Clinical trial • Phase III • Oncology
Atezolizumab for Extensive-stage small cell lung cancer
Phase III trial of Atezolizumab for Extensive-stage small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Extensive-stage small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 02-07-2024
Trial design
Randomised, open-label, atezolizumab monotherapy as maintenance (comparator arm) versus lurbinectedin in combination with atezolizumab (investigational arm). dose/schedule not specified in the ctis record for the arms; product entries list atezolizumab nominal dose value 1200 mg and lurbinectedin 3.2 mg/m2 but the protocol schedule is not provided in the json.-controlled Phase III trial across 47 sites in Belgium, Italy, Greece and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Atezolizumab monotherapy as maintenance (comparator arm) versus lurbinectedin in combination with atezolizumab (investigational arm). Dose/schedule not specified in the CTIS record for the arms; product entries list Atezolizumab nominal dose value 1200 mg and lurbinectedin 3.2 mg/m2 but the protocol schedule is not provided in the JSON.
- Target Sample Size
- 326
Eligibility
Recruits 326 paediatric patients.
- Vulnerable Population
- Vulnerable populations have been selected for the trial. The submission includes infant-specific consent/information document filenames (e.g. 'L1_SIS and ICF Infant', 'L1__Infant_AF', 'L1_Infant_IS') and documents for pregnant partners/patients (e.g. 'L1_Pregnant_Partner_AF', 'L1_Pregnant_Partner_IS'), indicating tailored materials for infants and pregnant partners are provided. The record does not provide the detailed text of consent/assent procedures here.
Inclusion criteria
- {"criterion_text":"- Histologically or cytologically confirmed ES-SCLC (per the VALG staging system)\n- Adequate hematologic and end-organ function\n- ECOG PS 0 or 1\n- No prior systemic treatment for ES-SCLC\n- Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy\n- Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better"}
Exclusion criteria
- {"criterion_text":"- Presence or history of CNS metastases\n- Planned consolidative chest radiation\n- Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures\n- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin\n- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n- Disease progression following induction treatment"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. IRF-assessed progression-free survival (PFS) after randomization, defined as the time from randomization to the date of first occurrence of documented disease progression (as assessed by the IRF according to RECIST v1.1), or death from any cause (whichever occurs first)","definition_or_measurement_approach":"Defined as the time from randomization to the date of first occurrence of documented disease progression as assessed by the Independent Review Facility (IRF) according to RECIST v1.1, or death from any cause (whichever occurs first)."}
- {"endpoint_text":"- 2. Overall Survival after randomization, defined as the time from randomization to the date of death from any cause","definition_or_measurement_approach":"Defined as the time from randomization to the date of death from any cause."}
Secondary endpoints
- {"endpoint_text":"- 1. Investigator-assessed progression-free survival (PFS)","definition_or_measurement_approach":"Investigator-assessed PFS (measurement per RECIST v1.1 as assessed by investigator)."}
- {"endpoint_text":"- 2. Confirmed objective response rate (ORR) as determined by the IRF and investigator according to RECIST v1.1","definition_or_measurement_approach":"Confirmed ORR determined by IRF and investigator per RECIST v1.1."}
- {"endpoint_text":"- 3. Duration of response (DOR) as determined by the IRF and investigator according to RECIST v1.1","definition_or_measurement_approach":"DOR as determined by IRF and investigator per RECIST v1.1."}
- {"endpoint_text":"- 4. PFS rates at 6 months and 12 months as determined by the IRF and investigator according to RECIST v1.1","definition_or_measurement_approach":"PFS rates at specified time points determined by IRF and investigator per RECIST v1.1."}
- {"endpoint_text":"- 5. OS rates at 12 months and 24 months","definition_or_measurement_approach":"Overall survival rates at 12 and 24 months from randomization."}
- {"endpoint_text":"- 6. Incidence and severity of adverse events, including serious adverse events and adverse events of special interest in randomized participants, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0","definition_or_measurement_approach":"Safety assessed by incidence and severity of adverse events, graded per NCI CTCAE v5.0."}
- {"endpoint_text":"- 7. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at induction phase baseline and incidence of ADAs to atezolizumab after drug administration by treatment group","definition_or_measurement_approach":"Immunogenicity measured by prevalence and incidence of anti-drug antibodies to atezolizumab across treatment groups."}
- {"endpoint_text":"- 8. Time to confirmed deterioration (TTCD) from randomization in patient reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC QLQ-C30; TTCD assessed from randomization to confirmed deterioration in specified domains."}
Recruitment
- Planned Sample Size
- 326
- Recruitment Window Months
- 53
- Consent Approach
- Subject information sheets and informed consent forms are provided; multiple language versions and age/vulnerable-population specific consent materials are included in the submission (examples: English, French, Dutch, German, Spanish, Polish, Italian, Hungarian, Greek — evidenced by document filenames such as 'L1_SIS and ICF Main ICF_EN_REDACTED', 'L1_SIS and ICF RBR_FR_REDACTED', 'D1_Protocol Synopsis_IT', 'D1_Protocol Synopsis_HU', etc.). Age-specific and vulnerable-population documents are included (e.g. 'L1_SIS and ICF Infant', 'L1__Infant_AF', 'L1_Pregnant_Partner_SIS_ICF_sanitized'). The CTIS record does not provide the full verbatim consent procedure text here (who signs on behalf of infants or exact assent process is not included in the exported JSON).
Geography
- Total Number Of Sites
- 47
- Total Number Of Participants
- 332
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 678
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- A.Z. Sint-Maarten
- Department Name
- Respiratory Oncology
- Contact Person Name
- Marc Lambrechts
- Contact Person Email
- marc.lambrechts@emmaus.be
- Site Name
- UZ Leuven
- Department Name
- Pneumology, Respiratory Oncology
- Contact Person Name
- Els Wauters
- Contact Person Email
- els.wauters@uzleuven.be
- Site Name
- Vitaz
- Department Name
- Pulmonary
- Contact Person Name
- Charlotte Van De Kerkhove
- Contact Person Email
- Charlotte.VandeKerkhove@vitaz.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Pulmonary Division
- Contact Person Name
- Sebahat Ocak
- Contact Person Email
- sebahat.ocak@uclouvain.be
- Site Name
- Institut Jules Bordet
- Department Name
- Medical Oncology
- Contact Person Name
- Mariana Brandao
- Contact Person Email
- mariana.brandao@hubruxelles.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Oncology
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- kristof.cuppens@jessazh.be
Italy
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 678
- Number Of Sites
- 8
- Number Of Participants
- 17
Sites
- Site Name
- Azienda Sociosanitaria 3
- Department Name
- ASL 3 Genovese
- Contact Person Name
- Paola Taveggia
- Contact Person Email
- segreteria.contratticonvenzioni@asl3.ligurua.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
- Contact Person Name
- Ester Del Signore
- Contact Person Email
- filippo.demarinis@ieo.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
- Contact Person Name
- Manolo D'Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
- Contact Person Name
- Manolo D'Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
- Contact Person Name
- Diego Signorelli
- Contact Person Email
- diego.signorelli@ospedaleniguarda.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
- Contact Person Name
- Manolo D'Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- rossana.berardi@ospedaliriuniti.marche.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
- Contact Person Name
- Manolo D'Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
Greece
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 679
- Number Of Sites
- 5
- Number Of Participants
- 41
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Department of Internal Medicine/ Oncology Unit
- Contact Person Name
- Konstantinos Syrigos
- Contact Person Email
- ksyrigos.trials@gmail.com
- Site Name
- St. Luke's Hospital S.A.
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Georgios Fountzilas
- Contact Person Email
- fountzil@auth.gr
- Site Name
- General University Hospital Of Larissa
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Athanasios Kotsakis
- Contact Person Email
- thankotsakis@hotmail.com
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Clinic of Oncology
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 680
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- University Of Pecs
- Department Name
- Onkoterapias Intezet
- Contact Person Name
- Arpad Boronkai
- Contact Person Email
- arpad.boronkai@gmail.hu
- Site Name
- Reformatus Pulmonologiai Centrum
- Department Name
- VI. Osztaly
- Contact Person Name
- Gabriella Galffy
- Contact Person Email
- galffy.gabriella@torokbalintkorhaz.hu
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Onkologiai Osztaly
- Contact Person Name
- Anikó Ragályi
- Contact Person Email
- aniko.ragalyi@freemail.hu
- Site Name
- Orszagos Koranyi Pulmonologiai Intezet
- Department Name
- XIV. Pulmonologiai Osztaly
- Contact Person Name
- Gabriella Temesi
- Contact Person Email
- temesi@koranyi.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 680
- Number Of Sites
- 6
- Number Of Participants
- 100
Sites
- Site Name
- Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
- Department Name
- Oddział III Chorób Płuc
- Contact Person Name
- Aleksandra Szczęsna
- Contact Person Email
- ola_szczesna@outlook.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Contact Person Name
- Adam Płużański
- Contact Person Email
- malgorzata.falgowska@nio.gov.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddział onkologii z pododdziałem chemioterapii
- Contact Person Name
- Andrzej Każarnowicz
- Contact Person Email
- sekretariat@pulmonologia.olsztyn.pl
- Site Name
- Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
- Contact Person Name
- Katarzyna Stencel
- Contact Person Email
- kstencel@wcpit.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
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej
- Contact Person Name
- Grzegorz Czyżewicz
- Contact Person Email
- czyzeg@szpitaljp2.krakow.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 678
- Number Of Sites
- 9
- Number Of Participants
- 66
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Reyes Bernabé Caro
- Contact Person Email
- reyesbernab@yahoo.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Contact Person Name
- M.Rosario García Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Pedro Filipe Simões da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Contact Person Name
- José Carlos Benítez Montañez
- Contact Person Email
- jcbenitez.huvv@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Contact Person Name
- Edurne Arriola Aperribay
- Contact Person Email
- earriola@psmar.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Luis Paz-Ares
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Universitari Vall D Hebron (additional site entry)
- Department Name
- Oncology
- Contact Person Name
- Pedro Filipe Simões da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Complexo Hospitalario Universitario A Coruna (additional site entry)
- Department Name
- Oncology
- Contact Person Name
- M.Rosario García Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
Germany
- Earliest CTIS Part Ii Submission Date
- 19-06-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 677
- Number Of Sites
- 9
- Number Of Participants
- 65
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Medizinische Klinik III, Studienzentrum Pneumologie - Onkologie
- Contact Person Name
- Sabine Bohnet
- Contact Person Email
- Sabine.Bohnet@uksh.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Department Name
- Klinische Forschung Onkologie
- Contact Person Name
- Martin Reck
- Contact Person Email
- a.gaebler@lungenclinic.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Klinik für Pneumologie, Thorakale Onkologie
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- studien.gauting@asklepios.com
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Innere Medizin IV, Onkologie
- Contact Person Name
- Stefan Hammerschmidt
- Contact Person Email
- s.hammerschmidt@skc.de
- Site Name
- HELIOS Klinikum Emil von Behring GmbH
- Department Name
- Klinik für Pneumologie
- Contact Person Name
- Daniel Misch
- Contact Person Email
- daniel.misch@helios-gesundheit.de
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- Klinik für Pneumologie
- Contact Person Name
- Christian Grohé
- Contact Person Email
- sekr.pneumologie.lungenklinik@pgdiakonie.de
- Site Name
- Martha-Maria Krankenhaus Halle-Doelau gGmbH
- Department Name
- Klinik für Innere Medizin II
- Contact Person Name
- Wolfgang Schütte
- Contact Person Email
- wolfgang.schuette@martha-maria.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Internistische Onkologie/Hämatologie mit Integrierter Palliativmedizin
- Contact Person Name
- Sebastian Ertl
- Contact Person Email
- onkologie@kem-med.com
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (additional entry)
- Department Name
- Medizinische Klinik III, Studienzentrum Pneumologie - Onkologie
- Contact Person Name
- Sabine Bohnet
- Contact Person Email
- Sabine.Bohnet@uksh.de
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Swm Partners Limited
- Responsibilities
- Meeting Organizer
- Name
- Greenphire LLC
- Responsibilities
- Patient Reimbursement
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- Randomization
- Name
- Transperfect Translations International Inc.
- Responsibilities
- Translations
- Name
- Kayentis
- Responsibilities
- Electronic Clinical Outcome Assessment
- Name
- Bioclinica Inc.
- Responsibilities
- Independent Radiology Coordinator
Third parties
- {"country":"United Kingdom","full_name":"Swm Partners Limited","duties_or_roles":"Meeting Organizer","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Spain","full_name":"Atrys Health S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Randomization","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"Electronic Clinical Outcome Assessment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Independent Radiology Coordinator","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC (duplicate entry in thirdParties list)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- Atezolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV infusion
- Route
- IV INFUSION
- Authorisation Status
- Authorised (marketing authorisation EU/1/17/1220/001 indicated in record)
- Starting Dose
- 1200 mg
- Maximum Dose
- 1200 mg (maxDailyDoseAmount), max total amount 40.8 g (as provided in product data)
- Investigational Product Name
- Lurbinectedin (LURBINECTEDIN / RO7508182)
- Active Substance
- Lurbinectedin
- Modality
- Small molecule
- Routes Of Administration
- IV infusion
- Route
- IV INFUSION
- Starting Dose
- 3.2 mg/m2
- Maximum Dose
- Max total amount 96 mg/m2 (as provided in product data)
- Combination Treatment
- Yes
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