Clinical trial • Phase III • Oncology

CARBOPLATIN for Small cell lung cancer | Extensive-stage small cell lung cancer

Phase III trial of CARBOPLATIN for Small cell lung cancer | Extensive-stage small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer | Extensive-stage small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody|Bispecific antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
21-01-2026
First CTIS Authorization Date
12-05-2026

Trial design

Randomised, open-label, obrixtamig in combination with atezolizumab, carboplatin and etoposide versus atezolizumab, carboplatin and etoposide. atezolizumab: 1200 mg fixed dose (as specified); carboplatin: auc 5 (as specified); etoposide: 80-100 mg/m2 (as specified). obrixtamig dose/schedule not specified in available data.-controlled Phase III trial in Belgium, Czechia, Finland and others.

Randomised
Yes
Open Label
Yes
Comparator
Obrixtamig in combination with atezolizumab, carboplatin and etoposide versus atezolizumab, carboplatin and etoposide. Atezolizumab: 1200 mg fixed dose (as specified); Carboplatin: AUC 5 (as specified); Etoposide: 80-100 mg/m2 (as specified). Obrixtamig dose/schedule not specified in available data.
Biomarker Stratified
True, DLL3 (high ≥50% TC)
Target Sample Size
379

Stratification factors

  • DLL3 expression (high ≥50% TC)

Eligibility

Recruits 379 The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Informed consent is required from participants; no specific assent procedures for minors or other vulnerable groups are described in the available documentation..

Vulnerable Population
The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Informed consent is required from participants; no specific assent procedures for minors or other vulnerable groups are described in the available documentation.

Inclusion criteria

  • {"criterion_text":"- 1. Patients with histologically confirmed ES-SCLC who have completed 1 cycle of first-line treatment (platinum, etoposide, with or without anti-PD-1/anti-PD-L1 therapy, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin AUC 5 and etoposide 80 mg/m2).\n- 2. Patients without any previous systematic anti-cancer treatment for ES-SCLC (except for the completed 1 cycle of first-line treatment). Patients who received previous systematic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.\n- 3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of DLL3 expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.\n- 4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria: o Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 14 days prior to randomisation and neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation o Untreated brain metastases that do not require treatment and are neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation.\n- 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n- 6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line SoC treatment within 28 days after the start of the initial cycle of standard therapy.\n- 7. Eligible to receive treatment with full dose of atezolizumab (1200 mg fixed dose), carboplatin (AUC 5), and etoposide (80-100 mg/m2) as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site.\n- 8. Further inclusion criteria apply."}

Exclusion criteria

  • {"criterion_text":"- 1. Presence of leptomeningeal disease and/or carcinomatous meningitis.\n- 2. Previous treatment targeting DLL3 (e.g. TcEs, cell therapies, antibody-drug conjugates, or radiopharmaceuticals).\n- 3. Radiotherapy of any anatomical sites within 14 days prior to randomisation.\n- 4. Persistent toxicity from previous treatments that has not resolved to ≤CTCAE Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment).\n- 5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.\n- 6. Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival.","definition_or_measurement_approach":"Primary objective: \"The primary objective is to demonstrate the superiority in overall survival (OS) in at least 1 of 2 populations: 1) the overall population and 2) the DLL3 high (≥50% TC) population.\""}

Secondary endpoints

  • {"endpoint_text":"- PFS, defined as the time from randomisation until the earliest date of tumour progression according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 based on investigator assessments or death from any cause.","definition_or_measurement_approach":"Defined as time from randomisation to tumour progression per RECIST v1.1 based on investigator assessment or death from any cause; investigator-assessed RECIST 1.1."}
  • {"endpoint_text":"- Change from baseline to Week 19 in the dyspnea symptom subscale of the EORTC QLQ-LC13.","definition_or_measurement_approach":"Change from baseline to Week 19 measured using the EORTC QLQ-LC13 dyspnea symptom subscale."}
  • {"endpoint_text":"- OR, defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the date of randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.","definition_or_measurement_approach":"Best overall response (CR or PR) per RECIST 1.1 by investigator assessment from randomisation until earliest of progression, death, last evaluable tumour assessment before subsequent therapy, loss to follow-up, or withdrawal."}
  • {"endpoint_text":"- Occurrence of treatment-emergent CRS during the on-treatment period.","definition_or_measurement_approach":"Descriptive assessment of the proportion of participants with treatment-emergent cytokine release syndrome (CRS) during the on-treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent ICANS during the on-treatment period.","definition_or_measurement_approach":"Descriptive assessment of the proportion of participants with treatment-emergent immune effector cell-associated neurotoxicity syndrome (ICANS) during the on-treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent AEs leading to trial medication discontinuation during the on-treatment period.","definition_or_measurement_approach":"Descriptive assessment of the proportion of participants with treatment-emergent adverse events that lead to discontinuation of trial medication during the on-treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent AEs leading to trial medication dose delay during the on-treatment period.","definition_or_measurement_approach":"Descriptive assessment of proportion of participants with treatment-emergent AEs causing dose delays during the on-treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent AEs leading to trial medication dose reduction during the on-treatment period.","definition_or_measurement_approach":"Descriptive assessment of proportion of participants with treatment-emergent AEs causing dose reductions during the on-treatment period."}
  • {"endpoint_text":"- Time to deterioration (TTD), defined as time from randomisation to deterioration maintained for 2 consecutive assessments or 1 assessment followed by death from any cause within 3 weeks for symptom scales: o Dyspnea as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13 o Chest pain as measured by EORTC-QLQ-LC13 o Cough as measured by EORTC-QLQ-LC13","definition_or_measurement_approach":"TTD defined as time from randomisation to deterioration maintained for 2 consecutive assessments or 1 assessment followed by death within 3 weeks for symptom scales (dyspnea by EORTC-QLQ-C30 and QLQ-LC13; chest pain and cough by QLQ-LC13)."}
  • {"endpoint_text":"- Change from baseline to Week 19 in symptom scales of the and EORTC QLQ-LC13 o Chest pain as measured by EORTC-QLQ-LC13 o Cough as measured by EORTC-QLQ-LC13","definition_or_measurement_approach":"Change from baseline to Week 19 in EORTC QLQ-LC13 symptom scales for chest pain and cough."}

Recruitment

Planned Sample Size
379
Recruitment Window Months
36
Consent Approach
Informed consent is obtained from participants. Country-specific subject information and informed consent forms are provided (multiple country/language ICFs were submitted: e.g. English, German, French, Spanish, Italian, Polish, Hungarian, Latvian, Portuguese and others). Documents for partner/pregnancy information are provided in several countries. No specific assent process for minors or other vulnerable groups is described in the available documentation.

Geography

Total Number Of Sites
56
Total Number Of Participants
138

Belgium

Earliest CTIS Part Ii Submission Date
23-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
19
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Chirec
Department Name
CHIREC Cancer Institute (CCI)
Principal Investigator Name
Christophe Compère
Principal Investigator Email
christophe.compere@chirec.be
Contact Person Name
Christophe Compère
Contact Person Email
christophe.compere@chirec.be
Site Name
UZ Leuven
Department Name
Respiratory Oncology Unit
Principal Investigator Name
Els Wauters
Principal Investigator Email
els.wauters@uzleuven.be
Contact Person Name
Els Wauters
Contact Person Email
els.wauters@uzleuven.be
Site Name
UZ Brussel
Department Name
Medische Oncologie
Principal Investigator Name
Lore Decoster
Principal Investigator Email
lore.decoster@uzbrussel.be
Contact Person Name
Lore Decoster
Contact Person Email
lore.decoster@uzbrussel.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Hospitalization ward for oncology – route 13
Principal Investigator Name
Jo Raskin
Principal Investigator Email
jo.raskin@uza.be
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be

Czechia

Earliest CTIS Part Ii Submission Date
28-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
15
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
University Hospital Olomouc
Department Name
Department of Pulmonary diseases and tuberculosis
Principal Investigator Name
Juraj Kultan
Principal Investigator Email
juraj.kultan@fnol.cz
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Pneumologická klinika 1. LFUK
Principal Investigator Name
Marie Drosslerova
Principal Investigator Email
marie.drosslerova@ftn.cz
Contact Person Name
Marie Drosslerova
Contact Person Email
marie.drosslerova@ftn.cz

Finland

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
19
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Turku University Hospital
Department Name
T-hospital, oncology department
Principal Investigator Name
Maria Silvoniemi
Principal Investigator Email
maria.silvoniemi@varha.fi
Contact Person Name
Maria Silvoniemi
Contact Person Email
maria.silvoniemi@varha.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Syöpätautien poliklinikka
Principal Investigator Name
Okko Kääriäinen
Principal Investigator Email
okko.kaariainen@pshyvinvointialue.fi
Contact Person Name
Okko Kääriäinen
Site Name
Oulu University Hospital
Department Name
Syöpä- ja veritautien pkl 2, N6 3.krs,
Principal Investigator Name
Jussi Koivunen
Principal Investigator Email
jussi.koivunen@pohde.fi
Contact Person Name
Jussi Koivunen
Contact Person Email
jussi.koivunen@pohde.fi

Germany

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
12
Number Of Sites
14
Number Of Participants
39

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Pius Jung
Principal Investigator Email
jung_p1@ukw.de
Contact Person Name
Pius Jung
Contact Person Email
jung_p1@ukw.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Innere Medizin – Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Jan Eucker
Principal Investigator Email
jan.eucker@vivantes.de
Contact Person Name
Jan Eucker
Contact Person Email
jan.eucker@vivantes.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Not applicable
Principal Investigator Name
Nikolaj Frost
Principal Investigator Email
nikolaj.frost@charite.de
Contact Person Name
Nikolaj Frost
Contact Person Email
nikolaj.frost@charite.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Tumorbiologie und Innere Medizin I
Principal Investigator Name
Justyna Rawluk
Principal Investigator Email
justyna.rawluk@uniklinik-freiburg.de
Contact Person Name
Justyna Rawluk
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik und Poliklinik, Allgemeine Innere Medizin
Principal Investigator Name
Georg Evers
Principal Investigator Email
georg.evers@ukmuenster.de
Contact Person Name
Georg Evers
Contact Person Email
georg.evers@ukmuenster.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Principal Investigator Name
Martin Kirschner
Principal Investigator Email
mkirschner@ukaachen.de
Contact Person Name
Martin Kirschner
Contact Person Email
mkirschner@ukaachen.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Zentrum für Pneumologie und Thoraxchirurgie, Onkologischer Schwerpunkt
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
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxonkologie Heidelberg
Principal Investigator Name
Farastuk Bozorgmehr
Principal Investigator Email
farastuk.bozorgmehr@med.uni-heidelberg.de
Contact Person Name
Farastuk Bozorgmehr
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Hämatologie und Medizinische Onkologie der Universitätsmedizin Göttingen
Principal Investigator Name
Tobias Overbeck
Principal Investigator Email
tobias.overbeck@med.uni-goettingen.de
Contact Person Name
Tobias Overbeck
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Thorakale Onkologie
Principal Investigator Name
Niels Reinmuth
Principal Investigator Email
n.reinmuth@asklepios.com
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Klinikum Harburg
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
Goethe University Frankfurt
Department Name
Medizinische Klinik 2 - Hämatologie / Onkologie
Principal Investigator Name
Maximilian Rost
Principal Investigator Email
rost@med.uni-frankfurt.de
Contact Person Name
Maximilian Rost
Contact Person Email
rost@med.uni-frankfurt.de
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik für Hämatologie und Onkologie, Universitätsklinik für Innere Medizin Onkologie
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I, Head Early Clinical Trial Unit
Principal Investigator Name
Martin Wermke
Principal Investigator Email
martin.wermke@uniklinikum-dresden.de
Contact Person Name
Martin Wermke

Greece

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
85
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Clinic and Clinical Trials Department
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd University Pathology Clinic
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonology Department
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr

Hungary

Earliest CTIS Part Ii Submission Date
22-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
23
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
Pulmonology Department
Principal Investigator Name
Gabriella Temesi
Principal Investigator Email
temesi@koranyi.hu
Contact Person Name
Gabriella Temesi
Contact Person Email
temesi@koranyi.hu
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Not applicable
Principal Investigator Name
Gabriella Gálffy
Principal Investigator Email
ggalffy@hotmail.com
Contact Person Name
Gabriella Gálffy
Contact Person Email
ggalffy@hotmail.com
Site Name
University Of Debrecen
Department Name
Department of Pulmonology
Principal Investigator Name
Tamás Kardos
Principal Investigator Email
kardostom@yahoo.co.uk
Contact Person Name
Tamás Kardos
Contact Person Email
kardostom@yahoo.co.uk
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Not applicable
Principal Investigator Name
Yousuf Al-Farhat
Principal Investigator Email
yalfarhat@gmail.com
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yalfarhat@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Oncoradiology Center
Principal Investigator Name
Zsuzsanna Kelemen
Principal Investigator Email
study.zsuzsannadrkelemen@gmail.com
Contact Person Name
Zsuzsanna Kelemen

Ireland

Earliest CTIS Part Ii Submission Date
06-05-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
9
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Cork University Hospital
Department Name
Glandore Centre
Principal Investigator Name
Sinéad Noonan
Principal Investigator Email
Sinead.noonan@hse.ie
Contact Person Name
Sinéad Noonan
Contact Person Email
Sinead.noonan@hse.ie

Italy

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
85
Number Of Sites
10
Number Of Participants
25

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Struttura Semplice Dipartimentale di Oncologia Toracica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
DAI di Chirurgia e Oncologia - U.O.C. Oncologia Medica
Principal Investigator Name
Lorenzo Belluomini
Principal Investigator Email
lorenzo.belluomini@univr.it
Contact Person Name
Lorenzo Belluomini
Contact Person Email
lorenzo.belluomini@univr.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncologia Medica
Principal Investigator Name
Salvatore Grisanti
Principal Investigator Email
grisanti.salvatore@gmail.com
Contact Person Name
Salvatore Grisanti
Contact Person Email
grisanti.salvatore@gmail.com
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Oncologia
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@unifi.it
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@unifi.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
SC Oncologia Medica
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Dip. Oncologia Medica
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
UOS DH ONCOLOGICO
Principal Investigator Name
Marco Russano
Principal Investigator Email
m.russano@policlinicocampus.it
Contact Person Name
Marco Russano
Contact Person Email
m.russano@policlinicocampus.it
Site Name
Istituto Oncologico Veneto
Department Name
U.O. Oncologia 2
Principal Investigator Name
Giulia Pasello
Principal Investigator Email
giulia.pasello@iov.veneto.it
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.S.D. Oncologia Polmonare
Principal Investigator Name
Francesco Passiglia
Principal Investigator Email
francesco.passiglia@unito.it
Contact Person Name
Francesco Passiglia
Contact Person Email
francesco.passiglia@unito.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica Patologia Toracica
Principal Investigator Name
Vito Longo
Principal Investigator Email
v.longo@oncologico.bari.it
Contact Person Name
Vito Longo
Contact Person Email
v.longo@oncologico.bari.it

Latvia

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
85
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Rigas Austrumu kliniska universitates slimnica SIA
Department Name
University Hospital and Oncology Centre
Principal Investigator Name
Zanete Zvirbule
Principal Investigator Email
zanete.zvirbule@aslimnica.lv
Contact Person Name
Zanete Zvirbule
Contact Person Email
zanete.zvirbule@aslimnica.lv
Site Name
Pauls Stradins Clinical University Hospital
Department Name
Oncology Clinic
Principal Investigator Name
Viktors Kozirovskis
Principal Investigator Email
viktors.kozirovskis@stradini.lv
Contact Person Name
Viktors Kozirovskis

Portugal

Earliest CTIS Part Ii Submission Date
22-04-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
22
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Hospital CUF Porto S.A.
Department Name
Pneumology Service
Principal Investigator Name
Jose Lopes
Principal Investigator Email
jose.albino.lopes@cuf.pt
Contact Person Name
Jose Lopes
Contact Person Email
jose.albino.lopes@cuf.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Department Oncologia Médica
Principal Investigator Name
Maurício Peixoto’s
Principal Investigator Email
mauricio.peixoto@uslb.min-saude.pt
Contact Person Name
Maurício Peixoto’s
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Centro de Investigação
Principal Investigator Name
Rita Félix
Principal Investigator Email
i13033@ipoporto.min-saude.pt
Contact Person Name
Rita Félix
Contact Person Email
i13033@ipoporto.min-saude.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Hospital de Dia, Edifício S Jerónimo
Principal Investigator Name
Ana Figueiredo
Principal Investigator Email
amrfigueiredo@gmail.com
Contact Person Name
Ana Figueiredo
Contact Person Email
amrfigueiredo@gmail.com
Site Name
Hospital Da Luz S.A.
Department Name
Piso-1
Principal Investigator Name
João Godinho
Principal Investigator Email
joao.batista.godinho@hospitaldaluz.pt
Contact Person Name
João Godinho

Sweden

Earliest CTIS Part Ii Submission Date
01-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
42
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Karolinska University Hospital
Department Name
Studie behandlingsavdelning, B08:09
Principal Investigator Name
Luigi De Petris
Principal Investigator Email
luigi.depetris@regionstockholm.se
Contact Person Name
Luigi De Petris
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Oncology department
Principal Investigator Name
Andreas Hallqvist
Principal Investigator Email
andreas.hallqvist@vgregion.se
Contact Person Name
Andreas Hallqvist
Contact Person Email
andreas.hallqvist@vgregion.se
Site Name
Region Gaevleborg
Department Name
Lungenheten
Principal Investigator Name
Johan Isaksson
Principal Investigator Email
johan.isaksson@regiongavleborg.se
Contact Person Name
Johan Isaksson

Poland

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
15
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
Kliniczny Oddzial Onkologii Klinicznej
Principal Investigator Name
Teresa Zarzycka
Principal Investigator Email
zarzyckat@gmail.com
Contact Person Name
Teresa Zarzycka
Contact Person Email
zarzyckat@gmail.com
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oncology Department with Chemotherapy Sub-Division
Principal Investigator Name
Jarosław Kołb-Sielecki
Principal Investigator Email
j.kolbsielecki@gmail.com
Contact Person Name
Jarosław Kołb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Department of Oncology
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
ewakalinka@wp.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology and Radiotherapy Clinic
Principal Investigator Name
Rafal Dziadziuszko
Principal Investigator Email
rafald@gumed.edu.pl
Contact Person Name
Rafal Dziadziuszko
Contact Person Email
rafald@gumed.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Department and Clinic of Pulmonology, Oncology, and Allergology
Principal Investigator Name
Tomasz Jankowski
Principal Investigator Email
tjankowski.onkolog@wp.pl
Contact Person Name
Tomasz Jankowski
Contact Person Email
tjankowski.onkolog@wp.pl

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
sponsorDuties codes: 1, 12, 15 (15 indicated as 'Study start-up'); contact euctr_greece@iqvia.com
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 1, 12, 15 (15 indicated as 'Study start-up'); contact josephine.kench@iqvia.com

Third parties

  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1, 12, 15 (value for code 15: \"Study start-up\"); contact euctr_greece@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 15 (value for code 15: \"Study start-up\"); contact josephine.kench@iqvia.com","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)
Dose Levels
Carboplatin AUC 5 (product listing); max daily amount recorded 750 mg
Maximum Dose
750 mg (max daily amount listed)
Investigational Product Name
RoActemra 20 mg/mL concentrate for solution for infusion
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Dose Levels
Product lists max daily amount 2400 mg; max total 3200 mg
Maximum Dose
2400 mg (max daily amount listed)
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Dose Levels
1200 mg fixed dose (product lists max daily amount 1200 mg)
Maximum Dose
1200 mg (daily/fixed dose listed)
Investigational Product Name
BI 764532
Active Substance
IGG-LIKE T CELL ENGAGER BINDING TO DLL3 AND CD3
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Not authorised (investigational product)
Orphan Designation
Yes
Investigational Product Name
Etoposid Hikma 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Dose Levels
Etoposide 80-100 mg/m2 (per inclusion criteria); product lists max daily 100 mg/m2
Maximum Dose
100 mg/m2 (max daily amount listed)
Combination Treatment
Yes

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