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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05775289
Other study ID # BO44178
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 15, 2023
Est. completion date March 30, 2028

Study information

Verified date May 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: BO44178 https://forpatients.roche.com
Phone 888-662-6728
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date March 30, 2028
Est. primary completion date March 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Tobemstomig
Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
Pembrolizumab
Participants will receive IV pembrolizumab four 21-day cycles
Paclitaxel
Participants will receive IV paclitaxel Q3W for four 21-day cycles
Pemetrexed
Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
Carboplatin
Participants will receive IV carboplatin Q3W for four 21-day cycles

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Mexico,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to 58 months)
Primary Objective response rate (ORR) Two consecutive occasions at least 4 weeks apart after a complete response (CR) or partial response (PR) (up to 58 months)
Secondary Overall survival (OS) From randomization to death from any cause (up to 58 months)
Secondary Duration of response (DOR) From the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (up to 58 months)
Secondary PFS in participants with PD-L1 expression Up to 58 months
Secondary OS for participants with PD-L1 expression Up to 58 months
Secondary Change in participant-reported outcomes as assessed by the use of the European Organisation for Research and Treatment (EORTC) item libraries Baseline to week 12
Secondary Percentage of participants with adverse events (AEs) Up to 58 months
Secondary Maximum serum concentration (Cmax) of Tobemstomig Up to 58 months
Secondary Time of maximum concentration (Tmax) of Tobemstomig Up to 58 months
Secondary Clearance (CL) of Tobemstomig Up to 58 months
Secondary Volume of distribution at steady state (Vss) of Tobemstomig Up to 58 months
Secondary Area under the concentration-time curve (AUC) of Tobemstomig Up to 58 months
Secondary Half-life (T1/2) of Tobemstomig Up to 58 months
Secondary Plasma concentration of Carboplatin Up to 58 weeks
Secondary Plasma concentration of pemetrexed Up to 58 months
Secondary Plasma concentration of paclitaxel Up to 58 months
Secondary Percentage of participants with anti-drug antibodies (ADAs) Baseline up to 58 months
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