Pneumologie
Contact Person Name
Robab Breyer-Kohansal
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
Contact Person Name
Maximilian Hochmair
Site Name
Ordensklinikum Linz GmbH
Department Name
Elisabethinen Lungenabteilung / Pneumologie
Contact Person Name
Michael Schumacher
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Klinik Penzing Abteilung für Atemwegs- und Lungenkrankheiten
Contact Person Name
Marie-Kathrin Breyer

Spain

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
13
Number Of Sites
6
Number Of Participants
34

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Nuria Pardo Aranda
Contact Person Email
npardo@vhio.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medical Oncology
Contact Person Name
Luis León Mateos
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Virgen De Valme
Department Name
Medical Oncology
Contact Person Name
José Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Contact Person Name
Manuel Domine Gómez
Site Name
Hospital Quironsalud Malaga
Department Name
Medical Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es

Hungary

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
18
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Pulmonológia
Contact Person Name
Sándor Tehenes
Contact Person Email
tehenes.pul@zmkorhaz.hu
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkopulmonológiai Járóbeteg Centrum
Contact Person Name
Gabriella Gálffy
Contact Person Email
galffy.gabriella@rpckorhaz.hu
Site Name
Koranyi National Institute For Pulmonology
Department Name
VI. Tüdőbelosztály (Bronchológia)
Contact Person Name
Andrea Fülöp
Contact Person Email
fulop.andrea@koranyi.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsuzsanna Kelemen
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonológia Osztály
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Onkológiai Központ
Contact Person Name
Anna Andrea Lengyel
Contact Person Email
lengyelanna66@freemail.hu

Czechia

Earliest CTIS Part Ii Submission Date
18-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
27
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Plicní oddělení
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz
Site Name
Multiscan s.r.o.
Department Name
Onkologické a radiologické centrum
Contact Person Name
Karel Odrážka
Contact Person Email
odrazka@multiscan.cz
Site Name
University Hospital Olomouc
Department Name
Klinika plicních nemocí a tuberkulózy
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Contact Person Name
Ondřej Bílek
Contact Person Email
bilek@mou.cz

France

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
145
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Service Oncologie médicale
Contact Person Name
Frederic Bigot
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Unité fonctionnelle Onco-thoracique
Contact Person Name
Naila Bacha Dufour
Contact Person Email
n.bachadufor@isc84.org
Site Name
Hopital Prive Clairval
Department Name
Service Oncologie médicale
Contact Person Name
Jean-Baptiste Paoli
Contact Person Email
jb.paoli@free.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Service de pneumologie
Contact Person Name
Acya Bizieux
Contact Person Email
Acya.bizieux@chd-vendee.fr
Site Name
Hopitaux Prives De Metz
Department Name
Service de pneumologie
Contact Person Name
Julie Perrin
Contact Person Email
julie.perrin@uneos.fr

Italy

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
42
Number Of Sites
12
Number Of Participants
33

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Contact Person Name
Giuseppe Lo Russo
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Contact Person Name
Gloria Borra
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Centro Ricerche Cliniche di Verona S.r.l.
Contact Person Name
Lorenzo Belluomini
Contact Person Email
lorenzo.belluomini@univr.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Unità di Oncologia Medica ed Ematologia
Contact Person Name
Giovanna Finocchiaro
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncologia Medica
Contact Person Name
Salvatore Grisanti
Contact Person Email
salvatore.grisanti@unibs.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
S.C. Oncologia
Contact Person Name
Elena Bolzacchini
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Centro Clinico di Fase 1
Contact Person Name
Gabriele Minuti
Contact Person Email
gabriele.minuti@ifo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Unità di Oncologia Medica
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
Azienda Ospedaliera S Giovanni Addolorata
Department Name
UON Oncologia
Contact Person Name
Antonio Lugini
Contact Person Email
alugini@hsangiovanni.roma.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Oncologia Medica
Contact Person Name
Diego Cortinovis
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Dipartimento Toraco-polmonare
Contact Person Name
Alessandro Morabito
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncologia
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@sanmatteo.pv.it

Germany

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
38
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Innere Medizin, Pneumologie, Hämatologie / Onkologie
Contact Person Name
Dagmar Täuscher
Contact Person Email
studienzentrum.wkg@srh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Fächerverbund für Infektiologie, Pneumologie und Intensivmedizin
Contact Person Name
Nikolaj Frost
Contact Person Email
studien-pneumologie@charite.de
Site Name
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH
Department Name
Gemeinschaftspraxis Schulte Lipke
Contact Person Name
Clemens Schulte
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik III/Pneumologie
Contact Person Name
Sabine Bohnet
Site Name
Krankenhaus Bethanien gGmbH
Department Name
Institut für Pneumologie an der Universität zu Köln
Contact Person Name
Lars Hagmeyer
Contact Person Email
institut@klinik-bethanien.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Internistische Onkologie/Hämatologie
Contact Person Name
Sebastian W. Ertl
Contact Person Email
s.ertl@kem-med.com

Poland

Earliest CTIS Part Ii Submission Date
08-07-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
36
Number Of Sites
11
Number Of Participants
64

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@nio.gov.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej im. dr E. Pileckiej z pododdziałem Chemioterapii Dziennej
Contact Person Name
Iwona Zakrzewska
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział onkologiczny z Pododdziałem dziennej chemioterapii
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl
Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
III Klinika Chorób Płuc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
3klinika@igichp.edu.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Szpital Specjalistyczny Im. Henryka Klimontowicza W Gorlicach
Department Name
Oddział Onkologiczny
Contact Person Name
Łukasz Pierzchała
Contact Person Email
l.pierzchala@gmail.com
Site Name
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Urszula Sadowska
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Innowacyjnych Terapii
Contact Person Name
Tomasz Jankowski
Contact Person Email
tjankowski.onkolog@wp.pl

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Q Squared Solutions Limited
Responsibilities
Operational support (role code 4 as listed)

Third parties

  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging (code 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services) (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"code 4","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Optional Services: patient travel services, payments (code 15)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Services for eCOA patient questionnaires (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Investigational (no marketing authorisation listed)
Maximum Dose
208 mg/kg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation EU/1/15/1024/002)
Maximum Dose
10800 mg
Combination Treatment
Yes

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