Clinical trial • Phase III • Oncology

CERALASERTIB for Advanced or metastatic non-small cell lung cancer | Non-small cell lung cancer

Phase III trial of CERALASERTIB for Advanced or metastatic non-small cell lung cancer | Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced or metastatic non-small cell lung cancer | Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-12-2023
First CTIS Authorization Date
31-01-2024

Trial design

Randomised, open-label, ceralasertib plus durvalumab (investigational combination) versus docetaxel (comparator). docetaxel dosing information in ctis: 75 mg/m2 (doseuom mg/m2; maxdailydoseamount 75) administered iv; specific schedule not further specified in the ctis record. ceralasertib (oral) and durvalumab (intravenous, imfinzi) dosing schedules not fully specified in the ctis record.-controlled Phase III trial across 77 sites in Belgium, Germany, Ireland and others.

Randomised
Yes
Open Label
Yes
Comparator
Ceralasertib plus Durvalumab (investigational combination) versus Docetaxel (comparator). Docetaxel dosing information in CTIS: 75 mg/m2 (doseUom mg/m2; maxDailyDoseAmount 75) administered IV; specific schedule not further specified in the CTIS record. Ceralasertib (oral) and Durvalumab (intravenous, IMFINZI) dosing schedules not fully specified in the CTIS record.
Target Sample Size
372

Eligibility

Recruits 372 Vulnerable population selected (isVulnerablePopulationSelected = true). Study enrolls adults only (participants must be ≥ 18 years). Informed consent is required from each participant; multiple country-specific ICF documents are provided (see documents list). No assent procedures for minors are applicable because minors are excluded..

Pregnancy Exclusion
Negative pregnancy test (serum test) for WOCBP.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Study enrolls adults only (participants must be ≥ 18 years). Informed consent is required from each participant; multiple country-specific ICF documents are provided (see documents list). No assent procedures for minors are applicable because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Participant must be ≥ 18 years at the time of screening.\n- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.\n- Documented EGFR and ALK wild-type status as determined at a local laboratory.\n- Documented radiological PD whilst on or after receiving the most recent treatment regimen.\n- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.\n- ECOG/WHO performance status of 0 or 1.\n- Adequate organ function and marrow reserve\n- Minimum life expectancy of 12 weeks.\n- Body weight > 30 kg and no cancer-associated cachexia.\n- Negative pregnancy test (serum test) for WOCBP."}

Exclusion criteria

  • {"criterion_text":"- Participant with mixed SCLC and NSCLC histology\n- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.\n- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.\n- Active or prior documented autoimmune or inflammatory disorders.\n- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.\n- Participants: (a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy. (b) All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved. (c) Must not have experienced a Grade ≥ 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy. (d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.\n- Participants who have received more than one prior line of platinum- based chemotherapy in metastatic setting.\n- Participants who have received a prior ATR inhibitor."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- OS is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.","definition_or_measurement_approach":"OS defined as time from randomisation to date of death from any cause; comparison includes all randomised participants; measure of interest is hazard ratio (HR) of OS."}

Secondary endpoints

  • {"endpoint_text":"- To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, DoR, TTR, DCR at 18 weeks, PFS2, OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability.","definition_or_measurement_approach":"Composite of multiple efficacy and patient-reported endpoints: progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), time to response (TTR), disease control rate (DCR) at 18 weeks, PFS2, overall survival at 12 months (OS12), and participant-reported QoL, physical functioning, and treatment tolerability (assessment methods not detailed in CTIS record)."}
  • {"endpoint_text":"- To assess the PK of ceralasertib when administered in combination with durvalumab.","definition_or_measurement_approach":"Pharmacokinetic assessment of ceralasertib when given with durvalumab (PK sampling and analysis; specific PK parameters not detailed in CTIS record)."}
  • {"endpoint_text":"- To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel","definition_or_measurement_approach":"Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), and other safety measures (CTCAE grading); specific schedules not provided in CTIS record."}

Recruitment

Planned Sample Size
372
Recruitment Window Months
53
Consent Approach
Informed consent is required from each adult participant (participants must be ≥ 18). Multiple country- and language-specific informed consent documents are provided (ICF documents listed for English, French, Dutch, Polish, Hungarian, Spanish, Italian, German, Romanian, Ukrainian and others). No assent procedures for minors are described (minors are excluded).

Geography

Total Number Of Sites
77
Total Number Of Participants
520

Belgium

Latest Decision Or Authorization Date
05-02-2024
Number Of Sites
4
Number Of Participants
33

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
0501:Department of Pulmonary Diseas
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
Grand Hopital De Charleroi
Department Name
0504: Oncologie - Hématologie
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Hopital De Libramont
Department Name
0502:Oncologie
Contact Person Name
Frédéric Forget
Contact Person Email
frederic.forget@vivalia.be
Site Name
Universitair Ziekenhuis Gent
Department Name
0503:Pneumologie
Contact Person Name
Veerle Surmont
Contact Person Email
veerle.surmont@uzgent.be

Germany

Latest Decision Or Authorization Date
02-02-2024
Number Of Sites
9
Number Of Participants
22

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
2606 : Klinik fuer Innere Medizin II
Contact Person Name
Cornelia Kropf-Sanchen
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
2605 : Standort Fachklinik Löwenstein, Med.Klinik II Onkologie mit Palliativmedizin
Contact Person Name
Jonas Kuon
Contact Person Email
jonas.kuon@slk-kliniken.de
Site Name
Medical Center - University Of Freiburg
Department Name
2608 : Klinik für Innere Medizin I
Contact Person Name
Cornelius Waller
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
2604 : Lungenkrebszentrum Moers
Contact Person Name
Karl-Otto Kambartel
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
2607 : Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin Klinikum Kempten
Contact Person Name
Christian Schumann
Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
2602 : Medizinische Klinik Abteilung2, Hämatologie, Onkologie, Immunologie und Palliativmedizin
Contact Person Name
Christian Meyer zum Bueschenfelde
Contact Person Email
christian.mzb@vincentius-ka.de
Site Name
Asklepios Fachkliniken Muenchen Gauting
Department Name
2601 : Zentrum für Pneumologie und Thoraxchirurgie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
2609 : Klinik für Innere Medizin
Contact Person Name
Florian Weissinger
Contact Person Email
Florian.Weissinger@evkb.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
2603 : Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de

Ireland

Latest Decision Or Authorization Date
31-01-2024
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
St Vincent's University Hospital
Department Name
3902:2nd Floor
Contact Person Name
Emer Hanrahan
Contact Person Email
e.hanrahan@svuh.ie
Site Name
Beaumont Hospital
Department Name
3903:Oncology
Contact Person Name
Jarushka Naidoo
Contact Person Email
jarushkanaidoo@beaumont.ie
Site Name
University College Cork
Department Name
3901:Cancer Trials Cork, Glandore Centre
Contact Person Name
Dearbhaile Collins
Contact Person Email
Dearbhaile.Collins@hse.ie
Site Name
University Hospital Limerick
Department Name
3904:Mid-Western Cancer Centre
Contact Person Name
Grzegorz Korpanty
Contact Person Email
greg.korpanty2@hse.ie

Poland

Latest Decision Or Authorization Date
02-02-2024
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Pratia S.A.
Department Name
5707 : Centrum Medyczne Pratia Poznan
Contact Person Name
Marcin Grabicki
Contact Person Email
grabicki@10g.pl
Site Name
Med Polonia Sp. z o.o.
Department Name
5703 : MED-POLONIA Sp.z o.o.
Contact Person Name
Rodryg Ramlau
Contact Person Email
rramlau@gmail.com
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
5705 : Oddzial Onkologii Klinicznej / Chemioterapii
Contact Person Name
Joanna Wojcik - Tomaszewska
Contact Person Email
jwojcik@wco.gda.pl
Site Name
Pratia S.A. (Cracow)
Department Name
5702 : Pratia MCM Krakow
Contact Person Name
Anna Drosik-Kwasniewska
Contact Person Email
adkwasniewska@gmail.com
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
5701 : Oddzial Onkologii Klinicznej z Pododdzialem Dziennym
Contact Person Name
Anna Kowalczyk - Tekiela
Contact Person Email
atekiela@interia.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
5706 : Klinika Onkologii i Radioterapii
Contact Person Name
Jacek Jassem
Contact Person Email
jjassem@gumed.edu.pl
Site Name
Additional Polish site

Italy

Latest Decision Or Authorization Date
08-02-2024
Number Of Sites
11
Number Of Participants
83

Sites

Site Name
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
4113: UOC Oncologia Medica
Contact Person Name
Alessio Cortellini
Site Name
Istituto Oncologico Veneto
Department Name
4104: Department of Clinical and Experimental Oncology
Contact Person Name
Laura Bonanno
Contact Person Email
laura.bonanno@iov.veneto.it
Site Name
Istituto Nazionale Dei Tumori
Department Name
4108: Oncologia Medica Toraco Polmon
Contact Person Name
Giuseppe Lo Russo
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
4101: Biostatistica
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Humanitas Research Hospital
Department Name
4107: Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi
Contact Person Email
luca.toschi@humanitas.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
4103: U.O.Oncologia Medica e dei Tumori Immuno-correlati
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
4110: UOC Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
4106: Oncologia Clinica Sperimentale Toraco-Polmonare
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
4102: Hemat/Transfusion Med
Contact Person Name
Marcello Tiseo
Contact Person Email
marcello.tiseo@unipr.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
4109: U.O. Oncologia Medica
Contact Person Name
Hector Jose Soto Parra
Contact Person Email
hsotoparra@yahoo.it
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
4105: Oncologia Toracica
Contact Person Name
Antonio Santo

Netherlands

Latest Decision Or Authorization Date
31-01-2024
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Gelre Hospitals
Department Name
5002:Poli Longziekten afd research
Contact Person Name
Ernst Lammers
Contact Person Email
lammers.research@gelre.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
5004:Pulmonology
Contact Person Name
Fred (Frank) Custers
Contact Person Email
f.custers@zuyderland.nl
Site Name
St. Elisabeth Hospital Tilburg
Department Name
5001:Pulmonology
Contact Person Name
Mart Schiefer
Contact Person Email
m.schiefer@etz.nl

Hungary

Latest Decision Or Authorization Date
01-02-2024
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Koranyi National Institute For Pulmonology
Department Name
3304:Pulmonológiai Osztály
Contact Person Name
Moldvay Judit
Contact Person Email
drmoldvay@hotmail.com
Site Name
Toeroekbalinti Tuedogyogyintezet
Department Name
3301:Onkológia Osztály
Contact Person Name
Gálffy Gabriella
Contact Person Email
ggalffy@hotmail.com
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
3302:Pulmonológiai Osztály
Contact Person Name
Pápai-Székely Zsolt
Contact Person Email
zsoltpapai@yahoo.com

France

Latest Decision Or Authorization Date
31-01-2024
Number Of Sites
14
Number Of Participants
95

Sites

Site Name
Centre Hospitalier De Saint-Quentin
Department Name
2307:Pneumologie
Contact Person Name
Charles Dayen
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
2309:Oncologie Médicale
Contact Person Name
Catherine Becht
Contact Person Email
becht@oncoclem.org
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
2304:Service de Pneumologie
Contact Person Name
Jean-Bernard Auliac
Site Name
Hopitaux Prives De Metz
Department Name
2305:Pneumologie
Contact Person Name
Benoît Godbert
Contact Person Email
benoit.godbert@uneos.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
2303:Service Oncologie Medicale
Contact Person Name
Sandrine Hiret
Site Name
Centre Leon Berard
Department Name
2311:Département d'Oncologie Médicale
Contact Person Name
Maurice Perol
Site Name
Centre Hospitalier Universitaire De Angers
Department Name
2306:Pneumologie
Contact Person Name
Youssef Oulkhouir
Site Name
Les Hopitaux Nord-Ouest
Department Name
2313:Oncologie Medicale - Cancerologie
Contact Person Name
Lionel Falchero
Contact Person Email
lfalchero@lhopitalnordouest.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
2312:Pneumologie - unité d'oncologie thoracique
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Centre Jean Perrin
Department Name
2314:Medecine
Contact Person Name
Pascale Dubray-Longeras
Contact Person Email
pascale.dubray-longeras@cjp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
2301:Maladies respiratoires
Contact Person Name
Remi Veillon
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
2315:Service d'Oncologie médicale
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elivre.pons@chu-nantes.fr
Site Name
Institut Gustave Roussy
Department Name
2302:Medecine Oncologique
Contact Person Name
Benjamin Besse
Site Name
HIA Sainte Anne
Department Name
2308:Service de pneumologie
Contact Person Name
Olivier Bylicki
Contact Person Email
bylicki.olivier@yahoo.fr

Romania

Latest Decision Or Authorization Date
26-02-2024
Number Of Sites
11
Number Of Participants
73

Sites

Site Name
Oncomed S.R.L.
Department Name
6105:Medical Oncology
Contact Person Name
Zoe Cristina CAPRARIU
Contact Person Email
zoeprejbeanu@yahoo.com
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
6107:Oncology
Contact Person Name
Laura Mazilu
Contact Person Email
lauragrigorov@gmail.com
Site Name
Oncolab S.R.L.
Department Name
6108:Medical oncology
Contact Person Name
Dan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Gral Medical S.R.L.
Department Name
6111:Oncology
Contact Person Name
Cristina TIUT
Contact Person Email
dr.cristinatiut@gmail.com
Site Name
Medisprof S.R.L.
Department Name
6109:Oncology
Contact Person Name
Anghel Adrian UDREA
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
6102:Oncologie Medicala I
Contact Person Name
Laurentia Nicoleta Gales
Contact Person Email
laurentia.gales@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
6101:Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Pelican Impex S.R.L.
Department Name
6110:Oncologie
Contact Person Name
Ioana CIURESCU
Contact Person Email
ioana_covaciu@yahoo.com
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
6104:Oncology
Contact Person Name
Roxana Scheusan
Contact Person Email
roxana.scheusan@oncocenter.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
6103:Oncology
Contact Person Name
Andrei UNGUREANU
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
6106:Oncologie Medicala
Contact Person Name
Alina Simona MUNTEAN
Contact Person Email
muntean.alina@yahoo.fr

Spain

Latest Decision Or Authorization Date
26-02-2024
Number Of Sites
11
Number Of Participants
142

Sites

Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
7119:Oncología
Contact Person Name
Margarita Amenedo Gancedo
Contact Person Email
margarita.amenedo@cog.es
Site Name
Hospital Clinico San Carlos
Department Name
7114:Oncología
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Universitario Regional De Malaga
Department Name
7103:Oncología
Contact Person Name
Manuel Cobo Dols
Site Name
Hospital Universitario Virgen De Valme
Department Name
7106:Oncología
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
7101:Oncología
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
7115:Oncología
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
7111:Oncología
Contact Person Name
Julia Giner
Contact Person Email
jginer@tauli.cat
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
7108:Oncología
Contact Person Name
Maria Areses Manrique
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
7117:Oncología
Contact Person Name
Manuel Dómine Gómez
Site Name
Institut Catala D'oncologia
Department Name
7113:Oncología
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Universitario Regional De Malaga (additional)

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Contract research organisation duties as listed (sponsorDuties codes: 1,10,11,12,13,2,5,6,8); contact Clinicaltrial.Enquiries@parexel.com

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,8 (as listed in CTIS record)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ceralasertib
Active Substance
CERALASERTIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
1
Investigational Product Name
Durvalumab (IMFINZI 50 mg/mL concentrate for solution for infusion.)
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
2
Maximum Dose
43500 mg (maxTotalDoseAmount as listed)
Investigational Product Name
Docetaxel
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
2
Starting Dose
75 mg/m2
Maximum Dose
2775 mg/m2 (maxTotalDoseAmount as listed)
Combination Treatment
Yes

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