Clinical trial • Phase III • Oncology

ZIMBERELIMAB for Non-small cell lung cancer | Metastatic non-small cell lung cancer

Phase III trial of ZIMBERELIMAB for Non-small cell lung cancer | Metastatic non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Metastatic non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
20-06-2024
First CTIS Authorization Date
17-07-2024

Trial design

Randomised, open-label, pembrolizumab (keytruda) in combination with chemotherapy (comparator arm: pembrolizumab with chemotherapy agents listed in the protocol such as carboplatin, cisplatin, pemetrexed, paclitaxel/abraxane). dose and schedule details are not specified in the ctis record.-controlled Phase III trial in Portugal, France, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Pembrolizumab (KEYTRUDA) in combination with chemotherapy (comparator arm: pembrolizumab with chemotherapy agents listed in the protocol such as carboplatin, cisplatin, pemetrexed, paclitaxel/Abraxane). Dose and schedule details are not specified in the CTIS record.
Biomarker Stratified
True, PD-L1 expression (≥ 1% tumor cells [SP263 scoring])
Target Sample Size
398

Eligibility

Recruits 398 Vulnerable population flag is set (isVulnerablePopulationSelected: true). Participants must be 18 years of age or older and able to understand and give written informed consent; consent is obtained via written ICFs. No procedures for assent of minors are described in the CTIS record; ICFs and related documents are provided in country-specific/local languages..

Pregnancy Exclusion
Positive serum pregnancy test or participants who are breastfeeding or have plans to breastfeed during the study period and for the required duration of contraception use after the last dose of study drug
Vulnerable Population
Vulnerable population flag is set (isVulnerablePopulationSelected: true). Participants must be 18 years of age or older and able to understand and give written informed consent; consent is obtained via written ICFs. No procedures for assent of minors are described in the CTIS record; ICFs and related documents are provided in country-specific/local languages.

Inclusion criteria

  • {"criterion_text":"- Members of all genders, races, and ethnic groups are eligible for this study. Participants must meet all the following inclusion criteria to be eligible for participation in this study (no waivers for participant eligibility will be permitted).\n- Provide adequate tumor tissue from locations not radiated prior to biopsy to allow central evaluation of PD-L1 expression using the investigational VENTANA PD-L1 (SP263) assay prior to randomization. Bone biopsies, cytology, and fine needle aspirates are not suitable tissues. If no tissue is available, a new biopsy will need to be obtained prior to enrollment in the study (Section 6.3.9).\n- ‌Have not received prior systemic treatment for metastatic NSCLC. Participants who received chemotherapy for nonmetastatic disease are eligible if the treatment was completed at least 12 months prior to the start of study treatment.\n- ‌Measurable disease per RECIST v1.1 criteria by investigator assessment (Appendix 7). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n- ‌ECOG performance status score of 0 or 1.\n- see protocol for organ function requirement.\n- Participants assigned male at birth and participants assigned female at birth of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception from screening visit until 6 months after the last dose of chemotherapy and 120 days after the last dose of DOM, ZIM, or PEMBRO (or longer according to local regulatory requirements), as described in of the study protocol.\n- Participants assigned male at birth and participants assigned female at birth, 18 years of age or older, able to understand and give written informed consent.\n- Life expectancy ≥ 3 months\n- Pathologically documented NSCLC that meets both criteria below: a) Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on AJCC, Eighth Edition). b) Have documented negative test results for actionable EGFR and ALK mutations and ALK gene rearrangements. Note: tumor testing for actionable EGFR or ALK mutations or ALK gene rearrangements is not required for participants with nonsquamous‌squamous NSCLC tumor histology if status is unknown (Section 6.3.9).\n- ‌Have no actionable genomic alterations such as ROS proto-oncogene 1, neurotrophic tyrosine receptor kinase, proto-oncogene B-raf, RET mutations, or other driver oncogenes with approved frontline therapies. Testing of actionable genomic alterations required by local regulations will be performed locally. Note: see Appendix Table 1 for requirements in Germany and Appendix Table 5 for requirements in Argentina (Appendix 14)."}

Exclusion criteria

  • {"criterion_text":"- Participants who meet any of the following exclusion criteria at screening/Day −1 are not eligible to be enrolled in this study (no waivers for participant eligibility will be offered or permitted): Have mixed SCLC and NSCLC histology.\n- ‌Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are not requiring use of steroids for at least 14 days prior to the start of study treatment. All participants with carcinomatous meningitis are excluded regardless of clinical stability.\n- Meet any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication). c) New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction less than 40%.\n- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6 months of enrollment.\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- Has received radiotherapy within 2 weeks prior to first dose of study intervention or radiotherapy to the lung that is > 30 Gy within 6 months of the first study treatment.\n- Has had an allogenic tissue/solid organ transplant.\n- Have received a live virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.\n- Have active infection requiring treatment (eg, antibiotics).\n- Have known history of HIV-1 or 2 with uncontrolled viral load (ie, ≥ 200 copies/mL or CD4+ T-cell count < 350 cells/μL), or taking medications that may interfere with metabolism of study drugs. No HIV testing is required unless mandated by local health authority.\n- Have known acute hepatitis B, known chronic hepatitis B infection with active untreated disease, or known active hepatitis C infection. In participants with a history of hepatitis B virus or hepatitis C virus, participants with detectable viral loads will be excluded. No hepatitis testing is required unless mandated by local health authority.\n- Positive serum pregnancy test or participants who are breastfeeding or have plans to breastfeed during the study period and for the required duration of contraception use after the last dose of study drug\n- Have other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n- Received prior treatment with any anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, or any other antibody targeting an immune checkpoint. Participants who received programmed cell death protein 1/programmed cell death ligand ‌PD-1/PD-L1 inhibitors as a part of treatment for early stage or locally advanced stage NSCLC are not eligible.\n- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.\n- Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.6.3 of the protocol\n- Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment. Participants with a history of malignancy that has been completely treated, with no evidence of active cancer for at least 3 years prior to enrollment, or with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n- ‌Have an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n- ‌Are receiving chronic systemic steroids (> 10 mg/day prednisone equivalent). Use of topical, inhalational, intranasal, and intraocular steroids will be permitted. ‌\n- ‌Have significant third-space fluid retention (eg, ascites or pleural effusion) and is not amenable for required repeated drainage."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- OS is defined as the time from the date of randomization to the date of death from any cause (both in participants with positive PD-L1 expression [≥ 1% TC] and in all randomized participants as dual primary endpoints)","definition_or_measurement_approach":"Overall survival (OS): time from randomization to date of death from any cause; dual primary endpoints are OS in participants with PD-L1 ≥ 1% TC (SP263 scoring) and OS in all randomized participants."}

Secondary endpoints

  • {"endpoint_text":"- PFS is defined as the time from the date of randomization until progressive disease (PD) as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first.\n- ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by BICR according to RECIST v1.1\n- DOR is defined as the time from the first response (CR or PR), to the first documented PD, as assessed by BICR according to RECIST v1.1, or death from any cause, whichever comes first.\n- Incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities\n- Time to first symptom deterioration in NSCLC SAQ shortness of breath domain\n- Time to first deterioration in NSCLC-SAQ total score","definition_or_measurement_approach":"PFS: time from randomization to PD per blinded independent central review (BICR) per RECIST v1.1 or death. ORR: proportion with CR or PR confirmed ≥4 weeks later by BICR per RECIST v1.1. DOR: time from first CR/PR to documented PD by BICR per RECIST v1.1 or death. TEAEs: incidence, severity, seriousness and relatedness assessed per safety reporting. NSCLC-SAQ endpoints: time-to-event patient-reported outcome measures (as specified: shortness of breath domain and total score)."}

Recruitment

Planned Sample Size
398
Recruitment Window Months
57
Consent Approach
Written informed consent obtained from each participant (participants must be ≥18 years and able to understand and give written informed consent). No assent for minors is described. Country- and language-specific ICFs are provided (examples in Portuguese, French, German, Spanish, Dutch, Italian, English as indicated by document lists). Optional/partner/secondary consent forms (eg, genomic substudy, partner pregnancy follow-up, optional future research, treatment-beyond-progression) are available as separate ICF documents.

Methods

  • Country-specific recruitment arrangements documents (K1) published for multiple member states describing local recruitment processes.
  • Doctor-to-doctor letters (K2) to inform referring physicians about the trial (country-specific doctor-to-doctor letters present).
  • Site patient advocacy contact lists / patient-advocacy contact resources (documented for some countries).
  • Patient-facing materials including patient card and participant ICFs for distribution at sites.

Geography

Total Number Of Sites
70
Total Number Of Participants
322

Portugal

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
18-07-2024
Processing Time Days
13
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Oncology
Principal Investigator Name
Michelle Silva
Principal Investigator Email
michelle.c.silva@hff.min-saude.pt
Contact Person Name
Michelle Silva
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Pneumology
Principal Investigator Name
Paula Alves
Principal Investigator Email
alvespaula57@gmail.com
Contact Person Name
Paula Alves
Contact Person Email
alvespaula57@gmail.com
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Oncology
Principal Investigator Name
João Moreira Pinto
Principal Investigator Email
joao.ppinto@ulslod.min-saude.pt
Contact Person Name
João Moreira Pinto
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Pneumology
Principal Investigator Name
Telma Sequeira
Principal Investigator Email
tsequeira@ipolisboa.min-saude.pt
Contact Person Name
Telma Sequeira
Site Name
Champalimaud Clinical Centre
Department Name
Oncology
Principal Investigator Name
Patrícia Garrido Maurício
Principal Investigator Email
patricia.garrido@fundacaochampalimaud.pt
Contact Person Name
Patrícia Garrido Maurício
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Oncology
Principal Investigator Name
Fernanda Estevinho
Principal Investigator Email
fernandaestevinho@gmail.com
Contact Person Name
Fernanda Estevinho
Contact Person Email
fernandaestevinho@gmail.com

France

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
18
Number Of Sites
9
Number Of Participants
24

Sites

Site Name
Centre Hospitalier De Saint-Quentin
Principal Investigator Name
Charles Dayen
Principal Investigator Email
c.dayen@ch-stquentin.fr
Contact Person Name
Charles Dayen
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Principal Investigator Name
Clarisse Audigier-Valette
Principal Investigator Email
clarisse.audigier-valette@ch-toulon.fr
Contact Person Name
Clarisse Audigier-Valette
Site Name
Hopital Ambroise Pare
Principal Investigator Name
Etienne Giroux-Leprieur
Principal Investigator Email
etienne.giroux-leprieur@aphp.fr
Contact Person Name
Etienne Giroux-Leprieur
Site Name
Clinique Victor Hugo
Principal Investigator Name
Julien Domont
Principal Investigator Email
essaisdomont@ilcgrope.fr
Contact Person Name
Julien Domont
Contact Person Email
essaisdomont@ilcgrope.fr
Site Name
Centre Hospitalier Regional De Marseille
Principal Investigator Name
Laurent Greillier
Principal Investigator Email
laurent.greillier@ap-hm.fr
Contact Person Name
Laurent Greillier
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
Institut Regional Du Cancer De Montpellier
Principal Investigator Name
Xavier Quantin
Principal Investigator Email
xavier.quantin@icm.unicancer.fr
Contact Person Name
Xavier Quantin
Site Name
Direction Centrale Du Service De Sante Des Armees
Principal Investigator Name
Hugo Picchi
Principal Investigator Email
picchi.hugo90@gmail.com
Contact Person Name
Hugo Picchi
Contact Person Email
picchi.hugo90@gmail.com
Site Name
Hospital Foch
Principal Investigator Name
Hélène Doubre
Principal Investigator Email
h.doubre@hopital-foch.org
Contact Person Name
Hélène Doubre
Contact Person Email
h.doubre@hopital-foch.org
Site Name
Institut De Cancerologie De L Ouest
Principal Investigator Name
Judith Raimbourg
Principal Investigator Email
judith.raimbourg@ico.unicancer.fr
Contact Person Name
Judith Raimbourg

Austria

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department of Internal Medicine and Pneumology
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Klinikum Wels-Grieskirchen
Principal Investigator Name
Christian Trockenbacher
Principal Investigator Email
Christian.Trockenbacher@klinikum-wegr.at
Contact Person Name
Christian Trockenbacher
Site Name
Ordensklinikum Linz GmbH
Department Name
department of pneumology
Principal Investigator Name
Michael Schumacher
Principal Investigator Email
michael.schumacher@ordensklinikum.at
Contact Person Name
Michael Schumacher

Belgium

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
14
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Department Oncology
Principal Investigator Name
Jean-Charles Goeminne
Principal Investigator Email
Jean-charles.goeminne@uclouvain.be
Contact Person Name
Jean-Charles Goeminne
Site Name
AZ Sint-Lucas & Volkskliniek
Department Name
Department Pneumology/Respiratory Oncology
Principal Investigator Name
Elke Govaerts
Principal Investigator Email
elke.govaerts@azstlucas.be
Contact Person Name
Elke Govaerts
Contact Person Email
elke.govaerts@azstlucas.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology-Hematology Department
Principal Investigator Name
Benoît Colinet
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Benoît Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Emmaues
Department Name
Department Pneumology/RespiratoryOncology
Principal Investigator Name
Marc Lambrechts
Principal Investigator Email
marc.lambrechts@emmaus.be
Contact Person Name
Marc Lambrechts
Contact Person Email
marc.lambrechts@emmaus.be

Netherlands

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
17
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Longgeneeskunde
Principal Investigator Name
Jeroen Hiltermann
Principal Investigator Email
t.j.n.hiltermann@umcg.nl
Contact Person Name
Jeroen Hiltermann
Contact Person Email
t.j.n.hiltermann@umcg.nl
Site Name
Amphia Hospital
Department Name
Longgeneeskunde
Principal Investigator Name
Kornelis vd Leest
Principal Investigator Email
LeestK@amphia.nl
Contact Person Name
Kornelis vd Leest
Contact Person Email
LeestK@amphia.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Longgeneeskunde
Principal Investigator Name
Jeroen Kloover
Principal Investigator Email
js.kloover@etz.nl
Contact Person Name
Jeroen Kloover
Contact Person Email
js.kloover@etz.nl
Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
longgeneeskunde
Principal Investigator Name
Arthur Mulders
Principal Investigator Email
amulders@zgv.nl
Contact Person Name
Arthur Mulders
Contact Person Email
amulders@zgv.nl
Site Name
Ziekenhuis St Jansdal
Department Name
Longgeneeskunde
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
ln.boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl

Spain

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
12
Number Of Sites
21
Number Of Participants
188

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Reyes Bernabe Caro
Principal Investigator Email
bernabeensayos@gmail.com
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Joaquim Bosch
Principal Investigator Email
jbosch@iconcologia.net
Contact Person Name
Joaquim Bosch
Contact Person Email
jbosch@iconcologia.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Oscar Jose Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital 9 De Octubre S.A.
Department Name
Oncology
Principal Investigator Name
Vicente Guillem Porta
Principal Investigator Email
vguillem@oncomed.es
Contact Person Name
Vicente Guillem Porta
Contact Person Email
vguillem@oncomed.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Laia Vila Martinez
Principal Investigator Email
lvila@tauli.cat
Contact Person Name
Laia Vila Martinez
Contact Person Email
lvila@tauli.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Principal Investigator Name
Margarita Majem Tarruella
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Manuel Domine Gomez
Principal Investigator Email
ensayoscancerpulmonfjd@gmail.com
Contact Person Name
Manuel Domine Gomez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
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 Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Principal Investigator Name
Maria Gonzalez Cao
Principal Investigator Email
mgonzalezcao@oncorosell.com
Contact Person Name
Maria Gonzalez Cao
Contact Person Email
mgonzalezcao@oncorosell.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Principal Investigator Name
David Vicente Baz
Principal Investigator Email
david.vbaz@gmail.com
Contact Person Name
David Vicente Baz
Contact Person Email
david.vbaz@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Isidoro Carlos Barneto Aranda
Principal Investigator Email
isidoroc.barneto@gmail.com
Contact Person Name
Isidoro Carlos Barneto Aranda
Contact Person Email
isidoroc.barneto@gmail.com
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncology
Principal Investigator Name
Miguel Fernandez De Sanmamed Gutierrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitario De Jaen
Department Name
Oncology
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
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology
Principal Investigator Name
Miguel Fernandez De Sanmamed Gutierrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Laura Mezquita Perez
Principal Investigator Email
lmezquita@clinic.cat
Contact Person Name
Laura Mezquita Perez
Contact Person Email
lmezquita@clinic.cat
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
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
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Javier De Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier De Castro Carpeño
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
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
Salut Sant Joan De Reus
Department Name
Oncology
Principal Investigator Name
Clara Lucia Gozalvez
Principal Investigator Email
clara.lucia@salutsantjoan.cat
Contact Person Name
Clara Lucia Gozalvez
Contact Person Email
clara.lucia@salutsantjoan.cat

Germany

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
26-07-2024
Processing Time Days
21
Number Of Sites
12
Number Of Participants
40

Sites

Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Krankenhaus Köln-Merheim / Lungenklinik
Principal Investigator Name
Eva-Lotte Buchmeier
Principal Investigator Email
buchmeiere@kliniken-koeln.de
Contact Person Name
Eva-Lotte Buchmeier
Contact Person Email
buchmeiere@kliniken-koeln.de
Site Name
Katholisches Marienkrankenhaus gGmbH
Department Name
Zentrum für Innere Medizin
Principal Investigator Name
Peter Ebeling
Principal Investigator Email
ebeling.innere@marienkrankenhaus.org
Contact Person Name
Peter Ebeling
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Claas Wesseler
Principal Investigator Email
c.wesseler@asklepios.com
Contact Person Name
Claas Wesseler
Contact Person Email
c.wesseler@asklepios.com
Site Name
Muehlenkreiskliniken AöR
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Parvis Sadjadian
Principal Investigator Email
parvis.sadjadian@muehlenkreiskliniken.de
Contact Person Name
Parvis Sadjadian
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik III – Studienzentrum 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
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Zentrum für Pneumologie und Thoraxchirurgie
Principal Investigator Name
Karsten Schulmann
Principal Investigator Email
karsten.schulmann@lkhemer.de
Contact Person Name
Karsten Schulmann
Contact Person Email
karsten.schulmann@lkhemer.de
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Wolfgang Schütte
Principal Investigator Email
wolfgang.schuette@martha-maria.de
Contact Person Name
Wolfgang Schütte
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
LungenClinic Grosshansdorf GmbH
Department Name
Not applicable
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
Sana Klinikum Offenbach GmbH
Department Name
Medizinische Klinik IV, Hämatologie und internistische Onkologie
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
thomas.wehler@sana.de
Contact Person Name
Thomas Wehler
Contact Person Email
thomas.wehler@sana.de
Site Name
Augusta-Kranken-Anstalt gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Robert Radkowski
Principal Investigator Email
r.radkowski@augusta-bochum.de
Contact Person Name
Robert Radkowski
Contact Person Email
r.radkowski@augusta-bochum.de
Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
Medizinische Klinik 2
Principal Investigator Name
Christian Meyer zum Büschenfelde
Principal Investigator Email
christian.mzb@vincentius-ka.de
Contact Person Name
Christian Meyer zum Büschenfelde
Contact Person Email
christian.mzb@vincentius-ka.de

Italy

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
105
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica A
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
Fondazione IRCCS Policlinico San Matteo
Department Name
Medical Oncology
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
f.agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
UO Oncologia Medica
Principal Investigator Name
Elena Zaffignani
Principal Investigator Email
e.zaffignani@ausl.pc.it
Contact Person Name
Elena Zaffignani
Contact Person Email
e.zaffignani@ausl.pc.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento Di Oncologia
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
IRCCS Ospedale Policlinico San Martino
Department Name
UOS Tumori Polmonari-Oncologia Medica 2
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
AORN San Giuseppe Moscati Avellino
Department Name
Department of Oncology/Ematology
Principal Investigator Name
Cesare Gridelli
Principal Investigator Email
cgridelli@libero.it
Contact Person Name
Cesare Gridelli
Contact Person Email
cgridelli@libero.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Division of Medical Oncology
Principal Investigator Name
Ferdinando Riccardi
Principal Investigator Email
ferdinando.riccardi@aocardarelli.it
Contact Person Name
Ferdinando Riccardi
Site Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Department Name
UOC Oncologia Marche Nord
Principal Investigator Name
Rita Chiari
Principal Investigator Email
rita.chiari@ospedalimarchenord.it
Contact Person Name
Rita Chiari
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
SC Oncologia
Principal Investigator Name
Stefano Panni
Principal Investigator Email
stefano.panni@asst-cremona.it
Contact Person Name
Stefano Panni
Contact Person Email
stefano.panni@asst-cremona.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC di Oncologia Medica
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
alessandra.bearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
alessandra.bearz@cro.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
Signant Health LLC
Responsibilities
Electronic data capture / participant data services (contact provided); sponsor duties code 7
Name
Signant Health Global LLC
Responsibilities
IVRS - Treatment Randomization
Name
Bioclinica Inc.
Responsibilities
ECG analysis/review and medical image analysis/review
Name
PPD France
Responsibilities
Pharmacovigilance and other CRO services including SUSAR reporting and other operational duties
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Routine clinical pathology testing / clinical chemistry
Name
Labcorp Early Development Laboratories Inc.
Responsibilities
Long term storage of samples / biorepository

Third parties

  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Sponsor duties code 7 (unspecified in CTIS record); contact: alejandra.benitez@signanthealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine Clinical Pathology Testing Clinical Chemistry","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS - Treatment Randomization","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG Analysis/Review; Medical Image Analysis/Review - x-ray, MRI, ultrasound, etc; Primary/Surrogate Endpoint Test","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"PPD France","duties_or_roles":"Multiple sponsor duties including code 1, code 12, SUSAR Reporting, code 2 (as listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Long Term Storage of Samples","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Zimberelimab
Active Substance
ZIMBERELIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus 1
Investigational Product Name
DOMVANALIMAB
Active Substance
DOMVANALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus 1
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion (Pembrolizumab)
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus 2; marketing authorisation EU/1/15/1024/002
Combination Treatment
Yes

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