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.
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
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There are 57 Locations for this study
Detroit Michigan, 48202, United States
Reno Nevada, 89502, United States
Camden New Jersey, 08103, United States
Sioux Falls South Dakota, 57105, United States
Richmond Virginia, 23298, United States
Westmead New South Wales, 2145, Australia
Adelaide South Australia, 5112, Australia
Clayton Victoria, 3168, Australia
Geelong Victoria, 3220, Australia
Brussel , 1090, Belgium
Hasselt , 3500, Belgium
Leuven , 3000, Belgium
Mechelen , 2800, Belgium
Salvador, Bahia BA, 40170, Brazil
Fortaleza CE, 60336, Brazil
Porto Alegre RS, 90040, Brazil
Porto Alegre RS, , Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1Y 4, Canada
Windsor Ontario, N8W 1, Canada
Besancon , 25030, France
Lyon , 69008, France
Paris , 75014, France
Saint Herblain , 44805, France
Strasbourg , 67065, France
Toulouse cedex 9 , 31100, France
Essen , 45122, Germany
Großhansdorf , 22927, Germany
Halle (Saale) , 06120, Germany
Heidelberg , 69126, Germany
Immenhausen , 34376, Germany
Avellino Campania, 83100, Italy
Bologna Emilia-Romagna, 40138, Italy
Roma Lazio, 00168, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20141, Italy
Monza Lombardia, 20900, Italy
Padova Veneto, 35128, Italy
Busan , 602-7, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 08308, Korea, Republic of
Ciudad de México Mexico CITY (federal District), 03810, Mexico
Ciudad de México Mexico CITY (federal District), 07300, Mexico
Mexico City , 14080, Mexico
San Luis Potosí , 78209, Mexico
Hospitalet de Llobregat Barcelona, 08908, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
A Coruña LA Coruña, 15006, Spain
Barcelona , 08035, Spain
Madrid , 28041, Spain
Malaga , 29011, Spain
Ankara , 06520, Turkey
Ankara , 06800, Turkey
Edirne , 22030, Turkey
Istanbul , 34214, Turkey
Izmir , , Turkey
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