Clinical trial • Phase III • Oncology

PF-08634404 for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer

Phase III trial of PF-08634404 for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer.

Overview

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

Key dates

Initial CTIS Submission Date
19-11-2025
First CTIS Authorization Date
24-03-2026

Trial design

Randomised, pembrolizumab in combination with chemotherapy (control arm). Phase III trial in Czechia, Spain, Poland and others.

Randomised
Yes
Comparator
Pembrolizumab in combination with chemotherapy (control arm).
Target Sample Size
1023

Eligibility

Recruits 1023 Vulnerable population not selected (isVulnerablePopulationSelected=false). Inclusion requires participants to be ≥18 years of age. Subject information and informed consent forms are provided (multiple L1 main ICD documents listed for different countries/languages). A 'Child RIF' document is present in French materials, but the eligibility criteria exclude participants under 18..

Pregnancy Exclusion
Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false). Inclusion requires participants to be ≥18 years of age. Subject information and informed consent forms are provided (multiple L1 main ICD documents listed for different countries/languages). A 'Child RIF' document is present in French materials, but the eligibility criteria exclude participants under 18.

Inclusion criteria

  • {"criterion_text":"-18 years of age or older\n-Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative chemoradiation per the AJCC Staging Manual and the UICC Staging System (Eighth edition).\n-Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n-PD-L1 status available based on local testing results\n-Measurable disease based on RECIST v1.1 per investigator.\n-ECOG PS score of 0 or 1\n-Expected survival ≥12 weeks"}

Exclusion criteria

  • {"criterion_text":"-Participants with known AGAs, including EGFR, ALK, ROS1, NTRK, BRAF, RET, and MET, for which there are approved first-line therapies per local SOC are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.\n-Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.\n-History of severe bleeding tendency or coagulation dysfunction\n-History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n-Participants with acute, chronic or symptomatic infections including participants positive for active HIV, HBV, or HCV.\n-Participants with history of immunodeficiency\n-Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n-Previous systemic anti-tumor therapy including: -Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. a) (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose. b) Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose. -Previous treatment with immunotherapy. -Prior radiotherapy to the lung < 6 months of first dose of study intervention. -Palliative local therapy < 2 weeks before the first dose. -Non-specific immunomodulatory therapy < 2 weeks before the first dose. -Prior systemic anti-angiogenic therapy.\n-Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.\n-Prior and concomitant therapy: -Therapeutic oral or parenteral anticoagulants or thrombolytic agents < 10 days to the first dose. -Chronic antiplatelet therapy <7 days to randomization. Live or attenuated live vaccine < 4 weeks to the first dose. -Current high-dose systemic corticosteroids. -Prohibited concomitant medication(s) < 21 days to the first dose.\n-Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.\n-Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter < 1 cm are permitted.\n-Participants with clinically significant risk of hemorrhage or fistula are excluded.\n-Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n-Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n-Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n-History of allogeneic organ / hematopoietic stem cell transplantation.\n-Participants with any of the following respiratory conditions:-Evidence of noninfectious or drug-induced ILD or pneumonitis -Known DLCO (adjusted for hemoglobin) <50% predicted. -Grade ≥3 pulmonary disease unrelated to underlying malignancy.\n-History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes and arterial/severe venous thromboembolic events."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Overall survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"-PFS using RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"PFS measured using RECIST v1.1 and assessed by Blinded Independent Central Review (BICR)."}

Secondary endpoints

  • {"endpoint_text":"-1. Key - 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":"-2. PFS using RECIST v1.1 as assessed by investigator; Confirmed ORR using RECIST v1.1 as assessed by investigator; DoR using RECIST v1.1 as assessed by BICR; DoR using RECIST v1.1 as assessed by investigator","definition_or_measurement_approach":"PFS and ORR and DoR measured using RECIST v1.1 with assessments by investigator and BICR as specified."}
  • {"endpoint_text":"-3. AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s); Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing.","definition_or_measurement_approach":"Adverse events graded by NCI CTCAE v5.0; laboratory abnormalities graded by NCI CTCAE v5.0."}
  • {"endpoint_text":"-4. Predose and postdose concentrations of PF-08634404.","definition_or_measurement_approach":"Measurement of predose and postdose PF-08634404 plasma concentrations (PK sampling)."}
  • {"endpoint_text":"-5. Incidence of ADA against PF-08634404","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADA) incidence against PF-08634404."}
  • {"endpoint_text":"-6. Change from baseline in the global health status/QoL, and Physical function scores on the EORTC QLQ-C30; Change from baseline in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13; Time to definitive deterioration in the global health status/QoL and physical function scores on the EORTC QLQ-C30; Time to definitive deterioration in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13","definition_or_measurement_approach":"Patient-reported outcomes using EORTC QLQ-C30 and EORTC QLQ-LC13 instruments; changes from baseline and time to definitive deterioration measured as specified."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
1023
Recruitment Window Months
76
Consent Approach
Informed consent obtained from adult participants (eligibility requires ≥18 years). Subject information and informed consent form (L1 Main ICD and related ICD documents) are provided for multiple countries/languages (examples: CZ, ES, PL, HU, FR, DE, IT, GR). A 'Child RIF' document is present in French materials, but children are excluded by eligibility criteria.

Methods

  • Global Participant Website (documents present for ES, PL, DE and other locales) - online trial information for potential participants
  • Global Facebook Page / Global Facebook materials - social media channel for outreach
  • Participant Paid Search Keywords - paid search advertising materials (country-specific variants listed)
  • Participant Outreach Image Library - outreach imagery for recruitment
  • Study Brochure / Clinical Trial Fact Sheet - informational brochures for potential participants and clinicians
  • Participant Media Board / Participant Outreach Materials - media assets for recruitment
  • Global Participant Website Layout / Website Layout documents - web design/layout assets for participant-facing site

Geography

Total Number Of Sites
96
Total Number Of Participants
387

Czechia

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
22
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Plicni oddeleni
Principal Investigator Name
Jaromir Roubec
Principal Investigator Email
jaromir.roubec@vtn.agel.cz
Contact Person Name
Jaromir Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz
Site Name
Multiscan s.r.o.
Principal Investigator Name
Karel Odrazka
Principal Investigator Email
odrazka@multiscan.cz
Contact Person Name
Karel Odrazka
Contact Person Email
odrazka@multiscan.cz
Site Name
University Hospital Olomouc
Department Name
Klinika plicnich nemoci a tuberkulozy
Principal Investigator Name
Juraj Kultan
Principal Investigator Email
juraj.kultan@fnol.cz
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Pneumologicka klinika 1. LF UK a FTN
Principal Investigator Name
Marie Drosslerova
Principal Investigator Email
marie.drosslerova@ftn.cz
Contact Person Name
Marie Drosslerova
Contact Person Email
marie.drosslerova@ftn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika nemoci plicnich a tuberkulozy
Principal Investigator Name
Bohdan Kadlec
Principal Investigator Email
kadlec.bohdan@fnbrno.cz
Contact Person Name
Bohdan Kadlec
Contact Person Email
kadlec.bohdan@fnbrno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Pneumologicka klinika 2. LF UK a FN Motol
Principal Investigator Name
Leona Koubkova
Principal Investigator Email
leona.koubkova@fnmotol.cz
Contact Person Name
Leona Koubkova
Contact Person Email
leona.koubkova@fnmotol.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddeleni radioterapie a onkologie
Principal Investigator Name
David Vrana
Principal Investigator Email
david.vrana@nnj.agel.cz
Contact Person Name
David Vrana
Contact Person Email
david.vrana@nnj.agel.cz
Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s. (duplicate listing not expected)
Department Name
Plicni oddeleni
Principal Investigator Name
Jaromir Roubec
Principal Investigator Email
jaromir.roubec@vtn.agel.cz
Contact Person Name
Jaromir Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz

Spain

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
30
Number Of Sites
21
Number Of Participants
120

Sites

Site Name
Hospital Insular de Gran Canarias
Department Name
Oncology
Principal Investigator Name
Delvys Rodriguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Departamento de Oncologia- VHIO
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Department of Oncology
Principal Investigator Name
Manuel Domine Gomez
Principal Investigator Email
ensayoscancerpulmonfjd@gmail.com
Contact Person Name
Manuel Domine Gomez
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Principal Investigator Name
Rosa Maria Alvarez Alvarez
Principal Investigator Email
rosa.alvarez.al@gmail.com
Contact Person Name
Rosa Maria Alvarez Alvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Hospital Universitario De Torrejon
Department Name
Unidad de Investigación Clínica
Principal Investigator Name
Luis Cabezón-Gutiérrez
Principal Investigator Email
lcabezon@torrejonsalud.com
Contact Person Name
Luis Cabezón-Gutiérrez
Contact Person Email
lcabezon@torrejonsalud.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Medical Oncology
Principal Investigator Name
Silvia Sequero Lopez
Principal Investigator Email
silsq90@gmail.com
Contact Person Name
Silvia Sequero Lopez
Contact Person Email
silsq90@gmail.com
Site Name
University Hospital Son Espases
Department Name
Servico de Oncología
Principal Investigator Name
Raquel Marse Fabregat
Principal Investigator Email
raquel.marse@ssib.es
Contact Person Name
Raquel Marse Fabregat
Contact Person Email
raquel.marse@ssib.es
Site Name
Hospital De Jerez De La Frontera
Department Name
Oncología Médica
Principal Investigator Name
Jesus Corral Jaime
Contact Person Name
Jesus Corral Jaime
Site Name
Hospital General Universitario De Elche
Department Name
Oncología Médica
Principal Investigator Name
Javier David Benitez Fuentes
Principal Investigator Email
javierdavidbenitezfuentes@gmail.com
Contact Person Name
Javier David Benitez Fuentes
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Luis Paz-Ares Rodriguez
Principal Investigator Email
lpazaresr@seom.org
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology Department
Principal Investigator Name
Manuel Barba Joaquin
Principal Investigator Email
abarba@santpau.cat
Contact Person Name
Manuel Barba Joaquin
Contact Person Email
abarba@santpau.cat
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Principal Investigator Name
Joaquim Bosch Barrera
Principal Investigator Email
jbosch@iconcologia.net
Contact Person Name
Joaquim Bosch Barrera
Contact Person Email
jbosch@iconcologia.net
Site Name
Hospital Del Mar
Department Name
Medical Oncology Department
Principal Investigator Name
Edurne Arriola Aperribay
Principal Investigator Email
earriola@hmar.cat
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@hmar.cat
Site Name
Hospital Universitario De Toledo
Department Name
Oncology
Principal Investigator Name
Ruth Alvarez Cabellos
Principal Investigator Email
ruthalvarez21@gmail.com
Contact Person Name
Ruth Alvarez Cabellos
Contact Person Email
ruthalvarez21@gmail.com
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Oncología médica
Principal Investigator Name
Angel Inoriza Rueda
Principal Investigator Email
angel.inoriza@hotmail.com
Contact Person Name
Angel Inoriza Rueda
Contact Person Email
angel.inoriza@hotmail.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Departamento de Oncologia
Principal Investigator Name
Jose Fuentes Pradera
Principal Investigator Email
fuentespradera@hotmail.com
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Principal Investigator Name
Mónica Antoñanzas Basa
Principal Investigator Email
monica.antonanzas@salud.madrid.org
Contact Person Name
Mónica Antoñanzas Basa
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncología Medica
Principal Investigator Name
Angel Artal Cortes
Principal Investigator Email
aartalc@salud.aragon.es
Contact Person Name
Angel Artal Cortes
Contact Person Email
aartalc@salud.aragon.es
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Servicio Oncologia
Principal Investigator Name
Noelia Vilarino Quintela
Principal Investigator Email
nvilarino@iconcologia.net
Contact Person Name
Noelia Vilarino Quintela
Contact Person Email
nvilarino@iconcologia.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Oncología
Principal Investigator Name
Luis Angel Leon Mateos
Principal Investigator Email
luis.angel.leon.mateos@sergas.es
Contact Person Name
Luis Angel Leon Mateos
Site Name
Hospital Universitario De Jaen
Department Name
Oncología Medica
Principal Investigator Name
Ana Laura Ortega Granados
Principal Investigator Email
analauraortega@gmail.com
Contact Person Name
Ana Laura Ortega Granados
Contact Person Email
analauraortega@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
29
Number Of Sites
10
Number Of Participants
47

Sites

Site Name
Pratia Onkologia Katowice
Principal Investigator Name
Kamil Wdowiak
Principal Investigator Email
wdowiak.kamil@op.pl
Contact Person Name
Kamil Wdowiak
Contact Person Email
wdowiak.kamil@op.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Principal Investigator Name
Barbara Radecka
Principal Investigator Email
brad@onkologia.opole.pl
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Kliniczny Oddział Pneumologii,Onkologii i Alergologi
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
izachm@wp.pl
Contact Person Name
Izabela Chmielewska
Contact Person Email
izachm@wp.pl
Site Name
Radomskie Centrum Onkologii
Department Name
Kliniczny Oddział Chemioterapii
Principal Investigator Name
Mariusz Korzeniowski
Principal Investigator Email
mariusz121221@wp.pl
Contact Person Name
Mariusz Korzeniowski
Contact Person Email
mariusz121221@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Odział Onkologii Klinicznej
Principal Investigator Name
Jacek Kabut
Principal Investigator Email
jkabut@uck.katowice.pl
Contact Person Name
Jacek Kabut
Contact Person Email
jkabut@uck.katowice.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Magdalena Ciazynska
Principal Investigator Email
ciazynska.magdalena@gmail.com
Contact Person Name
Magdalena Ciazynska
Contact Person Email
ciazynska.magdalena@gmail.com
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Kilinka Onkologii Klinicznej
Principal Investigator Name
Tomasz Kucharczyk
Principal Investigator Email
tomaszkucharczyk73@wp.pl
Contact Person Name
Tomasz Kucharczyk
Contact Person Email
tomaszkucharczyk73@wp.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Odział Onkologii Klinicznej
Principal Investigator Name
Bozena Cybulska-Stopa
Principal Investigator Email
bozena.cybulska@dcopih.pl
Contact Person Name
Bozena Cybulska-Stopa
Contact Person Email
bozena.cybulska@dcopih.pl
Site Name
Instytut Msf Sp. z o.o.
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
ewakalinka@wp.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Pratia MCM Krakow
Principal Investigator Name
Anna Drosik-Kwaśniewska
Principal Investigator Email
adrosik-kwasniewska@pratia.com
Contact Person Name
Anna Drosik-Kwaśniewska
Contact Person Email
adrosik-kwasniewska@pratia.com

Hungary

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
28
Number Of Sites
9
Number Of Participants
37

Sites

Site Name
Farkasgyepui Tudogyogyintezet
Department Name
I Pulmonologia
Principal Investigator Name
Zsolt Kiraly
Principal Investigator Email
igazgatas@farkasgyepukorhaz.hu
Contact Person Name
Zsolt Kiraly
Contact Person Email
igazgatas@farkasgyepukorhaz.hu
Site Name
University Of Pecs
Department Name
Onkoterapias Intezet
Principal Investigator Name
Arpad Boronkai
Principal Investigator Email
arpad.boronkai@gmail.com
Contact Person Name
Arpad Boronkai
Contact Person Email
arpad.boronkai@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiologiai Kozpont
Principal Investigator Name
Judit Kocsis
Principal Investigator Email
kocsisjucidr@gmail.com
Contact Person Name
Judit Kocsis
Contact Person Email
kocsisjucidr@gmail.com
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkopulmonológiai Járóbeteg Centrum
Principal Investigator Name
Gabriella Galffy
Principal Investigator Email
galffy.gabriella@torokbalintkorhaz.hu
Contact Person Name
Gabriella Galffy
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Tudogyogyaszati Onkologiai Gondozo
Principal Investigator Name
Nora Bittner
Principal Investigator Email
nora_bittner@yahoo.ca
Contact Person Name
Nora Bittner
Contact Person Email
nora_bittner@yahoo.ca
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Tudogyogyaszat Osztaly
Principal Investigator Name
Ibolya Laczo
Principal Investigator Email
laczo.ibolya@bmkk.eu
Contact Person Name
Ibolya Laczo
Contact Person Email
laczo.ibolya@bmkk.eu
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Varmegyei Onkologiai Kozpont
Principal Investigator Name
Zsuzsanna Orosz
Principal Investigator Email
onkologia@hetenyikorhaz.hu
Contact Person Name
Zsuzsanna Orosz
Contact Person Email
onkologia@hetenyikorhaz.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Onkologiai Centrum
Principal Investigator Name
Eva Somogyine Ezer
Principal Investigator Email
ezer.eva@kmmk.hu
Contact Person Name
Eva Somogyine Ezer
Contact Person Email
ezer.eva@kmmk.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz (duplicate listing avoided)
Department Name
Tudogyogyaszati Onkologiai Gondozo
Principal Investigator Name
Nora Bittner
Principal Investigator Email
nora_bittner@yahoo.ca
Contact Person Name
Nora Bittner
Contact Person Email
nora_bittner@yahoo.ca

France

Earliest CTIS Part Ii Submission Date
16-03-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
8
Number Of Sites
8
Number Of Participants
59

Sites

Site Name
CHRU De Nancy
Department Name
Pneumology (study is conducted at Rue de Morvan)
Principal Investigator Name
Bertrand Mennecier
Principal Investigator Email
b.mennecier@chru-nancy.fr
Contact Person Name
Bertrand Mennecier
Contact Person Email
b.mennecier@chru-nancy.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Unité d’Oncologie Thoracique et Cutanee
Principal Investigator Name
Thomas Egenod
Principal Investigator Email
thomas.egenod@chu-limoges.fr
Contact Person Name
Thomas Egenod
Contact Person Email
thomas.egenod@chu-limoges.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Principal Investigator Name
David Planchard
Principal Investigator Email
david.planchard@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Assistance Publique Hopitaux De Paris (Paris, Faubourg St Jacques)
Department Name
Service de Pneumologie - Unité Oncologie Thoracique
Principal Investigator Name
Marie Wislez
Principal Investigator Email
marie.wislez@aphp.fr
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris, Rue Leblanc)
Department Name
Department of Thoracic Oncology
Principal Investigator Name
Elizabeth Fabre
Principal Investigator Email
Elizabeth.fabre@aphp.fr
Contact Person Name
Elizabeth Fabre
Contact Person Email
Elizabeth.fabre@aphp.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Principal Investigator Name
Frederic Bigot
Principal Investigator Email
frederic.bigot@ico.unicancer.fr
Contact Person Name
Frederic Bigot
Site Name
Fondation Hopital Saint Joseph
Department Name
Pneumo-oncology and Allergology Départment
Principal Investigator Name
Charles Naltet
Principal Investigator Email
cnaltet@ghpsj.fr
Contact Person Name
Charles Naltet
Contact Person Email
cnaltet@ghpsj.fr
Site Name
Hopital Ambroise Pare
Department Name
Department of Respiratory Diseases and Thoracic Oncology
Principal Investigator Name
Etienne Giroux Leprieur
Principal Investigator Email
etienne.giroux-leprieur@aphp.fr
Contact Person Name
Etienne Giroux Leprieur

Germany

Earliest CTIS Part Ii Submission Date
12-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
18
Number Of Sites
17
Number Of Participants
42

Sites

Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Fachklinik Löwenstein
Principal Investigator Name
Jonas Kuon
Principal Investigator Email
jonas.kuon@slk-kliniken.de
Contact Person Name
Jonas Kuon
Contact Person Email
jonas.kuon@slk-kliniken.de
Site Name
Klinikum Kassel GmbH
Department Name
Clinic for Hematology, Oncology and Immunology
Principal Investigator Name
Daniela Dörfel
Principal Investigator Email
daniela.doerfel@gnh.net
Contact Person Name
Daniela Dörfel
Contact Person Email
daniela.doerfel@gnh.net
Site Name
Kliniken Maria Hilf GmbH Moenchengladbach
Department Name
Klinik für Hämatologie, Onkologie und Gastroenterologie
Principal Investigator Name
Ullrich Graeven
Principal Investigator Email
ullrich.graeven@mariahilf.de
Contact Person Name
Ullrich Graeven
Contact Person Email
ullrich.graeven@mariahilf.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Dep. of Thoracic Oncology
Principal Investigator Name
Martin Reck
Principal Investigator Email
m.reck@lungenclinic.de
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Clinic for internal medicine II
Principal Investigator Name
Miriam Moeller
Principal Investigator Email
miriam.moeller@martha-maria.de
Contact Person Name
Miriam Moeller
Contact Person Email
miriam.moeller@martha-maria.de
Site Name
Klinikum Aschaffenburg-Alzenau gGmbH
Department Name
Zweigpraxis für Hämatologie und Onkologie/Med. Klinik IV Klinikum Aschaffenburg
Principal Investigator Name
Manfred Welslau
Principal Investigator Email
manfred.welslau@mvz-klinikum-ab.de
Contact Person Name
Manfred Welslau
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Pneumologie
Principal Investigator Name
Sabine Bohnet
Principal Investigator Email
sabine.bohnet@uksh.de
Contact Person Name
Sabine Bohnet
Contact Person Email
sabine.bohnet@uksh.de
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
2. Medizinische Klinik
Principal Investigator Name
Dagmar Täuscher
Principal Investigator Email
taeuscher.studienzentrum.wkg@srh.de
Contact Person Name
Dagmar Täuscher
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik für Pneumologie, Lungenklinik Heckeshorn
Principal Investigator Name
Daniel Misch
Principal Investigator Email
daniel.misch@helios-gesundheit.de
Contact Person Name
Daniel Misch
Site Name
LMU Klinikum Muenchen AöR
Department Name
Respiratory Medicine
Principal Investigator Name
Amanda Tufman
Principal Investigator Email
amanda.tufman@med.uni-muenchen.de
Contact Person Name
Amanda Tufman
Site Name
Kliniken Suedostbayern AG
Department Name
Hematology - Oncology - Palliative medicine
Principal Investigator Name
Thomas Kubin
Principal Investigator Email
thomas.kubin@kliniken-sob.de
Contact Person Name
Thomas Kubin
Contact Person Email
thomas.kubin@kliniken-sob.de
Site Name
Franziskus Hospital Harderberg
Department Name
Thoracic Oncology
Principal Investigator Name
Petra Hoffknecht
Principal Investigator Email
petra.hoffknecht@niels-stensen-kliniken.de
Contact Person Name
Petra Hoffknecht
Site Name
Klinikum Chemnitz gGmbH
Department Name
Innere Medizin IV
Principal Investigator Name
Stefan Hammerschmidt
Principal Investigator Email
s.hammerschmidt@skc.de
Contact Person Name
Stefan Hammerschmidt
Contact Person Email
s.hammerschmidt@skc.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Klink für Onkologie und Hämatologie
Principal Investigator Name
Thorsten Goetze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten Goetze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Internal Medicine II, Department of Pneumology
Principal Investigator Name
Gerlinde Schmidtke-Schrezenmeier
Contact Person Name
Gerlinde Schmidtke-Schrezenmeier
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
Klinik für Onkologie, Hämatologie und Palliativmedizin
Principal Investigator Name
Stefanie Groepper
Principal Investigator Email
stefanie.groepper@vkkd-kliniken.de
Contact Person Name
Stefanie Groepper
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Center for Pneumology and Thoracic surgery
Principal Investigator Name
Karsten Schulmann
Principal Investigator Email
karsten.schulmann@lkhemer.de
Contact Person Name
Karsten Schulmann
Contact Person Email
karsten.schulmann@lkhemer.de

Italy

Earliest CTIS Part Ii Submission Date
30-01-2026
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
55
Number Of Sites
15
Number Of Participants
28

Sites

Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
S.O.C. Oncologia medica e dei Tumori Immonocorrelati
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Medical Oncology and Hematology Unit
Principal Investigator Name
Alessandro Russo
Principal Investigator Email
alessandro.russo@humanitascatania.it
Contact Person Name
Alessandro Russo
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Department of Medical Oncology
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Clinica Sperimentale Testa‑Collo, Torace e Apparato Gastroenterico
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Toracica
Principal Investigator Name
Ilaria Attili
Principal Investigator Email
ilaria.attili@ieo.it
Contact Person Name
Ilaria Attili
Contact Person Email
ilaria.attili@ieo.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology Unit
Principal Investigator Name
Chiara Bennati
Principal Investigator Email
chiara.bennati@auslromagna.it
Contact Person Name
Chiara Bennati
Contact Person Email
chiara.bennati@auslromagna.it
Site Name
IRCCS Azienda Ospedaliera Metropolitana (Genoa)
Department Name
UO Clinica di Oncologia Medica
Principal Investigator Name
Carlo Genova
Principal Investigator Email
carlo.genova@hsanmartino.it
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncologia Medica
Principal Investigator Name
Salvatore Grisanti
Principal Investigator Email
grisanti.salvatore@gmail.com
Contact Person Name
Salvatore Grisanti
Contact Person Email
grisanti.salvatore@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology Department
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Clinica Sperimentale Toraco Polmonare
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SODc Oncologia Clinica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncologia Medica
Principal Investigator Name
Sara Pilotto
Principal Investigator Email
sara.pilotto@univr.it
Contact Person Name
Sara Pilotto
Contact Person Email
sara.pilotto@univr.it
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Onco-Hematology
Principal Investigator Name
Rita Chiari
Principal Investigator Email
rita.chiari@sanita.marche.it
Contact Person Name
Rita Chiari
Contact Person Email
rita.chiari@sanita.marche.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UOC Oncologia Medica
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
UOC Oncologia Medica
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@fbf-isola.it
Contact Person Name
Emilio Bria
Contact Person Email
emilio.bria@fbf-isola.it

Greece

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
120
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department Internal Medicine & Laboratory
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Metropolitan Hospital
Department Name
4th Oncology Department
Principal Investigator Name
Helena Linardou
Principal Investigator Email
elinardou@icloud.com
Contact Person Name
Helena Linardou
Contact Person Email
elinardou@icloud.com
Site Name
University General Hospital Of Heraklion
Department Name
Department of medical oncology
Principal Investigator Name
Sofia Agelaki
Principal Investigator Email
agelaki@uoc.gr
Contact Person Name
Sofia Agelaki
Contact Person Email
agelaki@uoc.gr
Site Name
Athens Medical Center S.A.
Department Name
International Oncology Center/Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Dept. & Clinical Trials Unit
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
7th Oncology Department
Principal Investigator Name
Panagiotis Katsaounis
Principal Investigator Email
pkatsaounis.clinicaltrials@yahoo.com
Contact Person Name
Panagiotis Katsaounis
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
kotsakisthan@gmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com
Site Name
Metropolitan Hospital (Cholargos/Leoforos Mesogeion)
Department Name
4th Oncology Dept./Clinical Trials Unit
Principal Investigator Name
Panagiotis Katsaounis
Principal Investigator Email
pkatsaounis.clinicaltrials@yahoo.com
Contact Person Name
Panagiotis Katsaounis

Sponsor

Primary sponsor

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

Contract research organisations

Name
Iqvia Biotech LLC
Responsibilities
Electronic COA Support Services
Name
ICON Laboratory Services, Inc.
Name
PPD Development LP
Name
Clario
Responsibilities
Medical Imaging - Central Reader
Name
QPS LLC

Third parties

  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Electronic COA Support Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"ICON Laboratory Services, Inc.","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Medical Imaging - Central Reader","organisation_type":"Industry"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PF-08634404
Active Substance
PF-08634404
Modality
Bispecific Antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
PEMETREXED
Active Substance
Pemetrexed
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
CARBOPLATIN
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
PACLITAXEL
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
PACLITAXEL ALBUMIN-BOUND
Active Substance
Paclitaxel albumin-bound
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
SODIUM CHLORIDE
Active Substance
Sodium chloride
Modality
Other
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
PEMBROLIZUMAB
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Combination Treatment
Yes

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