Clinical trial • Phase II • Oncology

GSK6097608 for Non-small cell lung cancer

Phase II trial of GSK6097608 for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
26-04-2024
First CTIS Authorization Date
11-06-2024

Trial design

Randomised, open-label, keytruda (pembrolizumab) 25 mg/ml concentrate for solution for infusion - dose/schedule not specified-controlled, adaptive Phase II trial in Belgium, Finland, France and others.

Randomised
Yes
Open Label
Yes
Comparator
KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion - dose/schedule not specified
Adaptive
True, Platform study utilising a master protocol with participants randomized in a varying ratio into combination or monotherapy arms; specific dose-escalation rules, interim analyses or stopping rules are not provided in the record.
Biomarker Stratified
True, PD-L1 (TC/TPS >=50%)
Target Sample Size
166
Trial Duration For Participant
1111

Eligibility

Recruits 166 No vulnerable population selected. Participants must be at least 18 years old (or legal age of consent in the jurisdiction) and be capable of giving signed informed consent as described in the protocol. Consent is obtained via a signed ICF; multiple language ICFs and specific ICF modules (e.g., optional biopsy, genetic research, treatment beyond progression, rechallenge/restart) are available. Documents for legal representatives/holders of parental authority and provisions for oral witness are present in the documentation, but the trial enrols adults only..

Pregnancy Exclusion
A woman of childbearing potential (WOCBP) must not be pregnant; this will generally be confirmed via a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.
Vulnerable Population
No vulnerable population selected. Participants must be at least 18 years old (or legal age of consent in the jurisdiction) and be capable of giving signed informed consent as described in the protocol. Consent is obtained via a signed ICF; multiple language ICFs and specific ICF modules (e.g., optional biopsy, genetic research, treatment beyond progression, rechallenge/restart) are available. Documents for legal representatives/holders of parental authority and provisions for oral witness are present in the documentation, but the trial enrols adults only.

Inclusion criteria

  • {"criterion_text":"- Is capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n- If of childbearing potential, female participants must be willing to use adequate contraception. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) as defined in the protocol or Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective as described in the protocol during the study intervention period and for at least 4 months after the last dose of study intervention. Female participant agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. A woman of childbearing potential (WOCBP) must not be pregnant; this will generally be confirmed via a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.\n- Is, at the time of signing the ICF, at least 18 years old or the legal age of consent in the jurisdiction in which the study is taking place.\n- Has a histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or nonsquamous). Mixed tumors will be categorized by the predominant cell type; if small-cell or neuroendocrine elements are present, the participant is ineligible.\n- Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.\n- Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC. Although a fresh tumor tissue sample obtained during screening is preferred, an archival tumor specimen (collected within 2 years prior to screening*) is acceptable. Tumor tissue must be from a site not previously irradiated. Biopsies obtained prior to the administration of any systemic therapy administered for the treatment of a participant’s tumor (such as neoadjuvant/adjuvant therapy) are not acceptable. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable, nor are bone specimens.\n- Has a PD-L1-high (TC/TPS >/=50%) tumor.\n- Has measurable disease based on RECIST 1.1 as determined by the investigator.\n- Has an ECOG PS of 0 or 1.\n- Has adequate organ function as defined in the protocol"}

Exclusion criteria

  • {"criterion_text":"- Has NSCLC with a tumor that harbors any of the following molecular alterations: a. EGFR mutations that are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19, exon 20 insertion mutation, and exon 21 [L858R] substitution mutation). All participants with nonsquamous histology must have been tested for EGFR mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for EGFR mutation status. Participants with nonsquamous histology and unknown or indeterminate EGFR status are excluded. b. ALK translocations that are sensitive to available targeted inhibitor therapy. All participants with nonsquamous histology must have been tested for ALK fusion mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for ALK mutation status. Participants with nonsquamous histology and with unknown or indeterminate ALK status are excluded. c. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.\n- Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.\n- Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis, paracentesis, or pericardiocentesis) is eligible if the participant otherwise meets entry criteria.\n- Has active inflammatory bowel disease, acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis.\n- Has a history or evidence of cardiac abnormalities, including: a. Recent history (i.e., within 6 months prior to the first dose of study intervention) of any of the following: i. Serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second-degree (Type II) or third-degree AV block (including complete heart block). ii. Myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, bypass grafting, or newly diagnosed cardiomyopathy. iii. Symptomatic pericarditis. b. Congestive heart failure (Class III or IV) as defined by the New York Heart Association Functional Classification System [The Criteria Committee of the New York Heart Association, 1994]. c. Myocarditis of any grade.\n- Has QTcF >470 msec, or >480 msec for participants with bundle branch block.\n- Has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n- Has had a severe infection requiring IV antibiotics or requiring hospitalization for infection or complication of infection or has had severe pneumonia within 4 weeks prior to the first dose of study intervention.\n- Has active tuberculosis.\n- Has a known HIV infection.\n- Has a history of severe hypersensitivity to mAbs or to any of the excipients in the formulations of the components of the study interventions\n- Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30 Gy (for any purpose, including palliatively) within 6 months prior to the first dose of study intervention.\n- Has any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric, or other condition that could, in the opinion of the investigator, interfere with participant’s safety, obtaining informed consent, or compliance with the study procedures\n- Is, at the time of signing the ICF, a regular user (including recreational use) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol) that, in the opinion of the investigator, would interfere with the evaluation of the study intervention or interpretation of safety.\n- Has a positive test for the presence of HBsAg at Screening or within 3 months prior to first dose of study intervention.\n- Has a positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention. NOTE: Participants with a positive hepatitis C antibody test due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.\n- Has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention. NOTE: Participants with a negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.\n- Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications\n- Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention.\n- Has a history of allogeneic tissue/stem cell transplant or solid organ transplant\n- Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other checkpoint pathways.\n- Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime\n- Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below: a. Participants may be enrolled in the study with a history of any other invasive malignancy for which the participant was definitively treated, from which the participant has been disease-free for at least 2 years, and which, in the opinion of the principal investigator and sponsor/medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted malignancy. b. Participants with curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled in the study.\n- Has known brain metastases meeting any of the following criteria: a. Symptomatic b. Untreated (NOTE: asymptomatic brain metastases are exclusionary if untreated) c. Actively progressing d. Any leptomeningeal disease (regardless of symptomatology, treatment status, or stability). NOTE: Participants with non-leptomeningeal brain metastases who have received prior therapy for brain metastases and have radiographically stable CNS disease for at least 4 weeks (confirmed by 2 brain scans taken at least 4 weeks apart, with at least 1 scan collected after treatment of brain metastases) may participate, provided they are neurologically stable for at least 2 weeks following treatment for brain metastases (i.e., any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved) and prior to the first dose of study intervention. Corticosteroids must be discontinued at least 3 days prior to the first dose of study intervention.\n- Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. Replacement therapies (e.g., insulin, thyroxine, or physiologic doses of corticosteroids for treatment of adrenal or pituitary insufficiency) are not considered systemic treatments and are allowed.\n- Has received systemic steroid therapy </=3 days prior to the first dose of study intervention or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Note the following: a. Corticosteroid use is allowed as premedication for hypersensitivity reactions (e.g., IV contrast allergies/reactions). b. Use of topical, inhaled, or intranasal corticosteroids, local steroid injection, or steroid eye drops is allowed. c. Participants who receive daily steroid replacement therapy are an exception to this criterion. Daily prednisone at doses of ≤10 mg is an example of replacement therapy. Equivalent hydrocortisone doses are also permitted if administered as a replacement therapy.\n- Has received any live vaccine within 30 days prior to first dose of study intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of TEAEs and SAEs Incidence of TEAEs/SAEs leading to dose modifications (e.g., dose delay) or study intervention discontinuation","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
166
Recruitment Window Months
48
Consent Approach
Participants must provide signed informed consent (ICF) and be at least 18 years old or the legal age of consent in the jurisdiction. The protocol requires capacity to give signed informed consent. Multiple language ICFs and subject information documents are provided (English, French, German, Spanish, Italian, Dutch, Polish, Portuguese, Greek, Hungarian, Finnish and others as per available D4/D1 documents). Optional consent modules cover optional biopsy, genetic research/PGx, treatment beyond progression, rechallenge, restart and pre-screening. Documents for legal representatives, holders of parental authority and oral witness are available in the documentation set for relevant jurisdictions.

Geography

Total Number Of Sites
61
Total Number Of Participants
174

Belgium

Latest Decision Or Authorization Date
17-11-2025
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
University Of Antwerp
Department Name
Thoracic Oncology
Principal Investigator Name
Reinier Wener
Principal Investigator Email
oncotrials@uza.be
Contact Person Name
Reinier Wener
Contact Person Email
oncotrials@uza.be

Finland

Latest Decision Or Authorization Date
11-11-2025
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Pirkanmaan hyvinvointialue
Department Name
Department of Oncology
Principal Investigator Name
Jarkko Ahvonen
Principal Investigator Email
kirjaamo@pirha.fi
Contact Person Name
Jarkko Ahvonen
Contact Person Email
kirjaamo@pirha.fi
Site Name
Vaasa Central Hospital
Department Name
Department of Oncology
Principal Investigator Name
Antti Jekunen
Principal Investigator Email
etunimi.sukunimi@ovph.fi
Contact Person Name
Antti Jekunen
Contact Person Email
etunimi.sukunimi@ovph.fi
Site Name
Oulu University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Jussi Koivunen
Principal Investigator Email
etunimi.sukunimi@pohde.fi
Contact Person Name
Jussi Koivunen
Contact Person Email
etunimi.sukunimi@pohde.fi
Site Name
Turku University Hospital
Department Name
Tyks T-hospital
Principal Investigator Name
Maria Silvoniemi
Principal Investigator Email
etunimi.sukunimi@varha.fi
Contact Person Name
Maria Silvoniemi
Contact Person Email
etunimi.sukunimi@varha.fi

France

Latest Decision Or Authorization Date
14-11-2025
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Institut Bergonie
Department Name
Departement of Medical Oncology
Principal Investigator Name
Sophie Cousin
Principal Investigator Email
s.cousin@bordeaux.unicancer.fr
Contact Person Name
Sophie Cousin
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Nouvel Hôpital Civil - Service Pneumologie
Principal Investigator Name
Céline Mascaux
Principal Investigator Email
celine.mascaux@chru-strasbourg.fr
Contact Person Name
Céline Mascaux
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Pneumologie
Principal Investigator Name
Simon Deshayes
Principal Investigator Email
deshayes-si@chu-caen.fr
Contact Person Name
Simon Deshayes
Contact Person Email
deshayes-si@chu-caen.fr
Site Name
Institut Paoli Calmettes
Department Name
Departement of Medical Oncology
Principal Investigator Name
Philippe Rochigneux
Principal Investigator Email
rochigneuxp@ipc.unicancer.fr
Contact Person Name
Philippe Rochigneux
Contact Person Email
rochigneuxp@ipc.unicancer.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Département d'Oncologie Médicale
Principal Investigator Name
Romain Corre
Principal Investigator Email
romain.corre@ch-cornouaille.fr
Contact Person Name
Romain Corre
Contact Person Email
romain.corre@ch-cornouaille.fr

Germany

Latest Decision Or Authorization Date
17-11-2025
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Christian Grohé
Principal Investigator Email
christian.grohe@jsd.de
Contact Person Name
Christian Grohé
Contact Person Email
christian.grohe@jsd.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik (Tumorforschung)
Principal Investigator Name
Martin Schuler
Principal Investigator Email
Martin.Schuler@uk-essen.de
Contact Person Name
Martin Schuler
Contact Person Email
Martin.Schuler@uk-essen.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik fuer Innere Medizin 2
Principal Investigator Name
Friedrich Jakob Hammersen
Principal Investigator Email
jakob.hammersen@med.uni-jena.de
Contact Person Name
Friedrich Jakob Hammersen
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie
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
Technische Universitaet Dresden
Department Name
Medizinische Fakultät Carl Gustav Carus
Principal Investigator Name
Martin Wermke
Principal Investigator Email
martin.wermke@uniklinikum-dresden.de
Contact Person Name
Martin Wermke
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxonkologie
Principal Investigator Name
Michael Thomas
Principal Investigator Email
michael.thomas@med.uni-heidelberg.de
Contact Person Name
Michael Thomas

Greece

Latest Decision Or Authorization Date
11-11-2025
Number Of Sites
7
Number Of Participants
22

Sites

Site Name
Athens Medical Center S.A.
Department Name
Oncology Clinic
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd University of Department of Internal Medicine
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
Alexandra Hospital
Department Name
Athens Medical School - Therapeutic Clinic
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Internal Medicine Clinic
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
psyrri237@yahoo.com
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic AUTH
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Unit
Principal Investigator Name
Eleni Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com

Italy

Latest Decision Or Authorization Date
11-11-2025
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica
Principal Investigator Name
Giacomo Allegrini
Principal Investigator Email
giacomo.allegrini@uslnordovest.toscana.it
Contact Person Name
Giacomo Allegrini
Site Name
Careggi University Hospital
Department Name
S.O.D. Radioterapia
Principal Investigator Name
Lorenzo Livi
Principal Investigator Email
lorenzo.livi@unifi.it
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Cesare Gridelli
Principal Investigator Email
cgridelli@libero.it
Contact Person Name
Cesare Gridelli
Contact Person Email
cgridelli@libero.it
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
UO Oncologia Medica
Principal Investigator Name
Chiara Matilde Catania
Principal Investigator Email
chiara.catania@gavazzeni.it
Contact Person Name
Chiara Matilde Catania
Contact Person Email
chiara.catania@gavazzeni.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
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 Ulss 9 Scaligera
Department Name
Oncologia Medica
Principal Investigator Name
Paolo Piacentini
Principal Investigator Email
paolo.piacentini@aulss9.veneto.it
Contact Person Name
Paolo Piacentini

Netherlands

Latest Decision Or Authorization Date
17-11-2025
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
St. Antonius Ziekenhuis
Department Name
Lung oncology
Principal Investigator Name
Elisabeth A Lisanne Kastelijn
Principal Investigator Email
rdlongoncologie@antoniusziekenhuis.nl
Contact Person Name
Elisabeth A Lisanne Kastelijn
Site Name
Medisch Spectrum Twente
Department Name
Pulmonary Diseases
Principal Investigator Name
Emanuel Citgez
Principal Investigator Email
Onderzoeksbureau.Longgeneeskunde@mst.nl
Contact Person Name
Emanuel Citgez
Site Name
Stichting Martini Ziekenhuis
Department Name
Wetenschappelijk Instituut
Principal Investigator Name
Jan Willem Gerrit van Putten
Principal Investigator Email
wetenschap@mzh.nl
Contact Person Name
Jan Willem Gerrit van Putten
Contact Person Email
wetenschap@mzh.nl
Site Name
Frisius MC
Department Name
Oncologisch Centrum Leeuwarden
Principal Investigator Name
Rolof G.P. Gijtenbeek
Principal Investigator Email
trialverpleegkundigen.ocl@mcl.nl
Contact Person Name
Rolof G.P. Gijtenbeek

Poland

Latest Decision Or Authorization Date
18-11-2025
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii
Principal Investigator Name
Marta Czeluścińska-Murawiec
Principal Investigator Email
onkologia@szpital.siedlce.pl
Contact Person Name
Marta Czeluścińska-Murawiec
Contact Person Email
onkologia@szpital.siedlce.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Onkologii Klinicznej VII
Principal Investigator Name
Krzysztof Rogoziewicz
Principal Investigator Email
krzysztof.rogoziewicz@dcopih.pl
Contact Person Name
Krzysztof Rogoziewicz
Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oddział Pulmonologii
Principal Investigator Name
Anna Łowczak
Principal Investigator Email
pulomonologia@szpitalprabuty.pl
Contact Person Name
Anna Łowczak
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Kliniczny Oddział Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorób Wewnętrznych
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
oddzial.pulmonologii@spsk4.lublin.pl
Contact Person Name
Izabela Chmielewska

Portugal

Latest Decision Or Authorization Date
11-11-2025
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Oncologia
Principal Investigator Name
João Godinho
Principal Investigator Email
joao.batista.godinho@hospitaldaluz.pt
Contact Person Name
João Godinho
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Oncologia
Principal Investigator Name
Encarnação Teixeira
Principal Investigator Email
maria.encarnacao.teixeira@jmellosaude.pt
Contact Person Name
Encarnação Teixeira
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Oncologia
Principal Investigator Name
Margarida Dias
Principal Investigator Email
margarida.pinho.dias@chvng.min-saude.pt
Contact Person Name
Margarida Dias
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Pneumologia
Principal Investigator Name
Pedro Brito
Contact Person Name
Pedro Brito
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncologia Médica
Principal Investigator Name
Marta Soares
Principal Investigator Email
martasoares@ipoporto.min-saude.pt
Contact Person Name
Marta Soares

Spain

Latest Decision Or Authorization Date
17-11-2025
Number Of Sites
12
Number Of Participants
24

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncología
Principal Investigator Name
Enric Carcereny Costa
Principal Investigator Email
ecarcereny@iconcologia.net
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncología
Principal Investigator Name
Óscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Óscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncología
Principal Investigator Name
Sergio Sandiego Contreras
Principal Investigator Email
ssandiego@fivo.org
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
ssandiego@fivo.org
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncología
Principal Investigator Name
Delvys Rodríguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvys Rodríguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncología
Principal Investigator Name
Belén Rubio Viqueira
Principal Investigator Email
belen.rubio@quironsalud.es
Contact Person Name
Belén Rubio Viqueira
Contact Person Email
belen.rubio@quironsalud.es
Site Name
Hospital Universitario De Badajoz
Department Name
Oncología
Principal Investigator Name
Marta González Cordero
Principal Investigator Email
martagcordero@gmail.com
Contact Person Name
Marta González Cordero
Contact Person Email
martagcordero@gmail.com
Site Name
Institut Catala D'oncologia (L'hospitalet)
Department Name
Oncología
Principal Investigator Name
Ernesto Samuel Nadal Alforja
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernesto Samuel Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Clinica Universidad De Navarra
Department Name
Oncología
Principal Investigator Name
Gonzalo Fernández Hinojal
Principal Investigator Email
gfernandezh@unav.es
Contact Person Name
Gonzalo Fernández Hinojal
Contact Person Email
gfernandezh@unav.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
estudios.clinicos@ibima.eu
Contact Person Name
Manuel Cobo Dols
Contact Person Email
estudios.clinicos@ibima.eu
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
Luis Paz Ares
Principal Investigator Email
lpazaresr@seom.org
Contact Person Name
Luis Paz Ares
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario La Paz
Department Name
Oncología
Principal Investigator Name
Javier de Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier de Castro Carpeño
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
enriqueta.felip@vallhebron.cat
Contact Person Name
Enriqueta Felip Font
Contact Person Email
enriqueta.felip@vallhebron.cat

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
CRO outsourced to manage few countries (HUN, POR & UAE)
Name
PPD Global Limited
Responsibilities
Clinical Supplies
Name
Icon Public Limited Company
Name
IQVIA Rds Inc.
Responsibilities
ePRO
Name
Sermes CRO
Responsibilities
Payment fee reimbursement
Name
Trial Form Support S.L.
Responsibilities
Site Coordination Services, including data management

Third parties

  • {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"CRO outsourced to manage few countries (HUN, POR & UAE)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Raptis Lab","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"ISTOTYPOS IKE","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Trial Form Support S.L.","duties_or_roles":"Site Coordination Services, including data management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"Patient reported outcome","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"European Organisation For Research And Treatment Of Cancer","duties_or_roles":"Patient reported outcome","organisation_type":"Patient organisation/association"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Payment fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"Clinical Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Reimbursement of patient fees","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Diagnostika Ergastiria Parafesta","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient reported outcome","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Theodoros Xionis","duties_or_roles":"private doctor (cardiologist)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"ePRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Propath (UK) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Roylance Stability Storage Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Eurofins Adme Bioanalyses","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"Supply of clinical study equipment (e.g. thermometers, fridges, centrifuges)","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Vendor to manage the patient travel (taxi etc.) reimbursement.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
GSK6097608
Active Substance
GSK6097608
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Investigational
Investigational Product Name
JEMPERLI 500 mg concentrate for solution for infusion
Active Substance
DOSTARLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised (EU/1/21/1538/001)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised (EU/1/15/1024/002)
Investigational Product Name
GSK4428859
Active Substance
HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST TIGIT
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Investigational
Combination Treatment
Yes

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