Clinical trial • Phase I/II • Oncology

TISLELIZUMAB for Small cell lung cancer (extensive stage)

Phase I/II trial of TISLELIZUMAB for Small cell lung cancer (extensive stage).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer (extensive stage)
Trial Stage
Phase I/II
Drug Modality
Radiopharmaceutical|Small molecule|Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
02-08-2024
First CTIS Authorization Date
02-09-2024

Trial design

Randomised, control arm: standard of care consisting of carboplatin, etoposide, and atezolizumab (dose and schedule not specified in the available record), adaptive Phase I/II trial across 29 sites in Netherlands, Germany, Belgium and others.

Randomised
Yes
Comparator
Control arm: standard of care consisting of carboplatin, etoposide, and atezolizumab (dose and schedule not specified in the available record)
Adaptive
True - Phase Ib is a dose-finding (dose-escalation) design to establish the recommended dose of [177Lu]Lu-DOTA-TATE with a backfill cohort; adaptive element is dose escalation/dose finding.
Biomarker Stratified
True - biomarker: SSTR expression assessed by [68Ga]Ga-DOTA-TATE PET; eligibility requires uptake equal or higher than liver (uptake intensity score 2 or above)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
52

Eligibility

Recruits 52 Vulnerable population flag is selected. Participants must be adults (≥18 years) and provide informed consent prior to participation. Study documentation includes main ICFs and specific follow-up information for pregnant participants and partners in multiple country/language versions (e.g. follow-up for pregnant participant, follow-up for pregnant partner, pregnancy follow up parent/legal guardian documents). No assent procedures for minors are described in the available records..

Vulnerable Population
Vulnerable population flag is selected. Participants must be adults (≥18 years) and provide informed consent prior to participation. Study documentation includes main ICFs and specific follow-up information for pregnant participants and partners in multiple country/language versions (e.g. follow-up for pregnant participant, follow-up for pregnant partner, pregnancy follow up parent/legal guardian documents). No assent procedures for minors are described in the available records.

Inclusion criteria

  • {"criterion_text":"- Participant is ≥ 18 years on the day of signing informed consent form\n- Histologically or cytologically confirmed ES-SCLC\n- Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan\n- SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake equal or higher than the liver uptake (uptake intensity score 2 or above in the visual uptake scoring scale) in at least one target or non-target lesion\n- No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period)\n- Provision of tumor tissue to support exploratory biomarker analysis\n- Life expectancy of >=6 months"}

Exclusion criteria

  • {"criterion_text":"- Participant has received prior therapy with an antibody or drug against immune checkpoint pathways\n- Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n- Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 2 Day 1\n- History of current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study\n- Known hypersensitivity to the active substances or any of the excipients of the study drugs\n- Concurrent participation in another therapeutic clinical study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase Ib: • Frequency of dose limiting toxicities (DLTs), incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation\n- Phase II: • Overall Survival (OS) defined as time from date of randomization to death due to any cause","definition_or_measurement_approach":"Phase Ib endpoints measured as frequency/incidence of DLTs, AEs, SAEs and treatment discontinuations (safety/tolerability). Phase II primary endpoint OS defined and measured as time from date of randomization to death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- Phase Ib:•ORR,DOR,PFS,OS\n- Phase Ib:•TACs\n- Phase Ib:•Absorbed radiation doses of [177Lu]Lu-DOTA-TATE in organs and tumor lesions\n- Phase Ib:•Concentration of [177Lu]Lu-DOTA-TATE in blood over time and derived PK parameters\n- Phase Ib:•Quantification of [177Lu]Lu-DOTA-TATE excreted from the body in urine\n- Phase II:•PFS,ORR,DOR based on investigator assessment as per RECIST 1.1\n- Phase Ib and Phase II:•Incidence and severity of AEs and SAEs\n- Phase Ib and Phase II:•Incidence and severity of AEs and SAEs within 48 hours after [68Ga]Ga-DOTA-TATE infusion","definition_or_measurement_approach":"ORR, DOR, PFS, OS per standard oncology definitions; Phase II PFS/ORR/DOR based on investigator assessment per RECIST 1.1. PK/dosimetry endpoints measured by blood concentration over time and absorbed radiation dose quantification; AE/SAE incidence and severity assessed by standard safety reporting, including events within 48 hours after [68Ga]Ga-DOTA-TATE infusion."}

Recruitment

Planned Sample Size
52
Recruitment Window Months
82
Consent Approach
Informed consent must be obtained prior to any study participation. Participants (adults ≥18 years) sign the main ICF. Country-specific ICFs and related documents are provided in multiple languages (examples present for Dutch, German, English, French, Spanish, Italian, Czech). Separate data protection consent and partner/female partner information sheets and pregnancy follow-up consent materials are included. No assent procedures for minors are described.

Geography

Total Number Of Sites
29
Total Number Of Participants
86

Netherlands

Latest Decision Or Authorization Date
27-05-2025
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Meander Medisch Centrum
Department Name
1900: Lung diseases
Contact Person Name
Gerarda Herder
Contact Person Email
GJM.Herder@meandermc.nl
Site Name
St. Antonius Ziekenhuis
Department Name
1901: Lung diseases
Contact Person Name
Lisanne Kastelijn

Germany

Latest Decision Or Authorization Date
04-09-2024
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
University Hospital Cologne AöR
Department Name
2001: Klinik und Poliklinik für Nuklearmedizin
Contact Person Name
Alexander Drzezga
Contact Person Email
Alexander.Drzezga@uk-koeln.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
2000: Klinik für Nuklearmedizin
Contact Person Name
Ken Herrmann
Contact Person Email
Ken.herrmann@uk-essen.de

Belgium

Latest Decision Or Authorization Date
15-05-2025
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
1500:Pulmonary Medicine – Thoracic Oncology
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
1501: Nuclear medicine
Contact Person Name
Nadia Withofs
Contact Person Email
nwithofs@chuliege.be

Italy

Latest Decision Or Authorization Date
12-05-2025
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
2102:SC Medicina Nucleare
Contact Person Name
Marco Maccauro
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
2101:UOSD Sperim. Cliniche: Fase I e Med. Precisione
Contact Person Name
Lorenza Landi
Contact Person Email
lorenza.landi@ifo.gov.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
2100:Medicina Nucleare
Contact Person Name
Alessandro Morabito

France

Latest Decision Or Authorization Date
18-10-2024
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Institut Gustave Roussy
Department Name
#1000: Oncologie médicale
Contact Person Name
David PLANCHARD
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
#1001: Pneumologie
Contact Person Name
Alexis CORTOT
Contact Person Email
Alexis.cortot@chru-lille.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
#1003: Médecine Nucléaire
Contact Person Name
David TAIEB
Contact Person Email
David.taieb@ap-hm.fr
Site Name
Hospices Civils De Lyon (Bron)
Department Name
#1004: Pneumologie
Contact Person Name
Michael DURUISSEAUX
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
#1005: Oncologie médicale
Contact Person Name
Alexandre LUGAT
Contact Person Email
alexandre.lugat@chu-nantes.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
#1002: Pneumologie onco-thoracique
Contact Person Name
Xavier QUANTIN
Site Name
Hospices Civils De Lyon (Pierre Benite)
Department Name
#1004: Pneumologie
Contact Person Name
Michael DURUISSEAUX
Site Name
Centre Hospitalier Universitaire De Nantes (Saint Herblain)
Department Name
#1005: Oncologie médicale
Contact Person Name
Alexandre LUGAT
Contact Person Email
alexandre.lugat@chu-nantes.fr

Spain

Latest Decision Or Authorization Date
02-09-2024
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
3000:Oncología
Contact Person Name
Luis Paz Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Clinico San Carlos
Department Name
3006: Oncología
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Clinic De Barcelona
Department Name
3004:oncología
Contact Person Name
Laura Mezquita Perez
Contact Person Email
mezquita@clinic.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
3003:Oncología
Contact Person Name
Vanessa Gutierrez Calderon
Contact Person Email
vanesa_gutierrez78@hotmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
3005: Oncología
Contact Person Name
Alejandro Olivares Hernández
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
3001 :Oncología Médica
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
3002 :Oncología
Contact Person Name
Pedro Filipe Simoes da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Clinic De Barcelona (additional site entry)
Department Name
3004:oncología

Austria

Latest Decision Or Authorization Date
11-06-2025
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Medical University Of Vienna
Department Name
Department of internal medicine I
Contact Person Name
Markus Raderer
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of internal medicine 4
Contact Person Name
David Lang
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of internal medicine V
Contact Person Name
Arno Amann
Contact Person Email
arno.amann@tirol-kliniken.at

Czechia

Latest Decision Or Authorization Date
10-06-2025
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
University Hospital Olomouc
Department Name
1700: Onkologická klinika
Contact Person Name
Hana Študentová
Contact Person Email
Hana.studentova@fnol.cz

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties codes: [1,3]
Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties codes: [12]
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1]
Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: [1]

Third parties

  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1,3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Advanced Accelerator Applications Iberica S.L.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Advanced Accelerator Applications Molecular Imaging Iberica S.L.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Saale-Apotheke Dr. Christian Wegner e.Kfm.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Fundacion General De La Universidad De Malaga","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Patient organisation/association"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties codes: [14,15] (value: Drug distribution, storage, relabeling, return and destruction)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"sponsorDuties codes: [15] (value: Imaging)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Tevimbra 100 mg concentrate for solution for infusion
Active Substance
TISLELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
EU/1/23/1758/001
Investigational Product Name
NETSPOT
Active Substance
DOTATATE
Modality
Radiopharmaceutical
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Orphan Designation
Yes
Investigational Product Name
Lutathera 370 MBq/mL solution for infusion
Active Substance
LUTETIUM (177LU) OXODOTREOTIDE
Modality
Radiopharmaceutical
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
EU/1/17/1226/001
Orphan Designation
Yes
Combination Treatment
Yes

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