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New hope for lung cancer: could tobemstomig beat current standard?

NCT ID NCT05775289

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study compares a new drug, tobemstomig, combined with chemotherapy against the current standard treatment (pembrolizumab plus chemo) for people with advanced non-small cell lung cancer that has not been treated before. The goal is to see if the new combination works better at delaying cancer growth or shrinking tumors. About 182 participants will take part, and the study is currently active but no longer recruiting.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

182 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2026

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: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically documented locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative surgery and/or definitive chemoradiotherapy * No prior systemic treatment for metastatic NSCLC * Known tumor PD-L1 status * Confirmed availability of representative tumor specimens * Measurable disease * Life expectancy of at least 12 weeks * Adequate hematologic and end-organ function * Negative for HIV, hepatitis B (HBV), and hepatitis C (HCV) * Adequate cardiovascular function Exclusion Criteria: * NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Untreated or clinically unstable spinal cord confession * History of leptomeningeal disease * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently) * Uncontrolled or symptomatic hypercalcemia * Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with exceptions defined by the protocol * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography (CT) scan * Active tuberculosis (TB) or untreated latent TB * Current treatment with anti-viral therapy for HBV or HCV * Significant cardiovascular disease within 3 months prior to randomization * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death e.g., 5-year OS\] rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer * Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could affect patient safety * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment * Prior allogeneic stem cell or solid organ transplantation * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Any anti-cancer therapy, including hormonal therapy, within 21 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-cytotoxic T lymphocyte-associated protein 4, anti-T cell immunoreceptor with Ig and tyrosine-based inhibition motif domains, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and anti-LAG3) agents * Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 drug-elimination half lives (whichever is longer) prior to initiation of study treatment * Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[TNF\] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies, fusion proteins, or platinum-containing compounds * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tobemstomig or pembrolizumab formulation * Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the patient may receive during the study * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer

Contacts and locations

Locations

  • ?zmir Medical Park

    Izm?r, 35575, Turkey (Türkiye)

  • AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V

    Mexico City, Mexico CITY (federal District), 07300, Mexico

  • AZ St Maarten Campus Leopoldstr

    Mechelen, 2800, Belgium

  • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

    Bologna, Emilia-Romagna, 40138, Italy

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Di Monza

    Monza, Lombardy, 20900, Italy

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Campania, 83100, Italy

  • Barwon Health

    Geelong, Victoria, 3220, Australia

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31100, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006, Spain

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550, Brazil

  • Henry Ford Health System

    Detroit, Michigan, 48202-2689, United States

  • Hopital Cochin

    Paris, 75679, France

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29011, Spain

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, Rio Grande do Sul, Brazil

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • IRCCS AOU San Martino - IST

    Genoa, Liguria, 16132, Italy

  • Ico Rene Gauducheau

    Saint-Herblain, 44805, France

  • Institut Catala d Oncologia Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080, Mexico

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500, Belgium

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Krankenhaus Martha-Maria Halle-Doelau

    Halle, 06120, Germany

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927, Germany

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Lyell McEwin Hospital

    Adelaide, South Australia, 5112, Australia

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Monash Health

    Melbourne, Victoria, 3168, Australia

  • Nucleo de Oncologia da Bahia - NOB

    Salvador, Bahia, Estado de Bahia, 40170-380, Brazil

  • ONCARE Viaducto Napoles

    Mexico City, Mexico CITY (federal District), 03810, Mexico

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168, Italy

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Renown Regional Medical Center Hospital

    Reno, Nevada, 89502-1576, United States

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126, Germany

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

    Edirne, 22030, Turkey (Türkiye)

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Uniklinik Essen

    Essen, 45122, Germany

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

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