Clinical trial • Phase II • Oncology

CEMIPLIMAB, FIANLIMAB for Non-small cell lung cancer

Phase II trial of CEMIPLIMAB, FIANLIMAB 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 | Small molecule

Key dates

Initial CTIS Submission Date
25-07-2024
First CTIS Authorization Date
06-11-2024

Trial design

Randomised, arm a: placebo + cemiplimab + platinum doublet chemotherapy; arm b: fianlimab high dose + cemiplimab + platinum doublet chemotherapy; arm c: fianlimab low dose + cemiplimab + platinum doublet chemotherapy-controlled Phase II trial in Romania, Spain, France and others.

Randomised
Yes
Comparator
Arm A: placebo + cemiplimab + platinum doublet chemotherapy; Arm B: fianlimab high dose + cemiplimab + platinum doublet chemotherapy; Arm C: fianlimab low dose + cemiplimab + platinum doublet chemotherapy
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
99

Eligibility

Recruits 99 No vulnerable population selected (isVulnerablePopulationSelected: false); trial enrols adult patients only; informed consent is handled using provided subject information and informed consent form documents..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false); trial enrols adult patients only; informed consent is handled using provided subject information and informed consent form documents.

Inclusion criteria

  • {"criterion_text":"- Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8"}
  • {"criterion_text":"- For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol"}
  • {"criterion_text":"- All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol"}
  • {"criterion_text":"- A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
  • {"criterion_text":"- Adequate bone marrow, hepatic and kidney function as defined in the protocol"}
  • {"criterion_text":"- Other protocol-defined Inclusion Criteria apply"}

Exclusion criteria

  • {"criterion_text":"- Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol"}
  • {"criterion_text":"- Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol"}
  • {"criterion_text":"- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol"}
  • {"criterion_text":"- Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed."}
  • {"criterion_text":"- Patients with a history of myocarditis"}
  • {"criterion_text":"- Other protocol-defined Exclusion Criteria apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples","definition_or_measurement_approach":"Evaluated by blinded independent pathological review (BIPR) of post-treatment resected tumor samples"}

Secondary endpoints

  • {"endpoint_text":"- Event-Free Survival (EFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Major pathological response (MPR) by BIPR in post-treatment resected tumor samples","definition_or_measurement_approach":"Assessed by blinded independent pathological review (BIPR) in post-treatment resected tumor samples"}
  • {"endpoint_text":"- MPR by local pathology review in post-treatment resected tumor samples","definition_or_measurement_approach":"Assessed by local pathology review in post-treatment resected tumor samples"}
  • {"endpoint_text":"- Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment","definition_or_measurement_approach":"Measured per RECIST 1.1 by investigator assessment"}
  • {"endpoint_text":"- Occurrence of Adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of Treatment-emergent adverse event (TEAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of Serious adverse events (SAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of Adverse events of special interest (AESIs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of immune-mediated adverse events (imAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of interruption and discontinuation of study drug(s) due to TEAE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of laboratory abnormalities - Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests","definition_or_measurement_approach":"Laboratory abnormalities graded per NCI-CTCAE v5.0 (Grade ≥3)"}
  • {"endpoint_text":"- Occurrence of death due to TEAE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Concentrations of cemiplimab in serum","definition_or_measurement_approach":"Pharmacokinetic serum concentration measurements"}
  • {"endpoint_text":"- Concentrations of fianlimab in serum","definition_or_measurement_approach":"Pharmacokinetic serum concentration measurements"}
  • {"endpoint_text":"- Anti-drug antibodies (ADA) to fianlimab in serum over time","definition_or_measurement_approach":"Immunogenicity assessment (ADA) over time"}
  • {"endpoint_text":"- ADA to cemiplimab in serum over time","definition_or_measurement_approach":"Immunogenicity assessment (ADA) over time"}
  • {"endpoint_text":"- Percentage of patients with definitive surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of patients with cancelled surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of patients with delayed surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Completeness of resection (R0, R1, R2, Rx)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Length in delay of surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Median length of hospital stay","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of peri operative AE associated with surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of peri operative SAE associated with surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of post operative AE associated with surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of post operative SAE associated with surgery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall change in patient-reported global health status/QoL per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Assessed by EORTC QLQ-C30"}
  • {"endpoint_text":"- Overall change in patient-reported physical functioning per EORTC QLQ-C30","definition_or_measurement_approach":"Assessed by EORTC QLQ-C30"}
  • {"endpoint_text":"- Overall change in patient-reported role functioning per EORTC QLQ-C30","definition_or_measurement_approach":"Assessed by EORTC QLQ-C30"}
  • {"endpoint_text":"- Overall change in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)","definition_or_measurement_approach":"Assessed by EORTC QLQ-LC13"}
  • {"endpoint_text":"- Overall change in patient-reported dyspnea per EORTC QLQ-LC13","definition_or_measurement_approach":"Assessed by EORTC QLQ-LC13"}
  • {"endpoint_text":"- Overall change in patient-reported cough per EORTC QLQ-LC13","definition_or_measurement_approach":"Assessed by EORTC QLQ-LC13"}
  • {"endpoint_text":"- Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13","definition_or_measurement_approach":"Assessed by EORTC QLQ-LC13 composite score"}
  • {"endpoint_text":"- Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index","definition_or_measurement_approach":"Assessed by EQ-5D-5L index"}
  • {"endpoint_text":"- Change in patient-reported general health status per Visual analogue scale (VAS) scores","definition_or_measurement_approach":"Assessed by VAS scores"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-C30"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-C30"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-C30"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-LC13"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-LC13"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-LC13"}
  • {"endpoint_text":"- Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13","definition_or_measurement_approach":"Time-to-event using EORTC QLQ-LC13 composite"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
99
Recruitment Window Months
53
Consent Approach
Informed consent obtained from adult participants using provided Subject Information and Informed Consent Form documents (multiple ICF templates present: Main, PGx, Pregnant Partner, FBR). ICFs and supporting materials are available in multiple languages/translations as submitted; consent is provided by the participant (no paediatric assent described).

Methods

  • Posters (site posters) - patient-facing recruitment material
  • Patient email outreach
  • Website / programmatic pages / online clinical trial tiles
  • Study brochure, welcome guide, recruitment leaflet
  • Dr-to-Dr letters and referral fact cards
  • Centralised recruitment and retention support via external vendors (e.g., Clariness GmbH, We Are Couch Limited, WCG Clinical Inc.)

Geography

Total Number Of Sites
65
Total Number Of Participants
103

Romania

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
06-08-2025
Processing Time Days
350
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
Cardiomed S.R.L.
Department Name
Secţia Oncologie Medicală
Contact Person Name
Calin Ioan Cainap
Contact Person Email
office@cardiomedcluj.ro
Site Name
Memorial Healthcare International S.R.L.
Department Name
Secţia Oncologie Medicală
Contact Person Name
Ingrid Adriana Iordan
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Secţia Oncologie Medicală
Contact Person Name
Mihaela Trif
Contact Person Email
secretariat@scjucluj.ro
Site Name
Oncomed S.R.L.
Department Name
Secţia Oncologie Medicală
Contact Person Name
Mihaela Maria Pasca Fenesan
Contact Person Email
office@oncohelp.ro
Site Name
Medisprof S.R.L.
Department Name
Secţia Oncologie Medicală
Contact Person Name
Adrian Anghel Udrea
Contact Person Email
studiiclinice@medisprof.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncologie Medicala II
Contact Person Name
Aurelia Alexandru
Contact Person Email
Secretariat@iob.ro
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Secţia Oncologie Medicală
Contact Person Name
Roxana Ioana Scheusan
Contact Person Email
office@oncocenter.ro

Spain

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
551
Number Of Sites
19
Number Of Participants
23

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Contact Person Name
Javier Valdivia Bautista
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Silverio Ros Martinez
Contact Person Email
silverio.ros@carm.es
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Hugo Arasanz Esteban
Site Name
University Hospital Son Espases
Department Name
Oncology
Contact Person Name
Aitor Azkarate Martinez
Contact Person Email
aitor.azkarate@ssib.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Francisco de Asis Aparisi Aparisi
Contact Person Email
Aparisi_fraapa@gva.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Joaquim Bosch Barrera
Contact Person Email
jbosch@iconcologia.net
Site Name
Hospital General Universitario De Elche
Department Name
Oncology
Contact Person Name
Javier David Benítez Fuentes
Contact Person Email
oncologia_elx@gva.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Luis Ángel Leon Mateos
Site Name
Hospital Alvaro Cunqueiro
Department Name
Oncology
Contact Person Name
Martín Lázaro Quintela
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Contact Person Name
Emilio Esteban González
Contact Person Email
eestebang@seom.org
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Contact Person Name
Roxana Maribel Reyes Cabanillas
Contact Person Email
rreyes@oncorosell.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
ssandiego@fivo.org
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Contact Person Name
Blanca Isabel Tavara Silva
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Manuel Domine Gomez
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Jon Zugazagoitia Fraile
Contact Person Email
j.zugazagoitia.imas12@h12o.es
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Oncology
Contact Person Name
Silvia Catot Tort
Contact Person Email
scatot@althaia.cat
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
Maria Gonzalez Cao
Contact Person Email
mgonzalezcao@oncorosell.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Contact Person Name
José Fuentes Pradera

France

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
541
Number Of Sites
10
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service des maladies respiratoires
Contact Person Name
Maeva Zysman
Contact Person Email
maeva.zysman@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Département de Pneumologie
Contact Person Name
Ayoub Zouak
Contact Person Email
ayoube.zouak@chu-dijon.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Institut de Cancérologie de l’Ouest Saint Herblain
Contact Person Name
Ludovic Doucet
Site Name
Hopitaux Prives De Metz
Department Name
Département de Pneumologie
Contact Person Name
Lucile Roussel
Contact Person Email
Lucile.roussel@uneos.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Contact Person Name
Thomas Egenod
Contact Person Email
thomas.egenod@chu-limoges.fr
Site Name
Medipole De Nancy
Department Name
ILC Centre d’Oncologie de Gentilly
Contact Person Name
Laurene Gavoille
Contact Person Email
l.gavoille@ilcgroupe.fr
Site Name
Assistance Publique Hopitaux De Paris (Boulogne-Billancourt)
Department Name
Département des maladies respiratoires et d’oncologie médicale
Contact Person Name
Etienne Giroux-Leprieur
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
Service de Pneumologie-Unité d’Oncologie Thoracique
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Département d’Oncologie Médicale
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Département de Pneumologie
Contact Person Name
Christos Chouaid
Contact Person Email
christos.chouaid@chicreteil.fr

Italy

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
547
Number Of Sites
21
Number Of Participants
24

Sites

Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncologia, P.O. “Santa Maria della Misericordia”
Contact Person Name
Marianna Macerelli
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
U.O. Oncologia Medica Via Giuseppe Taverna 49, Piacenza, 29121
Contact Person Name
Elena Zaffigani
Contact Person Email
e.zaffignani@ausl.pc.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica per la Patologia Toracica
Contact Person Name
Michele Montrone
Contact Person Email
m.montrone@oncologico.bari.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Oncologia Falck, Niguarda Cancer Center
Contact Person Name
Elio Gregory Pizzutilo
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Contact Person Name
Gloria Borra
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
DH Oncologico
Contact Person Name
Stefano Panni
Contact Person Email
stefano.panni@asst-cremona.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Oncologia
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
S.O.C. Oncologia medica e dei tumori immuno-correlati
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
UOC Oncologia, Stabilimenti: S.Salvatore Muraglia Pesaro - S.Salvatore Centrale Pesaro-S.Croce Fano
Contact Person Name
Rita Chiari
Contact Person Email
rita.chiari@sanita.marche.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Oncologia Via della Commenda, 19, 20122 Milano Italy
Contact Person Name
Claudia Maria Regina Bareggi
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Oncology Department - SD Oncopneumologia
Contact Person Name
Iacopo Petrini
Contact Person Email
iacopo.petrini@unipi.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Medica Toraco-Polmonare
Contact Person Name
Francesco Morabito
Site Name
Centro Di Riferimento Oncologico Di Aviano (other listing)
Department Name
S.O.C. Oncologia medica e dei tumori immuno-correlati
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Department Name
S.C. Oncologia
Contact Person Name
Pier Luigi Piovano
Contact Person Email
plpiovano@ospedale.al.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
SC. Oncologia
Contact Person Name
Anna Bettini
Contact Person Email
abettini@asst-pg23.it
Site Name
Careggi University Hospital
Department Name
SODc Oncologia Clinica
Contact Person Name
Lorenzo Antonuzzo
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia medica 2, IRCCS Istituto Nazionale Tumori Regina Elena
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
U.O.C. Oncoematologia
Contact Person Name
Carminia Maria Della Corte
Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica – Ospedale Civile Livorno
Contact Person Name
Giacomo Allegrini

Germany

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
547
Number Of Sites
8
Number Of Participants
36

Sites

Site Name
Lungenfachklinik Immenhausen
Department Name
Pneumologische Onkologie, thorakale Onkologie, Immuntherapie
Contact Person Name
Achim Rittmeyer
Site Name
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Contact Person Name
Lars Galonska
Contact Person Email
l.galonska@ak-neuss.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Internistische Onkologie/Hämatologie mit Integrierter Palliativmedizin
Contact Person Name
Sebastian Ertl
Contact Person Email
studiensekretariat@kem-med.com
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Thoraxzentrum Hamburg-Lungenabteilung
Contact Person Name
Claas Wesseler
Contact Person Email
c.wesseler@asklepios.com
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV-Organonkologie
Contact Person Name
Thomas Wehler
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Onkologie
Contact Person Name
Karsten Schulmann
Contact Person Email
karsten.schulmann@lkhemer.de
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Recruitment materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Pathology Lab","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"We Are Couch Limited","duties_or_roles":"Recruitment and Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA and IRT","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"eCOA translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Recruitment and Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Speciality Lab","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Cemiplimab & Fianlimab - 2
Active Substance
CEMIPLIMAB, FIANLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Cemiplimab and Fianlimab - 1
Active Substance
CEMIPLIMAB, FIANLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
LIBTAYO 350 mg concentrate for solution for infusion.
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
prodAuthStatus: 2; marketingAuthNumber: EU/1/19/1376/001
Maximum Dose
350 mg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.