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
IMforte
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
2 other identifiers
interventional
660
13 countries
96
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2021
Longer than P75 for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2024
CompletedResults Posted
Study results publicly available
December 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2026
ExpectedMarch 10, 2026
March 1, 2026
2.7 years
October 12, 2021
November 21, 2025
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS)
PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
Up to 26 months
Randomized Phase: Overall Survival (OS)
OS was defined as the time from randomization to the date of death from any cause.
Up to 26 months
Secondary Outcomes (11)
Randomized Phase: Investigator-assessed PFS
Up to 26 months
Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF
Up to 26 months
Randomized Phase: Confirmed ORR as Determined by the Investigator
Up to 26 months
Randomized Phase: Duration of Response (DOR) as Determined by the IRF
Up to 26 months
Randomized Phase: DOR as Determined by the Investigator
Up to 26 months
- +6 more secondary outcomes
Study Arms (2)
Arm A: Atezolizumab+Lurbinectedin
EXPERIMENTALInduction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.
Arm B: Atezolizumab
ACTIVE COMPARATORInduction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.
Interventions
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Jazz Pharmaceuticalscollaborator
Study Sites (96)
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, 30060, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Mercy Research - St. Louis
St Louis, Missouri, 63141, United States
Clinical Research Alliance
Westbury, New York, 11590, United States
The Mark H. Zangmeister Ctr
Columbus, Ohio, 43219, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Greco-Hainesworth Centers for Research
Chattanooga, Tennessee, 37403, United States
West Clinic
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203, United States
Institut Jules Bordet
Anderlecht, 1070, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
AZ St Maarten Campus Leopoldstr
Mechelen, 2800, Belgium
CHU UCL Mont-Godinne
Mont-godinne, 5530, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, 13125, Germany
Helios Klinikum Emil von Behring GmbH
Berlin, 14165, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, 45136, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120, Germany
Fachklinik für Lungenerkrankungen
Immenhausen, 34376, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Asklepios Klinik Gauting
München-Gauting, 82131, Germany
Sotiria Thoracic Diseases Hospital of Athens
Athens, 115 27, Greece
Errikos Dynan Hospital
Athens, 11526, Greece
University Hospital of Larissa
Larissa, 411 10, Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, 546 45, Greece
Ag. Loukas Hospital
Thessaloniki, 55236, Greece
Diavalkaniko Hospital
Thessaloniki, 570 01, Greece
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121, Hungary
Pécsi Tudományegyetem
Pécs, 7623, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok, 5000, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
AUSL della Romagna
Ravenna, Emilia-Romagna, 48121, Italy
ASL 3 Genovese
Genoa, Liguria, 16125, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, 20141, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, 20162, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona, The Marches, 60126, Italy
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Morelia, 58260, Mexico
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214, Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow, 31-202, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, 10-357, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, 05-400, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, 60-569, Poland
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Chilgok Kyungpook National University Medical Center
Daegu, 702-210, South Korea
Samsung Changwon Hospital
Gyeongsangnam-do, 51353, South Korea
Gyeongsang National University Hospital
Gyeongsangnam-do, 52727, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, 15006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
E-DA Hospital
Kaohsiung City, 824, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 00704, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Adana Baskent University Hospital
Adana, 01120, Turkey (Türkiye)
Gülhane E?itim Ve Ara?t?rma Hastanesi
Ankara, 06010, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
Uludag Uni Hospital
Bursa, 16059, Turkey (Türkiye)
Pamukkale University School Of Medicine
Denizli, 20070, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, 21280, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030, Turkey (Türkiye)
Ba?c?lar Medipol Mega Üniversite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital
Istanbul, 34300, Turkey (Türkiye)
Ac?badem Altunizade Hastanesi
Istanbul, 34660, Turkey (Türkiye)
Izmir Medical Point Hospital
Izmir, 35101, Turkey (Türkiye)
Kocaeli University Faculty of Medicine
İzmit, 31380, Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, 34722, Turkey (Türkiye)
Medikal Park Samsun
Samsun, 55200, Turkey (Türkiye)
TC Necmettin Erbakan University Meram Medical Faculty Hospital
Selçuklu, 42080, Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Christie NHS Foundation Trust
GB Manchester, M20 4BX, United Kingdom
Castle Hill Hospital
Hull, HU16 5JQ, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, Majem M, Sendur MAN, Czyzewicz G, Caro RB, Lee KH, Johnson ML, Karadurmus N, Grohe C, Baka S, Csoszi T, Ahn JS, Califano R, Yang TY, Kemal Y, Ballinger M, Cuchelkar V, Graupner V, Lin YC, Chakrabarti D, Bhatt K, Cai G, Iannone R, Reck M; IMforte investigators. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 14;405(10495):2129-2143. doi: 10.1016/S0140-6736(25)01011-6. Epub 2025 Jun 2.
PMID: 40473449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 25, 2021
Study Start
November 18, 2021
Primary Completion
July 29, 2024
Study Completion (Estimated)
August 13, 2026
Last Updated
March 10, 2026
Results First Posted
December 29, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing