Clinical trial NCT05091567: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
Official title: A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Small-Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Jazz Pharmaceuticals
First posted: 2021-10-25
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.


Eligibility criteria: Inclusion Criteria for the Induction Phase:

* ECOG PS of 0 or 1
* No prior systemic therapy for ES-SCLC
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* Histologically or cytologically confirmed ES-SCLC
* Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
* Measurable disease, as defined by RECIST v1.1
* Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening

Exclusion Criteria for the Induction Phase:

* Presence or history of CNS metastases
* Active or history of autoimmune disease or deficiency
* History of malignancies other than SCLC within 5 years prior to enrollment
* 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
* 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
* Treatment with investigational therapy within 28 days prior to enrollment

Inclusion Criteria for the Maintenance Phase:

* ECOG PS of 0 or 1
* Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
* Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade \<=1
* Adequate hematologic and end-organ function

Exclusion Criteria for the Maintenance Phase:

* Presence or history of CNS metastases
* Receiving consolidative chest radiation
* Severe infection within 2 weeks prior to randomization into the maintenance
* Treatment with therapeutic oral or IV antibiotics at the time of randomization

Primary outcomes:
measure: IRF-Assessed Progression-Free Survival (PFS)
timeFrame: Randomization to the date of first documented disease progression or death, whichever occurs first (up to approximately 60 months)
measure: Overall Survival (OS)
timeFrame: Randomization to the date of death from any cause (up to approximately 60 months)
Secondary outcomes:
measure: Investigator-Assessed PFS
timeFrame: Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 60 months)
measure: Confirmed Objective Response Rate (ORR) as Determined by the IRF
timeFrame: Up to approximately 60 months
measure: Confirmed Objective Response Rate (ORR) as Determined by the Investigator
timeFrame: Up to approximately 60 months
measure: Duration of Response (DOR) as Determined by the IRF
timeFrame: Up to approximately 60 months
measure: Duration of Response (DOR) as Determined by the Investigator
timeFrame: Up to approximately 60 months
measure: PFS Rates as Determined by the IRF
timeFrame: 6 months and 12 months after randomization
measure: PFS Rates as Determined by the Investigator
timeFrame: 6 months and 12 months after randomization
measure: OS Rates
timeFrame: 12 months and 24 months after randomization
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 60 months
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
timeFrame: Up to approximately 60 months
measure: Time to Confirmed Deterioration (TTCD)
timeFrame: Up to approximately 60 months
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Research - St. Louis
state: Missouri
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Columbus
country: United States
facility: The Mark H. Zangmeister Ctr
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Chattanooga
country: United States
facility: Greco-Hainesworth Centers for Research
state: Tennessee
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Mechelen
country: Belgium
facility: AZ St Maarten Campus Leopoldstr
city: Mont-godinne
country: Belgium
facility: CHU UCL Mont-Godinne
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Evang. Lungenklinik Berlin Klinik für Pneumologie
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring GmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Essen
country: Germany
facility: KEM/Evang. Kliniken Essen Mitte gGmbH
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: München-Gauting
country: Germany
facility: Asklepios Klinik Gauting
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
city: Athens
country: Greece
facility: Errikos Dynan Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Diavalkaniko Hospital
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Ravenna
country: Italy
facility: AUSL della Romagna
state: Emilia-Romagna
city: Genova
country: Italy
facility: ASL 3 Genovese
state: Liguria
city: Milano
country: Italy
facility: Irccs Istituto Europeo di Oncologia (IEO)
state: Lombardia
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
state: Lombardia
city: Torrette Di Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
state: Marche
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Chilgok Kyungpook National University Medical Center
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Morelia
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
city: Olsztyn
country: Poland
facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
state: LA Coruna
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Adana
country: Turkey
facility: Adana Baskent University Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Bursa
country: Turkey
facility: Uludag Uni Hospital
city: Denizli
country: Turkey
facility: Pamukkale University School Of Medicine
city: Diyarbakir
country: Turkey
facility: Dicle University Faculty of Medicine
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Istanbul
country: Turkey
facility: Ba?c?lar Medipol Mega Üniversite Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Ac?badem Altunizade Hastanesi
city: Izmir
country: Turkey
facility: Izmir Medical Point Hospital
city: Izmit
country: Turkey
facility: Kocaeli University Faculty of Medicine
city: Kadiköy
country: Turkey
facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital
city: Samsun
country: Turkey
facility: Medikal Park Samsun
city: Selçuklu
country: Turkey
facility: TC Necmettin Erbakan University Meram Medical Faculty Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: GB Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: