Small-Cell Lung Cancer Clinical Trial
— IMforteOfficial 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
Verified date | June 2024 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 690 |
Est. completion date | March 6, 2026 |
Est. primary completion date | April 18, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Anderlecht | |
Belgium | Jessa Zkh (Campus Virga Jesse) | Hasselt | |
Belgium | UZ Leuven Gasthuisberg | Leuven | |
Belgium | AZ St Maarten Campus Leopoldstr | Mechelen | |
Belgium | CHU UCL Mont-Godinne | Mont-godinne | |
Belgium | Vitaz | Sint Niklaas | |
Germany | Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie | Bad Berka | |
Germany | Evang. Lungenklinik Berlin Klinik für Pneumologie | Berlin | |
Germany | Helios Klinikum Emil von Behring GmbH | Berlin | |
Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
Germany | KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie | Essen | |
Germany | Asklepios Klinik Gauting; Onkologisches Studienzentrum | Gauting | |
Germany | Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH | Georgsmarienhütte | |
Germany | LungenClinic Großhansdorf GmbH; Klinische Forschung | Großhansdorf | |
Germany | Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II | Halle | |
Germany | KRH Klinikum Siloah-Oststadt-Heidehaus | Hannover | |
Germany | Fachklinik für Lungenerkrankungen | Immenhausen | |
Germany | Universitätsklinikum Schleswig-Holstein; Campus Lübeck | Lübeck | |
Germany | Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie | Regensburg | |
Greece | ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINIC | Athens | |
Greece | Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology Clinic | Athens | |
Greece | University Hospital of Larissa;Department of Medical Oncology | Larissa | |
Greece | Diavalkaniko Hospital | Thessaloniki | |
Greece | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | |
Hungary | Orszagos Koranyi Pulmonologiai Intezet | Budapest | |
Hungary | Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | |
Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. | Szolnok | |
Hungary | Tudogyogyintezet Torokbalint | Torokbalint | |
Italy | ASL 3 Genovese | Genova | Liguria |
Italy | Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck | Milano | Lombardia |
Italy | Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia | Milano | Lombardia |
Italy | AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia | Ravenna | Emilia-Romagna |
Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti | Torrette Di Ancona | Marche |
Korea, Republic of | Chungbuk National University Hospital | Cheongju si | |
Korea, Republic of | Chilgok Kyungpook National University Medical Center | Daegu | |
Korea, Republic of | Gyeongsang National University Hospital | Gyeongsangnam-do | |
Korea, Republic of | Samsung Changwon Hospital | Gyeongsangnam-do | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Ulsan University Hosiptal | Ulsan | |
Mexico | Health Pharma Professional Research | Cdmx | Mexico CITY (federal District) |
Mexico | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco |
Poland | Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | |
Poland | Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny | Kraków | |
Poland | Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii | Olsztyn | |
Poland | Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc | Otwock | |
Poland | Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej | Poznan | |
Poland | Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej | Warszawa | |
Spain | Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia | A Coruña | LA Coruña |
Spain | Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | |
Spain | Hospital del Mar; Servicio de Oncologia | Barcelona | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
Spain | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Malaga | |
Spain | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Sant Andreu de La Barca | Barcelona |
Spain | Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Sevilla | |
Taiwan | E-DA Hospital; Chest | Kaohsiung | |
Taiwan | Taichung Veterans General Hospital; Dept of Internal Medicine | Taichung | |
Taiwan | National Cheng Kung University Hospital; Oncology | Tainan | |
Taiwan | Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology | Taipei | |
Turkey | Adana Baskent University Hospital; Medical Oncology | Adana | |
Turkey | Ankara City Hospital; Oncology | Ankara | |
Turkey | Gülhane E?itim Ve Ara?t?rma Hastanesi | Ankara | |
Turkey | Liv Hospital Ankara; Medical Oncology | Ankara | |
Turkey | Memorial Ankara Hastanesi | Ankara | |
Turkey | Uludag Uni Hospital; Oncology | Bursa | |
Turkey | Pamukkale University School Of Medicine; Oncology Department | Denizli | |
Turkey | Dicle University Faculty of Medicine | Diyarbakir | |
Turkey | Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | |
Turkey | Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology | Istanbul | |
Turkey | Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | |
Turkey | ?zmir Medical Park; Onkoloji | Izmir | |
Turkey | Kocaeli University Faculty of Medicine; Medical oncology | Izmit | |
Turkey | Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology | Kadiköy | |
Turkey | Medikal Park Samsun | Samsun | |
Turkey | TC Necmettin Erbakan University Meram Medical Faculty Hospital | Selçuklu | |
Turkey | Ac?badem Altunizade Hastanesi; Oncology | Üsküdar | |
United Kingdom | Ysbyty Gwynedd Hospital | Bangor | |
United Kingdom | Blackpool Victoria Hospital | Blackpool | |
United Kingdom | Western General Hospital; Edinburgh Cancer Center | Edinburgh | |
United Kingdom | Christie NHS Foundation Trust | GB Manchester | |
United Kingdom | Castle Hill Hospital; The Queen's Centre for Oncology & Haematology | Hull | |
United Kingdom | St James University Hospital | Leeds | |
United Kingdom | Leicester Royal Infirmary | Leicester | |
United Kingdom | Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office | London | |
United Kingdom | University College London Hospital | London | |
United States | Hematology Oncology Clinic | Baton Rouge | Louisiana |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Hollings Cancer Center | Charleston | South Carolina |
United States | Greco-Hainesworth Centers for Research; ETN (East Tennessee) | Chattanooga | Tennessee |
United States | The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. | Columbus | Ohio |
United States | Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida |
United States | West Clinic | Germantown | Tennessee |
United States | Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy | Grand Rapids | Michigan |
United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
United States | Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia |
United States | SCRI Oncology Partners | Nashville | Tennessee |
United States | Illinois Cancer Care | Peoria | Illinois |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Mercy Research - St. Louis | Saint Louis | Missouri |
United States | Florida Cancer Specialist, North Region | Saint Petersburg | Florida |
United States | Mays Cancer Center at UT Health San Antonio MD Anderson Cancer | San Antonio | Texas |
United States | New England Cancer Specialists | Scarborough | Maine |
United States | Mercy Research SPRG | Springfield | Missouri |
United States | SCRI Florida Cancer Specialists PAN | Tallahassee | Florida |
United States | Florida Cancer Specialists | West Palm Beach | Florida |
United States | Clinical Research Alliance | Westbury | New York |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche | Jazz Pharmaceuticals |
United States, Belgium, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Poland, Spain, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IRF-Assessed Progression-Free Survival (PFS) | IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the date of first documented disease progression (as assessed by the IRF according to RECIST v1.1), or death whichever occurs first. | Randomization to the date of first documented disease progression or death, whichever occurs first (up to approximately 60 months) | |
Primary | Overall Survival (OS) | Overall survival (OS) is defined as the time from randomization to the date of death from any cause. | Randomization to the date of death from any cause (up to approximately 60 months) | |
Secondary | Investigator-Assessed PFS | Investigator-assessed PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). | Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 60 months) | |
Secondary | Confirmed Objective Response Rate (ORR) as Determined by the IRF | Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions >= 4 weeks apart after randomization, as determined by the IRF according to RECIST v1.1. | Up to approximately 60 months | |
Secondary | Confirmed Objective Response Rate (ORR) as Determined by the Investigator | Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions >= 4 weeks apart after randomization, as determined by the Investigator according to RECIST v1.1. | Up to approximately 60 months | |
Secondary | Duration of Response (DOR) as Determined by the IRF | Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the IRF according to RECIST v1.1, or death from any cause, whichever occurs first. | Up to approximately 60 months | |
Secondary | Duration of Response (DOR) as Determined by the Investigator | Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. | Up to approximately 60 months | |
Secondary | PFS Rates as Determined by the IRF | PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the IRF according to RECIST v1.1. | 6 months and 12 months after randomization | |
Secondary | PFS Rates as Determined by the Investigator | PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the investigator according to RECIST v1.1. | 6 months and 12 months after randomization | |
Secondary | OS Rates | OS rates at 12 months and 24 months is defined as the proportion of participants who have not experienced death from any cause at 12 months and 24 months after randomization. | 12 months and 24 months after randomization | |
Secondary | Percentage of Participants With Adverse Events | Percentage of participants with adverse events. | Up to approximately 60 months | |
Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Percentage of participants with ADAs to atezolizumab after drug administration. | Up to approximately 60 months | |
Secondary | Time to Confirmed Deterioration (TTCD) | Time to confirmed deterioration (TTCD) from randomization in participant-reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). | Up to approximately 60 months |
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