Lung Cancer Clinical Trial

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

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT05775289

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 59 Locations for this study

See Locations Near You

Mitchell Cancer Institute; Pharmacy
Mobile Alabama, 36604, United States
Henry Ford Health System; Hematology/Oncology
Detroit Michigan, 48202, United States
Renown Regional Medical Center Hospital
Reno Nevada, 89502, United States
Cooper Health System; MD Anderson Cancer Center
Camden New Jersey, 08103, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Virginia Commonwealth University Medical Center Main Hospital
Richmond Virginia, 23298, United States
Westmead Hospital
Westmead New South Wales, 2145, Australia
Lyell McEwin Hospital
Adelaide South Australia, 5112, Australia
Monash Health
Clayton Victoria, 3168, Australia
Barwon Health
Geelong Victoria, 3220, Australia
UZ Brussel
Brussel , 1090, Belgium
GHdC Site Notre Dame
Charleroi , 6000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt , 3500, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
AZ St Maarten Campus Leopoldstr
Mechelen , 2800, Belgium
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia BA, 40170, Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza CE, 60336, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 90040, Brazil
Hospital de Clínicas de Porto Alegre X
Porto Alegre RS, , Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Ottawa Hospital Research Institute
Ottawa Ontario, K1Y 4, Canada
Windsor Regional Hospital
Windsor Ontario, N8W 1, Canada
Hopital Jean Minjoz; Pneumologie
Besancon , 25030, France
Centre Leon Berard
Lyon , 69008, France
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris , 75014, France
Ico Rene Gauducheau; Oncologie
Saint Herblain , 44805, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg , 67065, France
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Toulouse cedex 9 , 31100, France
Uniklinik Essen
Essen , 45122, Germany
LungenClinic Großhansdorf GmbH; Klinische Forschung
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau
Halle (Saale) , 06120, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Lungenfachklinik Immenhausen
Immenhausen , 34376, Germany
Azienda Ospedaliera San Giuseppe Moscati
Avellino Campania, 83100, Italy
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna Emilia-Romagna, 40138, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Roma Lazio, 00168, Italy
IRCCS AOU San Martino - IST
Genova Liguria, 16132, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Milano Lombardia, 20141, Italy
Asst Di Monza
Monza Lombardia, 20900, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
Pusan National University Hospital
Busan , 602-7, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
ONCARE Viaducto Napoles
Ciudad de México Mexico CITY (federal District), 03810, Mexico
AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V
Ciudad de México Mexico CITY (federal District), 07300, Mexico
Instituto Nacional de Cancerologia; Oncology
Mexico City , 14080, Mexico
Oncológico Potosino
San Luis Potosí , 78209, Mexico
Institut Catala d Oncologia Hospitalet
Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Son Llatzer
Palma de Mallorca Islas Baleares, 07198, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga , 29011, Spain
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Ankara City Hospital; Oncology
Ankara , 06800, Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne , 22030, Turkey
Medipol University Medical Faculty; Oncology Department
Istanbul , 34214, Turkey
?zmir Medical Park; Onkoloji
Izmir , , Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT05775289

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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