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New drug combo aims to keep aggressive lung cancer at bay longer

NCT ID NCT05091567

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether adding lurbinectedin to atezolizumab as maintenance therapy helps people with extensive-stage small-cell lung cancer live longer without the disease worsening. Participants first receive standard induction chemo-immunotherapy, then those with stable or responding disease are randomly assigned to get either the combination or atezolizumab alone. The study involves 660 adults across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lurbinectedin and atezolizumab
What this could lead to
If successful, this combination could extend the time before the cancer worsens and improve survival for people with extensive-stage small-cell lung cancer.
What could go wrong
This is a late-stage trial, but adding a second drug may increase side effects without guaranteeing better outcomes. The cancer is aggressive and often returns despite treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

660 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer

Contacts and locations

Locations

  • ASL 3 Genovese

    Genoa, Liguria, 16125, Italy

  • AUSL della Romagna

    Ravenna, Emilia-Romagna, 48121, Italy

  • AZ St Maarten Campus Leopoldstr

    Mechelen, 2800, Belgium

  • Ac?badem Altunizade Hastanesi

    Istanbul, 34660, Turkey (Türkiye)

  • Ag. Loukas Hospital

    Thessaloniki, 55236, Greece

  • Ankara Bilkent City Hospital

    Ankara, 06490, Turkey (Türkiye)

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Morelia, 58260, Mexico

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Klinik Gauting

    München-Gauting, 82131, Germany

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette Di Ancona, The Marches, 60126, Italy

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    Milan, Lombardy, 20162, Italy

  • Ba?c?lar Medipol Mega Üniversite Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR, United Kingdom

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530, Belgium

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503, United States

  • Castle Hill Hospital

    Hull, HU16 5JQ, United Kingdom

  • Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-781, Poland

  • Chilgok Kyungpook National University Medical Center

    Daegu, 702-210, South Korea

  • Christie NHS Foundation Trust

    GB Manchester, M20 4BX, United Kingdom

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinical Research Alliance

    Westbury, New York, 11590, United States

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006, Spain

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Diavalkaniko Hospital

    Thessaloniki, 570 01, Greece

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280, Turkey (Türkiye)

  • E-DA Hospital

    Kaohsiung City, 824, Taiwan

  • Errikos Dynan Hospital

    Athens, 11526, Greece

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 546 45, Greece

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125, Germany

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376, Germany

  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital

    Kadiköy, 34722, Turkey (Türkiye)

  • Greco-Hainesworth Centers for Research

    Chattanooga, Tennessee, 37403, United States

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Gyeongsang National University Hospital

    Gyeongsangnam-do, 52727, South Korea

  • Gülhane E?itim Ve Ara?t?rma Hastanesi

    Ankara, 06010, Turkey (Türkiye)

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165, Germany

  • Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital

    Istanbul, 34300, Turkey (Türkiye)

  • Izmir Medical Point Hospital

    Izmir, 35101, Turkey (Türkiye)

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

    Szolnok, 5000, Hungary

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500, Belgium

  • KEM/Evang. Kliniken Essen Mitte gGmbH

    Essen, 45136, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Kocaeli University Faculty of Medicine

    İzmit, 31380, Turkey (Türkiye)

  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

    Krakow, 31-202, Poland

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120, Germany

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Liv Hospital Ankara

    Ankara, 06680, Turkey (Türkiye)

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927, Germany

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400, Poland

  • Medikal Park Samsun

    Samsun, 55200, Turkey (Türkiye)

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • National Cheng Kung University Hospital

    Tainan, 00704, Taiwan

  • New England Cancer Specialists

    Scarborough, Maine, 04074, United States

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124, Germany

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Marietta, Georgia, 30060, United States

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest, 1121, Hungary

  • Pamukkale University School Of Medicine

    Denizli, 20070, Turkey (Türkiye)

  • Pécsi Tudományegyetem

    Pécs, 7623, Hungary

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Samsung Changwon Hospital

    Gyeongsangnam-do, 51353, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, 115 27, Greece

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • TC Necmettin Erbakan University Meram Medical Faculty Hospital

    Selçuklu, 42080, Turkey (Türkiye)

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The Mark H. Zangmeister Ctr

    Columbus, Ohio, 43219, United States

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030, Turkey (Türkiye)

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045, Hungary

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Ulsan University Hosiptal

    Ulsan, 44033, South Korea

  • Uludag Uni Hospital

    Bursa, 16059, Turkey (Türkiye)

  • University Hospital of Larissa

    Larissa, 411 10, Greece

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Vitaz

    Sint-Niklaas, 9100, Belgium

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357, Poland

  • West Clinic

    Germantown, Tennessee, 38138, United States

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569, Poland

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.