A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Study summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTobemstomig and Pembrolizumab

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 20, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?50 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Hoffmann-La Roche
Interventions being studied: Drug: Tobemstomig; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→Radiation therapy→Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Henry Ford Health SystemDetroit, Michigan
Renown Regional Medical Center HospitalReno, Nevada
Westmead HospitalWestmead, New South Wales
Lyell McEwin HospitalAdelaide, South Australia
Barwon HealthGeelong, Victoria
Monash HealthMelbourne, Victoria
UZ BrusselBrussels
Jessa Zkh (Campus Virga Jesse)Hasselt
UZ Leuven GasthuisbergLeuven
AZ St Maarten Campus LeopoldstrMechelen
Crio - Centro Regional Integrado de OncologiaFortaleza, Ceará
Nucleo de Oncologia da Bahia - NOBSalvador, Bahia, Estado de Bahia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2026. Always confirm current availability with the study team.

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