Clinical trial • Phase III • Oncology

durvalumab for Small-cell lung cancer (limited stage)

Phase III trial of durvalumab 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

Key dates

Initial CTIS Submission Date
03-06-2024
First CTIS Authorization Date
27-06-2024

Trial design

Randomised, placebo (iv) q4w in combination with a second placebo (iv) q4w for 4 doses/cycles each, followed by placebo monotherapy (iv) q4w from cycle 5; active comparator arms described: durvalumab (1500 mg iv) q4w (monotherapy arm) and durvalumab (1500 mg iv q4w) + tremelimumab (75 mg iv q4w for 4 doses) (combination arm).-controlled Phase III trial in Germany, Poland, Czechia and others.

Randomised
Yes
Comparator
Placebo (IV) q4w in combination with a second placebo (IV) q4w for 4 doses/cycles each, followed by placebo monotherapy (IV) q4w from Cycle 5; active comparator arms described: Durvalumab (1500 mg IV) q4w (monotherapy arm) and Durvalumab (1500 mg IV q4w) + Tremelimumab (75 mg IV q4w for 4 doses) (combination arm).
Target Sample Size
562
Trial Duration For Participant
730

Eligibility

Recruits 562 Vulnerable populations selected. Subject information sheets and informed consent forms for adults and for pregnant partners are listed in the trial documents (multiple language versions), indicating consent processes are defined for adult participants and pregnant partners; no paediatric consent/assent documentation is listed in the available records..

Vulnerable Population
Vulnerable populations selected. Subject information sheets and informed consent forms for adults and for pregnant partners are listed in the trial documents (multiple language versions), indicating consent processes are defined for adult participants and pregnant partners; no paediatric consent/assent documentation is listed in the available records.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC any, N any, i.e., patients whose disease can be encompassed within a radical radiation portal - Patients with Stage I to IIA disease must be medically inoperable as determined by investigator."}
  • {"criterion_text":"- Received an appropriate first line concurrent chemoradiotherapy regimen as defined below, unless after consultation with the global study medical team an alternative is acceptable, received 4 cycles of platinum-based chemotherapy concurrent with RT, which must be completed within 1 to 42 days prior to first dose of IP."}
  • {"criterion_text":"- The chemotherapy regimen must contain platinum and IV etoposide administered, as per local standard-of-care regimens."}
  • {"criterion_text":"- The radiotherapy must have commenced no later than the end of Cycle 2 of chemotherapy and patients must have received a total dose of radiation of 60 to 66 Gy over 6 weeks for standard QD radiation schedules or 45 Gy over 3 weeks for hyperfractionated BID radiation schedules."}
  • {"criterion_text":"- Patients must have achieved CR, PR, or SD and not have progressed following definitive, platinum-based chemotherapy, concurrent with RT."}
  • {"criterion_text":"- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment and randomization."}
  • {"criterion_text":"- Mandatory availability of tumor sample, which may include a core needle biopsy, newly cut unstained slides, or fine needle aspirate (FNA) cell block samples. Tissue sample should be submitted before or within 60 days of randomization. However, patients may be enrolled into the study before the pre-treatment tumor tissue sample is submitted."}
  • {"criterion_text":"- A newly acquired tumor biopsy (taken following completion of chemoradiotherapy) is optional, provided that a biopsy procedure is technically feasible, and the procedure is not associated with unacceptable clinical risk."}
  • {"criterion_text":"- PCI may be delivered at the discretion of investigator and per local standard of care, and completion within 42 days of completion of concurrent CRT."}

Exclusion criteria

  • {"criterion_text":"- Extensive-stage SCLC."}
  • {"criterion_text":"- Mixed SCLC and NSCLC histology."}
  • {"criterion_text":"- Brain metastases or spinal cord compression."}
  • {"criterion_text":"- All patients will have an MRI (preferred) or CT, preferably with IV contrast of the brain, after completion of first line concurrent chemoradiotherapy and within 1 to 42 days prior to randomization and the first dose of IP."}
  • {"criterion_text":"- Patients who received sequential chemoradiation therapy for LS-SCLC (no overlap of RT with chemotherapy)."}
  • {"criterion_text":"- Receipt of chemotherapy that exceeds 4 cycles in total."}
  • {"criterion_text":"- Chemotherapy regimens other than etoposide and platinum are not permitted."}
  • {"criterion_text":"- Any history of Grade ≥2 pneumonitis"}
  • {"criterion_text":"- Active or prior documented autoimmune/inflammatory disorders, uncontrolled intercurrent illness or active infections"}
  • {"criterion_text":"- Prior exposure to immune-mediated therapy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS using BICR assessments according to RECIST 1.1","definition_or_measurement_approach":"PFS assessed using Blinded Independent Central Review (BICR) according to RECIST 1.1"}
  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause"}

Secondary endpoints

  • {"endpoint_text":"- PFS, ORR, PFS18, PFS24, and TTDM using BICR assessments according to RECIST 1.1","definition_or_measurement_approach":"Assessments (PFS, ORR, timepoint-specific PFS measures and time to death or metastasis) using BICR per RECIST 1.1"}
  • {"endpoint_text":"- OS, OS24, OS36","definition_or_measurement_approach":"Overall survival and timepoint-specific OS (24 and 36 months)"}
  • {"endpoint_text":"- PFS2","definition_or_measurement_approach":"Second progression-free survival (PFS2) as specified in protocol"}
  • {"endpoint_text":"- EORTC QLQ-C30 and QLQ-LC13: change in symptoms, functioning, and global health status/QoL","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC QLQ-C30 v3 and QLQ-LC13 assessing symptoms, functioning and global health status/quality of life"}
  • {"endpoint_text":"- Concentration of durvalumab and tremelimumab in serum (such as peak concentration and trough; sparse sampling)","definition_or_measurement_approach":"Pharmacokinetic measurements (serum concentration, peak and trough) by sparse sampling"}
  • {"endpoint_text":"- Presence of ADA for durvalumab and tremelimumab","definition_or_measurement_approach":"Assessment of anti-drug antibodies (immunogenicity) for durvalumab and tremelimumab"}
  • {"endpoint_text":"- PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS, and ORR).","definition_or_measurement_approach":"Biomarker analysis of PD-L1 expression in tumor/immune cells correlated with efficacy outcomes (PFS, OS, ORR)"}
  • {"endpoint_text":"- Safety assessment: AEs; laboratory findings including clinical chemistry, hematology, urinalysis; physical examinations; vital signs including blood pressure and pulse; and electrocardiograms","definition_or_measurement_approach":"Safety evaluated by adverse events, laboratory tests (clinical chemistry, hematology, urinalysis), physical exams, vital signs and ECGs"}

Recruitment

Planned Sample Size
562
Recruitment Window Months
21
Consent Approach
Informed consent obtained from adult participants. Subject information sheets and informed consent forms are provided for adults and for pregnant partners; multiple language versions are available (English, Dutch, Polish, Spanish, Italian, French, Czech, German as evidenced by the document listings). No paediatric assent documents are listed in the available records.

Geography

Total Number Of Sites
47
Total Number Of Participants
168

Germany

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
28-02-2025
Processing Time Days
257
Number Of Sites
11
Number Of Participants
41

Sites

Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Department Name
Gemeinschaftspraxis für Hämatologie und Onkologie
Contact Person Name
Christian Lerchenmüller
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin II Bereich Pneumologie
Contact Person Name
Christian Schulz
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Innere Medizin - Onkologie
Contact Person Name
Michael Thomas
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Lungenklinik Köln-Merheim
Contact Person Name
Eva Lotte Buchmeier
Contact Person Email
buchmeierE@kliniken-koeln.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik Universitäres Centrum für Tumorerkrankungen Gebäude 302 Studienzentrale
Contact Person Name
Jürgen Alt
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Studienzentrum Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Frank Griesinger
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Comprehensive Cancer Center Mainfranken Interdisziplinäres Studienzentrum, Haus C16
Contact Person Name
Jens Kern
Contact Person Email
jens.kern@kwm-klinikum.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Innere Medizin  Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
Robert Bosch Krankenhaus GmbH
Department Name
Klinik Schillerhöhe Abteilung für Pneumologische Onkologie
Contact Person Name
Hans-Georg Kopp
Contact Person Email
hans-georg.kopp@rbk.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin I Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
Contact Person Name
Justyna Rawluk

Poland

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
02-03-2025
Processing Time Days
259
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Department Name
Oddzial Chemioterapii
Contact Person Name
Ewa Chmielowska
Contact Person Email
ewa.chmielowska@nu-med.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Andrzej Badzio
Contact Person Email
abadzio@gumed.edu.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddzial Onkologii Klinicznej / Chemioterapii Leczenie Skojarzone – Chemioterapia Dzienna
Contact Person Name
Marcin Golecki
Contact Person Email
golecki.marcin@dco.com.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzial Onkologii z Pododdzialem chemioterapii
Contact Person Name
Jaroslaw Kolb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Pluc i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@nio.gov.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzial Onkologii z Pododdzialem chemioterapii

Czechia

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
27-02-2025
Processing Time Days
256
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Pneumologická klinika 1.LF UK A FTN
Contact Person Name
Markéta Černovská
Contact Person Email
marketa.cernovska@ftn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika nemocí plicních a tuberkulózy
Contact Person Name
Bohdan Kadlec
Contact Person Email
kadlec.bohdan@fnbrno.cz
Site Name
Fakultni Nemocnice Brno (AGEL Ostrava-Vitkovice)
Department Name
Plicní oddělení
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz
Site Name
University Hospital Olomouc
Department Name
Klinika nemocí plicních a tuberkulózy
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologická klinika
Contact Person Name
Milada Zemánová
Contact Person Email
Milada.Zemanova@vfn.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Plicní klinika
Contact Person Name
Michal Hrnčiarik
Contact Person Email
michal.hrarik@fnhk.cz

Belgium

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
28-02-2025
Processing Time Days
257
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Jessa Ziekenhuis
Department Name
Respiratory Oncology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Onze-Lieve-Vrouwziekenhuis
Department Name
Pneumology
Contact Person Name
Piet Vercauter
Contact Person Email
piet.vercauter@olvz-aalst.be
Site Name
Institut Jules Bordet
Department Name
Clinique d'Oncologie Médicale
Contact Person Name
Bogdan Grigoriu
Contact Person Email
bogdan.grigoriu@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Contact Person Name
Frank Aboubakar Nana
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pneumology
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be

Spain

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
26-02-2025
Processing Time Days
255
Number Of Sites
11
Number Of Participants
68

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology Service
Contact Person Name
Maria Eugenia Olmedo Garcia
Contact Person Email
maruolmedogarcia@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Service
Contact Person Name
Reyes Bernabé Caro
Contact Person Email
reyesbernab@yahoo.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology Service
Contact Person Name
Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology Service
Contact Person Name
Manuel Dominé Gómez
Site Name
Hospital Del Mar
Department Name
Oncology Service
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@hospitaldelmar.cat
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology Service
Contact Person Name
Noemí Villanueva Palicio
Contact Person Email
noemivipa@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology Service
Contact Person Name
Pedro Filipe Simoes Da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology Service
Contact Person Name
Luis Paz-Ares Rodirguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology Service
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario Ramon Y Cajal (additional site listing)
Department Name
Oncology Service
Site Name
Hospital Universitario Fundacion Jimenez Diaz (additional site listing)
Department Name
Oncology Service

Netherlands

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
03-03-2025
Processing Time Days
260
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Longziekten en Tuberculose
Contact Person Name
Birgitta Hiddinga
Contact Person Email
b.i.hiddinga@umcg.nl
Site Name
Amsterdam UMC
Department Name
Afdeling Longziekten
Contact Person Name
Sayed Hashemi
Contact Person Email
s.hashemi@amsterdamumc.nl
Site Name
Jeroen Bosch Ziekenhuis
Department Name
Longoncologie
Contact Person Name
Bonne Biesma
Contact Person Email
B.Biesma@jbz.nl
Site Name
Ziekenhuis St Jansdal
Department Name
Longziekten
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl

Italy

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
31-07-2025
Processing Time Days
410
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Radioterapia Oncologica (UOC)
Contact Person Name
Maria Antonietta Gambacorta
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia medica toraco-polmonare
Contact Person Name
Claudia Proto
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SSD Oncologia Polmonare
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Oncologia Medica
Contact Person Name
Cristina Zannori
Contact Person Email
c.zannori@aospterni.it

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
durvalumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (EU MA: EU/1/18/1322/002)
Starting Dose
1500 mg
Dose Levels
1500 mg
Frequency
every 4 weeks (q4w)
Maximum Dose
1500 mg
Investigational Product Name
IMJUDO 20 mg/ml concentrate for solution for infusion.
Active Substance
tremelimumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (EU MA: EU/1/22/1713/002)
Starting Dose
75 mg
Dose Levels
75 mg
Frequency
every 4 weeks (q4w) for 4 doses (when given in combination)
Maximum Dose
75 mg
Combination Treatment
Yes

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