Clinical trial • Phase III • Oncology

Humanised IgG1 monoclonal antibody against PD-L1 conjugated to monomethyl auristatin E via a valine-citrulline linker for Non-small cell lung cancer

Phase III trial of Humanised IgG1 monoclonal antibody against PD-L1 conjugated to monomethyl auristatin E via a valine-citrulline linker for Non-small cel…

Overview

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

Key dates

Initial CTIS Submission Date
31-07-2025
First CTIS Authorization Date
17-11-2025

Trial design

Randomised, open-label, docetaxel (comparator). documented dose information: up to 75 mg/m2 (doseuom mg/m2) given by intravenous infusion (max total dose amount listed 375 mg); schedule not specified in the provided data.-controlled Phase III trial in Belgium, Denmark, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Docetaxel (comparator). Documented dose information: up to 75 mg/m2 (doseUom mg/m2) given by intravenous infusion (max total dose amount listed 375 mg); schedule not specified in the provided data.
Biomarker Stratified
True, biomarker PD-L1 with strata tumor PD-L1 ≥1% and tumor PD-L1 ≥50%
Target Sample Size
434

Eligibility

Recruits 434 No vulnerable populations selected. Trial enrols adult participants only. Informed consent is required using subject information and informed consent forms (country-specific ICFs provided in the documentation)..

Vulnerable Population
No vulnerable populations selected. Trial enrols adult participants only. Informed consent is required using subject information and informed consent forms (country-specific ICFs provided in the documentation).

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of locally advanced, unresectable Stage IIIB and IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) NSCLC per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.\n- PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263\n- Participants who have NSCLC with known AGAs are permitted (eg, EGFR mutations, ALK translocations).\n- Able to provide any of the following tumor tissues for biomarker analysis: • Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or • De novo biopsy from a tumor lesion, if medically feasible.\n- Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy:  Participants with no known AGAs must fulfill 1 of the following conditions: o Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-[L]1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated. o Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-[L]1 monoclonal antibody at any time during the course of treatment.  Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions: o Must have received at least 1 approved AGA-targeted therapy and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant o Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting. o May have received PD-[L]1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy)."}

Exclusion criteria

  • {"criterion_text":"- History of another malignancy within 3 years before the first dose of PF- 08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival [OS] ≥90%), such as adequately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n- Active central nervous system (CNS) lesions are excluded. Active is defined as untreated or symptomatic requiring corticosteroids >10 mg/day of prednisone equivalent within the previous 14 days. Participants with clinically inactive, definitively treated brain metastases (surgery and/or radiotherapy) are eligible if they meet the following criteria:  The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least >14 days(if requiring steroid treatment).  No evidence of clinical and radiographic disease progression in the CNS for ≥28 days after definitive radiotherapy and/or surgery.  The use of corticosteroids at higher dose occurring ≥28 prior to the Screening visit unless it is intermittent use for other medical conditions and allowed as a concomitant therapy per Section 6.9.1.\n- Participants with a history of leptomeningeal metastasis are excluded.\n- Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives: Anti-PD-L1 Agent Prior Treatment Washout Period (Months) Atezolizumab 4.5 Durvalumab 3 Avelumab 1 Note: If the participant has been exposed to an anti-PD-L1 agent not listed above, contact the medical monitor to obtain the washout period.\n- Previous receipt of an MMAE-containing agent or prior docetaxel."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"To compare the overall survival (OS) between the experimental arm (PF-08046054) and control arm (docetaxel) in participants with tumor PD-L1 ≥1% (all participants) and participants with tumor PD-L1 ≥50%"}

Secondary endpoints

  • {"endpoint_text":"- Confirmed ORR using RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"Confirmed ORR using RECIST v1.1 as assessed by blinded independent central review (BICR)"}
  • {"endpoint_text":"- PFS using RECIST v1.1 as assessed by investigator","definition_or_measurement_approach":"PFS assessed by investigator using RECIST v1.1"}
  • {"endpoint_text":"- Confirmed ORR using RECIST v1.1 as assessed by investigator","definition_or_measurement_approach":"Confirmed ORR using RECIST v1.1 as assessed by investigator"}
  • {"endpoint_text":"- DOR using RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"Duration of Response (DOR) using RECIST v1.1 as assessed by BICR"}
  • {"endpoint_text":"- DOR using RECIST v1.1 as assessed by investigator","definition_or_measurement_approach":"Duration of Response (DOR) using RECIST v1.1 as assessed by investigator"}
  • {"endpoint_text":"- Type, incidence, severity, seriousness, and relatedness of adverse events (AEs)","definition_or_measurement_approach":"Safety characterization by type, incidence, severity, seriousness and relatedness of AEs"}
  • {"endpoint_text":"- Mean scores and change from baseline in the global health status/QoL score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Mean scores and change from baseline on EORTC QLQ-C30 global health status/QoL"}
  • {"endpoint_text":"- Mean scores and change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30","definition_or_measurement_approach":"Mean scores and change from baseline in physical functioning and role functioning on EORTC QLQ-C30"}
  • {"endpoint_text":"- Mean scores and change from baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire – Lung Cancer 13 QLQ-LC13","definition_or_measurement_approach":"Mean scores and change from baseline in dyspnea, cough and chest pain on EORTC QLQ-LC13"}
  • {"endpoint_text":"- TTdD in the global health status/QoL score on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to definitive deterioration (TTdD) in global health status/QoL on EORTC QLQ-C30"}
  • {"endpoint_text":"- TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30","definition_or_measurement_approach":"TTdD in physical functioning and role functioning scores on EORTC QLQ-C30"}
  • {"endpoint_text":"- TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13","definition_or_measurement_approach":"TTdD in dyspnea, cough and chest pain scores on EORTC QLQ-LC13"}
  • {"endpoint_text":"- Plasma concentration at end of infusion and plasma predose concentration for antibody conjugated monomethyl auristatin E (ac-MMAE) and unconjugated monomethyl auristatin E (MMAE) (in PF-08046054 treatment arm only)","definition_or_measurement_approach":"PK sampling: plasma concentration at end of infusion and pre-dose for ac-MMAE and unconjugated MMAE (PF-08046054 arm only)"}
  • {"endpoint_text":"- Incidence of ADA (in PF-08046054 treatment arm only)","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADA) in PF-08046054 treatment arm"}
  • {"endpoint_text":"- PFS using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by BICR","definition_or_measurement_approach":"Progression-free survival using RECIST v1.1 as assessed by blinded independent central review (BICR)"}

Recruitment

Digital Remote Recruitment
True, methods documented include Digital Outreach Decks, OUS Patient Study Webpage, digital outreach materials and electronic patient-reported outcomes/eCOA/ePRO systems (IQVIA listed for ePRO/eCOA).
Planned Sample Size
434
Recruitment Window Months
24
Consent Approach
Informed consent obtained via subject information and informed consent forms. Country-specific ICFs are provided (multiple language versions present in the documents list). Participants provide their own consent (adult population); no assent for minors is applicable. Languages available via the provided ICFs include, for example, English, French, Dutch, Spanish, Italian, Polish, Swedish, Czech, Bulgarian, Greek, German, Danish and Finnish (country-specific ICF documents listed).

Methods

  • Use of country-specific recruitment arrangements (K1 documents) and recruitment materials (K2 documents) including: advocacy alerts, advocacy information cards, study brochures, study posters, ICD flipcharts, biopsy flyers, digital outreach decks, and patient study webpages (documents listed per country).
  • Sponsor and third-party recruitment support (third parties listed include organisations responsible for patient recruitment and retention).

Geography

Total Number Of Sites
100
Total Number Of Participants
246

Belgium

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
28
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
A.Z. Sint-Maarten
Department Name
Pneumology
Contact Person Name
Marc Lambrechts
Contact Person Email
marc.lambrechts@emmaus.be
Site Name
Jessa Ziekenhuis
Department Name
Pneumology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology & Hematology
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Algemeen Ziekenhuis Klina
Department Name
Oncology
Contact Person Name
Wim Demey
Contact Person Email
Wim.demey@klina.be

Denmark

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
18
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Aarhus University Hospital
Department Name
Department of Oncology
Contact Person Name
Peter Meldgaard
Contact Person Email
petemeld@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Lotte Land
Contact Person Email
lotte.holm.land@rsyd.dk
Site Name
Zealand University Hospital
Department Name
Department of Clinical Oncology and Palliative Care
Contact Person Name
Malene Frank
Contact Person Email
malf@regionsjaelland.dk
Site Name
Herlev Hospital
Department Name
Department of Oncology
Contact Person Name
Jon Andersen
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Mette Poehl
Contact Person Email
mette.poehl@regionh.dk

Spain

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
59
Number Of Sites
13
Number Of Participants
31

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Andres Barba Joaquin
Contact Person Email
abarba@santpau.cat
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncology
Contact Person Name
Paula Espinosa Olarte
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Contact Person Name
Silvia Sequero Lopez
Contact Person Email
silsq90@gmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Gonzaga Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Hospital Universitario De Badajoz
Department Name
Oncology
Contact Person Name
Veronica Serrano Pecos
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Rosa Alvarez Alvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
University Hospital Son Espases
Department Name
Oncology
Contact Person Name
Raquel Marse Fabregat
Contact Person Email
raquel.marse@ssib.es

Finland

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
27
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
HUS-yhtymae
Department Name
Comprehensive Cancer Center
Contact Person Name
Ilkka Liikanen
Contact Person Email
ilkka.liikanen@hus.fi
Site Name
Turku University Hospital
Department Name
The Department of Pulmonary Medicine
Contact Person Name
Maria Silvoniemi
Contact Person Email
maria.silvoniemi@varha.fi
Site Name
Vaasa Central Hospital
Department Name
Department of Clinical Oncology
Contact Person Name
Ravichandra Ravi
Contact Person Email
ravichandra.ravi@ovph.fi
Site Name
Kuopio University Hospital
Department Name
Syöpätautien poliklinikka
Contact Person Name
Okko Kääriäinen

Bulgaria

Earliest CTIS Part Ii Submission Date
06-11-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
82
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
MBAL Trakia EOOD
Department Name
Department of medical oncology
Contact Person Name
Rumyana Ilieva
Contact Person Email
dr.rumyanailieva@gmail.com
Site Name
University Specialized Hospital For Active Treatment In Oncology EAD
Department Name
Clinic - Medical Oncology
Contact Person Name
Assia Konsoulova
Contact Person Email
dr.konsoulova@gmail.com
Site Name
Mbal Za Zhensko Zdrave Nadezhda OOD
Department Name
Clinic of Medical Oncology
Contact Person Name
Mila Petrova
Contact Person Email
milllapetrova@gmail.com
Site Name
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department Name
Department of medical oncology
Contact Person Name
Stoil Boychev
Contact Person Email
dr.stoil.boichev@gmail.com
Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Department of Medical Oncology
Contact Person Name
Rossitza Krasteva Ruseva

Slovakia

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
113
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Fakultna Nemocnica S Poliklinikou Nove Zamky
Department Name
Department of Clinical Oncology
Contact Person Name
Pavol Demo
Contact Person Email
pavoldemo@centrum.sk
Site Name
Narodny Onkologicky Ustav
Department Name
Department of Clinical Oncology E
Contact Person Name
Robert Godal
Contact Person Email
robert.godal@nou.sk
Site Name
University Hospital Bratislava
Department Name
Department of Clinical Oncology
Contact Person Name
Zuzana Svihelova Liskova
Contact Person Email
zuzana.svihel@gmail.com
Site Name
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Department Name
Department of Clinical Oncology
Contact Person Name
Lenka Rusinova

Sweden

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
154
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Verksamhet onkologi
Contact Person Name
Charlotta Fröjd
Contact Person Email
charlotta.a.frojd@vgregion.se
Site Name
Region Gaevleborg
Department Name
VO Internmedicin, Lungenheten
Contact Person Name
Johan Isaksson
Site Name
Malarsjukhuset Eskilstuna
Contact Person Name
Andreas Nearchou

Greece

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
154
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine and Laboratory
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine-Oncology Departmant
Contact Person Name
Sofia Agelaki
Contact Person Email
agelaki@uoc.gr
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic Department of Chemotherapy
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Oncology
Contact Person Name
Elena Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
Fourth Department of Oncology and Clinical Trials Unit
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
International Oncology Center/ Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Metropolitan Hospital
Department Name
4th Oncology Department
Contact Person Name
Helena Linardou

Italy

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
105
Number Of Sites
12
Number Of Participants
36

Sites

Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SODc Clinical Oncology
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Oncologia
Contact Person Name
Sara Pilotto
Contact Person Email
sara.pilotto@univr.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UOC Oncologia Medica - Ospedale Santa Maria delle Croci
Contact Person Name
Chiara Bennati
Contact Person Email
chiara.bennati@auslromagna.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia Medica e dei Tumori Immunocorrelati
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Medica
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Ospedaliera Dei Colli Ospedale Monaldi
Department Name
UOC di Pneumologia Oncologica
Contact Person Name
Danilo Rocco
Contact Person Email
danilorocc@yahoo.it
Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
UOC Oncologia Medica
Contact Person Name
Emilio Bria
Contact Person Email
emilio.bria@fbf-isola.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Azienda Ospedaliera Sant'Anna E San Sebastiano Di Caserta
Department Name
ONCOHEMATOLOGY
Contact Person Name
Michele Orditura
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Internal Medicine and medical Specialties
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Humanitas Gavazzeni - U.O. Oncologia Medica – Unità di Oncologia Toracica
Contact Person Name
Chiara Matilde Catania
Contact Person Email
chiara.catania@gavazzeni.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Toracica
Contact Person Name
Ilaria Attili
Contact Person Email
ilaria.attili@ieo.it

Poland

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
88
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Chemioterapii
Contact Person Name
Rodryg Ramlau
Contact Person Email
rodrygramlau@gmail.com
Site Name
Jagiellonskie Centrum Innowacji Sp. z o.o.
Contact Person Name
Wojciech Piskorski
Contact Person Email
piskorski@tlen.pl
Site Name
Instytut Msf Sp. z o.o.
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Instytut Genetyki I Immunologii Genim Sp. z o.o.
Contact Person Name
Izabela Chmielewska
Contact Person Email
izachm@wp.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Contact Person Name
Magdalena Ciążyńska
Contact Person Email
ciazynska.magdalena@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
103
Number Of Sites
15
Number Of Participants
32

Sites

Site Name
Klinikum Aschaffenburg-Alzenau
Department Name
MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie
Contact Person Name
Manfred Welslau
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV, Organonkologie
Contact Person Name
Thomas Wehler
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Hämatologie, Onkologie und Immunologie
Contact Person Name
Barbara Ritter
Contact Person Email
barbara.ritter@gnh.net
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Contact Person Name
Jakob Hammersen
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Abteilung für Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Martin Kimmich
Contact Person Email
martin.kimmich@rbk.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik (Tumorforschung), WTZ-Ambulanz
Contact Person Name
Gregor Zaun
Contact Person Email
gregor.zaun@uk-essen.de
Site Name
Lungenfachklinik Immenhausen
Contact Person Name
Achim Rittmeyer
Site Name
Johanniter-Krankenhaus Treuenbrietzen
Contact Person Name
Konrad Wetzer
Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für internistische Onkologie und Hämatologie
Contact Person Name
Ekkehard Eigendorff
Contact Person Email
onk@zentralklinik.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Moritz Kleemiß
Contact Person Email
moritz.kleemiss@ukbonn.de
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Lungen- & Thoraxzentrum Nordrhein
Contact Person Name
Karl-Otto Kambartel
Site Name
Krankenhaus Nordwest GmbH
Department Name
Klinik für Onkologie und Hämatologie
Contact Person Name
Akin Atmaca
Contact Person Email
atmaca.akin@khnw.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Universitären Lungenkrebszentrums des Saarlandes
Contact Person Name
Jan Stratmann
Contact Person Email
jan.stratmann@uks.eu
Site Name
Thoraxklinik Heidelberg gGmbH
Contact Person Name
Michael Thomas
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik III
Contact Person Name
Sabine Bohnet
Contact Person Email
sabine.bohnet@uksh.de

Netherlands

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
109
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
St. Antonius Ziekenhuis
Contact Person Name
Lisanne Kastelijn
Site Name
Academisch Ziekenhuis Maastricht
Contact Person Name
Lizza Hendriks
Contact Person Email
lizza.hendriks@mumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Contact Person Name
Daphne Dumoulin
Contact Person Email
d.dumoulin@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Pulmonology
Contact Person Name
Sayed Hashemi
Contact Person Email
s.hashemi@amsterdamumc.nl

France

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
06-01-2026
Processing Time Days
109
Number Of Sites
13
Number Of Participants
38

Sites

Site Name
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Contact Person Name
Laurent Greillier
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
CHU de Rouen - Hôpital Charles Nicolle
Department Name
Pneumology, Intensive Care and Thoracic Oncology
Contact Person Name
Florian Guisier
Contact Person Email
Florian.Guisier@chu-rouen.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Contact Person Name
Renaud Descourt
Contact Person Email
renaud.descourt@chu-brest.fr
Site Name
Institut Curie
Department Name
Thorax Institute
Contact Person Name
Nicolas Girard
Contact Person Email
NICOLAS.GIRARD2@CURIE.FR
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de Pneumologie
Contact Person Name
Yannick Le Guen
Contact Person Email
Yannick.le.guen@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Pneumologie
Contact Person Name
Julien Mazieres
Contact Person Email
mazieresjulien@gmail.com
Site Name
Hopital Tenon
Department Name
Unité d`Oncologie Thoracique
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
Institut Bergonié
Department Name
Medical Oncology
Contact Person Name
Sophie Cousin
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Hopitaux Universitaires Paris Centre-Hopital Cochin
Department Name
Unité d`Oncologie Thoracique
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Department Name
Lung Oncology
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Gustave Roussy
Contact Person Name
David Planchard
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pôle Thorax et Vaisseaux - Clinique de Pneumologie
Contact Person Name
Denis Moro-Sibilot
Site Name
CHU Lille - Institut Coeur Poumon
Department Name
Pulmonology and Thoracic Oncology
Contact Person Name
Alexis Cortot
Contact Person Email
alexis.cortot@chru.lille.fr

Czechia

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
49
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddělení radioterapie a onkologie
Contact Person Name
Vojtěch Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.cz
Site Name
Fakultní nemocnice Brno
Department Name
Klinika nemocí plicních a tuberkulózy
Contact Person Name
Bohdan Kadlec
Contact Person Email
kadlec.bohdan@fnbrno.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
Fakultní nemocnice v Motole
Department Name
Pneumologická klinika 2. LF UK a FN Motol
Contact Person Name
Leona Koubková
Contact Person Email
leona.koubkova@fnmotol.cz
Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Plicní ambulance – pneumoonkologická ambulance
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz
Site Name
Všeobecná fakultní nemocnice v Praze
Department Name
Onkologická klinika
Contact Person Name
Milada Zemanová
Contact Person Email
vfn@vfn.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Development LP
Responsibilities
PK Lab
Name
Parexel International Corp.
Responsibilities
sourcing, shipment and distribution of all ancillary supplies (ex. equipment and central lab supplies)
Name
Icon Clinical Research Limited
Responsibilities
On-study storage, tissue block processing
Name
Icon Development Solutions LLC
Responsibilities
PK Lab
Name
Icon Laboratory Services Inc.
Responsibilities
Central Imaging Vendor/Central Read Vendor; Clinical Lab Services
Name
IQVIA Biotech LLC
Responsibilities
Electronic Patient Reported Outcomes (ePROs), Electronic Clinical Outcome Assessment (eCOAs)
Name
WCG Clinical Inc.
Responsibilities
Patient Recruitment and Retention

Third parties

  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long Term Storage - Biofluids and Tissue","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"PK Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Materials; websites; campaigns; site recruitment support.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"Clinical Lab Services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"Assay Testing Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Central Imaging Vendor/Central Read Vendor","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sourcing, shipment and distribution of all ancillary supplies (ex. equipment and central lab supplies)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"On-study storage, tissue block processing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"Assay testing vendor","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"PK Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Companion Diagnostics Testing - Retrospective Testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Electronic Patient Reported Outcomes (ePROs), Electronic Clinical Outcome Assessment (eCOAs)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"On-study storage, tissue block processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"Assay testing vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Central Imaging Vendor/Central Read Vendor","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
PF-08046054 (SGN-PDL1V)
Active Substance
Humanised IgG1 monoclonal antibody against PD-L1 conjugated to monomethyl auristatin E via a valine-citrulline linker
Modality
ADC
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Starting Dose
1.5 mg/kg (doseUom mg/kg listed, maxDailyDoseAmount 1.5)
Maximum Dose
1.5 mg/kg
Investigational Product Name
Docetaxel
Active Substance
Docetaxel
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Starting Dose
75 mg/m2 (doseUom mg/m2 listed, maxDailyDoseAmount 75)
Maximum Dose
375 mg (maxTotalDoseAmount 375)

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