Clinical trial • Phase III • Oncology

TIFCEMALIMAB for Small cell lung cancer (limited stage)

Phase III trial of TIFCEMALIMAB for Small cell lung cancer (limited stage).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer (limited stage)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Monoclonal antibody

Key dates

Initial CTIS Submission Date
04-10-2024
First CTIS Authorization Date
10-02-2025

Trial design

Randomised, placebo arms: arm b = placebo for tifcemalimab (iv) combined with toripalimab (240 mg iv) q3w; arm c = placebos for both tifcemalimab and toripalimab (iv) q3w. (placebo-controlled comparator schedules mirror active dosing schedule q3w.) Phase III trial in France, Italy, Belgium and others.

Randomised
Yes
Comparator
Placebo arms: Arm B = placebo for tifcemalimab (IV) combined with toripalimab (240 mg IV) Q3W; Arm C = placebos for both tifcemalimab and toripalimab (IV) Q3W. (Placebo-controlled comparator schedules mirror active dosing schedule Q3W.)
Target Sample Size
756

Stratification factors

  • Disease stage per AJCC 8th edition: Stage I/II vs. Stage III
  • Prophylactic cranial irradiation (PCI) conducted or planned: yes vs. no
  • Region: Asian countries vs. non-Asian countries

Eligibility

Recruits 756 Vulnerable population flag is selected. Participants must voluntarily sign the informed consent form; inclusion criteria require age ≥ 18 so no assent procedures for minors are specified. Country-specific informed consent forms (ICFs) are provided (multiple language versions listed in documents)..

Pregnancy Exclusion
Women who are pregnant or breastfeeding.
Vulnerable Population
Vulnerable population flag is selected. Participants must voluntarily sign the informed consent form; inclusion criteria require age ≥ 18 so no assent procedures for minors are specified. Country-specific informed consent forms (ICFs) are provided (multiple language versions listed in documents).

Inclusion criteria

  • {"criterion_text":"- Male or female with age ≥ 18 years old at the time of informed consent."}
  • {"criterion_text":"- Histologically / cytologically confirmed limited-stage (Tumor Node Metastasis [TNM] Stage I-III [T any, N any, M0] by AJCC eighth edition) SCLC that can be safely treated with definitive radiation doses. Patients with Stage I or II disease must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery."}
  • {"criterion_text":"- Received concurrent CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-70 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy or radiotherapy (whichever occurs last)."}
  • {"criterion_text":"- Patients must achieve a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed PD prior to study entry"}
  • {"criterion_text":"- Prophylactic cranial irradiation (PCI) is permitted per Investigator’s discretion and local standard of care. PCI can be done prior to study entry or during the treatment period."}
  • {"criterion_text":"- Approximately 5 unstained formalin-fixed, paraffin-embedded serial slides from archival or recently obtained tumour tissue prior to radiotherapy (preferably recently obtained tissues) should be provided for biomarker analysis. Patients who cannot provide adequate tumour tissue samples as described above can only be enrolled after discussion and agreement between the Investigator and the Sponsor."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1"}
  • {"criterion_text":"- Life expectancy ≥ 12 weeks."}
  • {"criterion_text":"- Adequate organ function as defined below (note: blood component transfusions or hematopoietic growth factors are not allowed within 14 days prior to obtaining screening tests); a. Absolute neutrophil count (ANC) ≥ 1.5×109/L; b. Platelets ≥ 100×109/L; c. Haemoglobin ≥ 9 g/dL; d. Bilirubin ≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5×ULN, aspartate aminotransferase (AST) ≤ 2.5×ULN; e. Creatinine clearance ≥ 30 mL/min according to Cockcroft-Gault formula; f. Activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN and international normalized ratio (INR) ≤ 1.5 except for patients on stable doses of anticoagulant therapy, such as low molecular heparin or warfarin, where an INR within the expected therapeutic range of the anticoagulant is acceptable."}
  • {"criterion_text":"- Female patients of childbearing potential and male patients whose partners are women of childbearing age are required to use a medically approved form of highly effective methods of contraception (e.g., intrauterine device, birth control pill, or condom with spermicide) during study treatment and at least 4 months after the last dose of tifcemalimab/placebo or toripalimab/placebo"}
  • {"criterion_text":"- Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures"}

Exclusion criteria

  • {"criterion_text":"- Mixed SCLC and non-small cell lung cancer (NSCLC)."}
  • {"criterion_text":"- More than or less than 4 cycles of chemotherapy during CRT or received a chemotherapy regimen other than intravenous etoposide and a platinum-based regimen."}
  • {"criterion_text":"- Received sequential chemoradiotherapy for LS-SCLC."}
  • {"criterion_text":"- Known allergy or hypersensitivity reaction to any investigational interventions or any investigational intervention excipients."}
  • {"criterion_text":"- Received any of the following treatments. a. Immune-mediated therapy, including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy. b. Any investigational interventions within 4 weeks or 5 half-lives prior to the first dose, whichever is shorter. c. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or the patient is in the follow-up period of an interventional clinical study. d. Systemic corticosteroids >10 mg/day prednisone or its equivalent or other immunosuppressive agents within 2 weeks before the first dose of the investigational intervention. Inhaled or topical use of corticosteroids are permitted. Short courses of corticosteroids (e.g., prior to intravenous contrast) within 2 weeks of the first dose of the investigational intervention are permitted. e. An antineoplastic vaccine or a live vaccine within 4 weeks prior to the first dose of the investigational intervention. f. Major surgery or serious trauma within 4 weeks prior to the first dose of the investigational intervention"}
  • {"criterion_text":"- History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids)."}
  • {"criterion_text":"- Patients with active tuberculosis by medical history or computed tomography (CT) examination, those with a history of treated active tuberculosis within 1 year prior to enrolment, or those with a history of untreated active tuberculosis more than 1 year prior to enrolment."}
  • {"criterion_text":"- The presence of active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method)."}
  • {"criterion_text":"- Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer."}
  • {"criterion_text":"- Women who are pregnant or breastfeeding."}
  • {"criterion_text":"- Uncontrolled co-morbidities, including but not limited to symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) < 50%, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhoea, or psychiatric/social conditions that may compromise study compliance, result in a significantly increased risk of an AE, or affect the patient's ability to provide written consent."}
  • {"criterion_text":"- Patients, as determined by the Investigator, who may have other conditions likely to lead to early study withdrawal, such as other serious diseases (including psychiatric disease) requiring concomitant therapy, prisoners, participants who are involuntarily incarcerated or are expected to perform mandatory military service in the coming years, serious laboratory abnormalities, and/or family or social factors that may compromise patient safety or information collection."}
  • {"criterion_text":"- Individuals who are dependent on the Sponsor, clinical site, or Investigator (e.g., an employee of the Sponsor or a clinical trial site, a dependent of the Investigator, or any site staff members otherwise supervised by the Investigator)."}
  • {"criterion_text":"- Individuals who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, in accordance with local regulations."}
  • {"criterion_text":"- Failure to recover from the toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion/exclusion criteria, whichever is more severe."}
  • {"criterion_text":"- Patients with active autoimmune disease, history of autoimmune disease (including but not limited to interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Patients with vitiligo or childhood asthma/allergies who do not require any intervention in adulthood, patients on a stable dose of thyroid replacement hormone for autoimmune-mediated hypothyroidism, and patients on a stable dose of insulin for Type I diabetes mellitus are eligible for enrolment."}
  • {"criterion_text":"- History of immunodeficiency, including human immunodeficiency virus (HIV) seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation."}
  • {"criterion_text":"- Severe or life-threatening infections (CTCAE Grade > 2) within 4 weeks prior to the first dose of investigational intervention, such as serious pneumonia, bacteraemia, or infectious complications requiring hospitalization; baseline chest imaging suggestive of active pulmonary inflammation; signs and symptoms of infection requiring oral or intravenous antibiotic therapy (except for prophylactic antibiotics) within 2 weeks prior to the first dose of investigational interventions."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS) as stated."}
  • {"endpoint_text":"- BIRC-assessed PFS (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1).","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- Investigator-assessed PFS","definition_or_measurement_approach":"Progression-free survival as assessed by the investigator."}
  • {"endpoint_text":"- 1-year and 2-year OS rates","definition_or_measurement_approach":"Proportion of patients alive at 1 year and 2 years."}
  • {"endpoint_text":"- - Investigator-assessed ORR - Investigator-assessed DCR. - Investigator-assessed DoR.","definition_or_measurement_approach":"Investigator-assessed objective response rate (ORR), disease control rate (DCR), and duration of response (DoR)."}
  • {"endpoint_text":"- - Safety: incidence of AEs, abnormal laboratory parameters. - PK of tifcemalimab and toripalimab: trough concentrations. - Immunogenicity of tifcemalimab and of toripalimab: incidence and titers of anti-drug antibodies (ADAs) and, if ADA positive, neutralizing antibodies (NAbs).","definition_or_measurement_approach":"Safety measured by incidence of adverse events and laboratory abnormalities; pharmacokinetics characterized by trough concentrations; immunogenicity assessed by incidence and titres of ADAs and NAbs when ADA positive."}

Recruitment

Planned Sample Size
756
Recruitment Window Months
56
Consent Approach
Participants (age ≥ 18) must voluntarily sign an informed consent form prior to any study procedures. Country-specific informed consent forms are provided (multiple language versions listed e.g., French, English, Italian, Dutch, Polish, Spanish, Romanian, German). No assent from minors is described since minimum age is 18.

Methods

  • Use of country-specific recruitment brochures and posters (documents listed: e.g., K1_BEL, K1_ITA, K1_DEU, K1_ESP, K1_POL, K1_ROU, K2_NLD) and recruitment procedure descriptions (English/local language) provided for sites.
  • Site-based recruitment via participating hospital/oncology centres (site lists provided in Part II for each country).

Geography

Total Number Of Sites
60
Total Number Of Participants
149

France

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
12-02-2025
Processing Time Days
79
Number Of Sites
13
Number Of Participants
32

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
FRA008: Maladies respiratoires
Contact Person Name
Remi Veillon
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
FRA009: Centre de Coordination en Cancérologie
Contact Person Name
Isabelle Monnet
Contact Person Email
isabelle.monnet@chicreteil.fr
Site Name
Centre Leon Berard
Department Name
FRA007: département d'oncologie médicale
Contact Person Name
Maurice Perol
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
FRA011: Oncologie/Pneumologie
Contact Person Name
Jean-Louis Pujol
Contact Person Email
jl-pujol@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
FRA002: Service Respiratoire, Oncologie thoracique et de soin Intensif respiratoire
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
FRA003: Servce d'Oncologie Médicale
Contact Person Name
Sandrine Hiret
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
FRA006: Pôle Thorax et Vaisseaux – Service de Pneumologie - Unité d’Oncologie Thoracique
Contact Person Name
Denis Moro-Sibilot
Contact Person Email
dmoro-sibilot@chu-grenoble.fr
Site Name
Institut Gustave Roussy
Department Name
FRA013: Département d'hématologiemédecine Oncologique
Contact Person Name
Pernelle LAVAUD
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
FRA012: Pneumology
Contact Person Name
Youssef Oulkhouir
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
FRA005: NA
Contact Person Name
Ivan Toledano
Contact Person Email
toledano@ccgm.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
FRA004: Service de Pneumologie
Contact Person Name
Eric Pichon
Contact Person Email
e.pichon@chu-tours.fr
Site Name
Institut Bergonie
Department Name
FRA001: Service d'Oncologie Médicale
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux (Institut addition)
Department Name
FRA001: Service d'Oncologie Médicale
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr

Italy

Earliest CTIS Part Ii Submission Date
17-12-2024
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
199
Number Of Sites
9
Number Of Participants
33

Sites

Site Name
Istituto Oncologico Veneto
Department Name
ITA009: UOC Oncologia Medica 1
Contact Person Name
Laura Bonanno
Contact Person Email
laura.bonanno@iov.veneto.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
ITA003: UOSD Ematologia e Trapianti
Contact Person Name
Gabriele Minuti
Contact Person Email
gabriele.minuti@gmail.com
Site Name
San Camillo Forlanini Hospital
Department Name
ITA007: Medicina Interna 3
Contact Person Name
Serena Ricciardi
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
ITA002: Attività Integrata di Oncologi
Contact Person Name
Federica Bertolini
Contact Person Email
federica.bertolini@tiscali.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
ITA006: U.O. Oncologia Medica
Contact Person Name
Hector Jose Soto Parra
Contact Person Email
hsotoparra.ctu@gmail.com
Site Name
Careggi University Hospital
Department Name
ITA001: Oncologia Medica 1
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@unifi.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
ITA005: S.C. Oncologia
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
ITA008: Oncologia
Contact Person Name
Ferdinando Riccardi
Contact Person Email
nando.riccardi@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
ITA004: Struttura Semplice Dipartimentale di Oncologia Toracica
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it

Belgium

Earliest CTIS Part Ii Submission Date
17-12-2024
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
202
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
BEL005: Pulmonology
Contact Person Name
Sofie Derijcke
Contact Person Email
sofie.derijcke@azgroeninge.be
Site Name
Grand Hopital De Charleroi
Department Name
BEL003: Oncologie - Hématologie
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Algemeen Ziekenhuis Klina
Department Name
BEL004: Oncologie
Contact Person Name
Wim Demey
Contact Person Email
wim.demey@klina.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
BEL001: Oncology
Contact Person Name
Vincent Vanhaudenarde
Site Name
Jessa Ziekenhuis
Department Name
BEL002: Pneumologie - Thoracale Oncologie
Contact Person Name
Kristof Cuppens
Contact Person Email
Kristof.Cuppens@stzh.be

Romania

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
396
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Oncolab S.R.L.
Department Name
ROU001: Medical oncology
Contact Person Name
Dan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
ROU005: Oncology
Contact Person Name
Andrei UNGUREANU
Site Name
Oncomed S.R.L.
Department Name
ROU002: Medical Oncology
Contact Person Name
Serban Mircea Negru
Contact Person Email
snegru@yahoo.com
Site Name
Medisprof S.R.L.
Department Name
ROU003: Oncology
Contact Person Name
Anghel Adrian UDREA
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
ROU009: Oncology
Contact Person Name
Laurentia Gales
Site Name
Spitalul Clinic Colentina - Pediatric Dermatology
Department Name
ROU007: Pediatric Dermatology
Contact Person Name
Andrei Popescu
Contact Person Email
andreipopescu1983@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
ROU008: Oncology
Contact Person Name
Tudor-Eliade Ciuleanu
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
ROU004: Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca (additional site)
Department Name
ROU006: Oncologie Medicala
Contact Person Name
Alina Simona MUNTEAN
Contact Person Email
muntean.alina@yahoo.fr

Germany

Earliest CTIS Part Ii Submission Date
16-12-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
448
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
DEU005: Klinik für Pneumologie
Contact Person Name
Christian Grohé
Contact Person Email
christian.grohe@jsd.de

Spain

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
415
Number Of Sites
15
Number Of Participants
17

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
ESP009: Oncología Médica
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Quironsalud Malaga
Department Name
ESP018: Oncología
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuel.cobo.co@quironsalud.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
ESP007: Oncología Médica
Contact Person Name
Roxana Reyes
Contact Person Email
rreyes@oncorosell.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
ESP020: Oncología
Contact Person Name
Salvador Gámez Casado
Contact Person Email
sgamez@hmhospitales.com
Site Name
Hospital Universitario De Jaen
Department Name
ESP011:Oncología Médica
Contact Person Name
Ana Laura Ortega Granados
Site Name
Hospital Universitari Vall D Hebron
Department Name
ESP017:Oncología
Contact Person Name
Pedro Filipe Simões Da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
ESP001: Oncología
Contact Person Name
Manuel Dómine Gómez
Contact Person Email
mdomine@fjd.es
Site Name
Hospital Universitario Central De Asturias
Department Name
ESP014:Oncología Médica
Contact Person Name
Noemi Villanueva Palicio
Contact Person Email
noemivipa@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
ESP003: Oncología Médica
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
ESP004: Oncología
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
disla@salud.aragon.es
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
ESP019: Oncología
Contact Person Name
Juan Carlos Quero Guillen
Contact Person Email
jcquerog@seom.org
Site Name
Hospital Universitario La Paz
Department Name
ESP008: Oncología
Contact Person Name
Javier de Castro Carpeño
Site Name
Hospital Universitario Donostia
Department Name
ESP016:Oncología
Contact Person Name
Ibone de Elejoste Echebarria
Site Name
Hospital Universitario Miguel Servet
Department Name
ESP013:Oncología
Contact Person Name
Angel Artal Cortés
Contact Person Email
aartalc@salud.aragon.es
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
ESP002: Oncología Médica
Contact Person Name
Paula Llor Rodriguez
Contact Person Email
paulallorod@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
07-03-2026
Processing Time Days
397
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
POL004: III Klinika Chorob Pluc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
m.polaczek@igichp.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
POL002: II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
Contact Person Name
Robert Mroz
Contact Person Email
robmroz@wp.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
POL003: Klinika Radioterapii
Contact Person Name
Sergiusz Nawrocki
Contact Person Email
sergiusz.nawrocki@gmail.com
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
POL005: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
k.stencel@post.pl

Netherlands

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
420
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Isala Klinieken Stichting
Department Name
NLD003:Polyclinic - Pulmonary Diseases
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
NLD001:Pulmonology
Contact Person Name
Daphne Dumoulin
Contact Person Email
d.dumoulin@erasmusmc.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
NLD002:Pulmonology
Contact Person Name
Bianca van Veggel
Contact Person Email
b.v.veggel@jbz.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
NLD004:Pulmonology
Contact Person Name
Niels Claessens
Contact Person Email
nclaessens@rijnstate.nl

Sponsor

Primary sponsor

Full Name
Shanghai Junshi Biosciences Co. Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
China

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Contract Research Organization (CRO) Services (clinical operations, monitoring, data management and related CRO services as listed).

Third parties

  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"PD-L1 22C3, HVEM IHC testing as well as PK, ADA, Nab analysis; Sample transportation service from investigator sites to Labcorp; Lab kits supply and transportation; Sample storage service.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Provide Medidata Rave EDC system (on-cloud database service for study site users to enter clinical trial data).","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"China","full_name":"Catalent (Shanghai) Clinicl Trial Supplies Co. Ltd.","duties_or_roles":"Clinical drug supply chain services, including packaging labeling, storage, distribution, return and destruction.","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Contract Research Organization (CRO) Services and other CRO responsibilities (codes listed in sponsorDuties).","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Bioclinica Shanghai Co. Ltd.","duties_or_roles":"Conduct central imaging services in compliance with ICH GCP.","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Calyx China Co. Ltd.","duties_or_roles":"Randomisation and trial RT system services including study management, cohort management, patient management and medication management.","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
TAB004
Active Substance
TIFCEMALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
Intravenous
Authorisation Status
Investigational product (PRD9858054, prodAuthStatus:1)
Starting Dose
200 mg IV
Frequency
Once every 3 weeks (Q3W)
Maximum Dose
Max total dose amount: 7000 mg (maxDailyDoseAmount: 200 mg)
Investigational Product Name
Toripalimab
Active Substance
TORIPALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
Intravenous
Authorisation Status
Investigational product (PRD8831688, prodAuthStatus:1)
Starting Dose
240 mg IV
Frequency
Once every 3 weeks (Q3W)
Maximum Dose
Max total dose amount: 8400 mg (maxDailyDoseAmount: 200 mg)
Combination Treatment
Yes

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