Trial Title:
A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
NCT ID:
NCT05775289
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Tobemstomig
Description:
Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
Arm group label:
Arm A: Tobemstomig + Platinum-Based Chemotherapy
Other name:
RO7247669
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Participants will receive IV pembrolizumab four 21-day cycles
Arm group label:
Arm B: Pembrolizumab + Platinum-Based Chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Participants will receive IV paclitaxel Q3W for four 21-day cycles
Arm group label:
Arm A: Tobemstomig + Platinum-Based Chemotherapy
Arm group label:
Arm B: Pembrolizumab + Platinum-Based Chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Participants will receive IV pemetrexed Q3W until disease progression or unacceptable
toxicity
Arm group label:
Arm A: Tobemstomig + Platinum-Based Chemotherapy
Arm group label:
Arm B: Pembrolizumab + Platinum-Based Chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Participants will receive IV carboplatin Q3W for four 21-day cycles
Arm group label:
Arm A: Tobemstomig + Platinum-Based Chemotherapy
Arm group label:
Arm B: Pembrolizumab + Platinum-Based Chemotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henry Ford Health System; Hematology/Oncology
Address:
City:
Detroit
Zip:
48202-2689
Country:
United States
Facility:
Name:
Renown Regional Medical Center Hospital
Address:
City:
Reno
Zip:
89502-1576
Country:
United States
Facility:
Name:
Virginia Commonwealth University Medical Center Main Hospital
Address:
City:
Richmond
Zip:
23298
Country:
United States
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Facility:
Name:
Lyell McEwin Hospital
Address:
City:
Adelaide
Zip:
5112
Country:
Australia
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Facility:
Name:
Barwon Health
Address:
City:
Geelong
Zip:
3220
Country:
Australia
Facility:
Name:
UZ Brussel
Address:
City:
Brussel
Zip:
1090
Country:
Belgium
Facility:
Name:
Jessa Zkh (Campus Virga Jesse)
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Facility:
Name:
UZ Leuven Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
AZ St Maarten Campus Leopoldstr
Address:
City:
Mechelen
Zip:
2800
Country:
Belgium
Facility:
Name:
Nucleo de Oncologia da Bahia - NOB
Address:
City:
Salvador, Bahia
Zip:
40170-380
Country:
Brazil
Facility:
Name:
Crio - Centro Regional Integrado de Oncologia
Address:
City:
Fortaleza
Zip:
60336-232
Country:
Brazil
Facility:
Name:
Hospital Nossa Senhora da Conceicao
Address:
City:
Porto Alegre
Zip:
90040-373
Country:
Brazil
Facility:
Name:
Hospital de Clínicas de Porto Alegre X
Address:
City:
Porto Alegre
Country:
Brazil
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo - ICESP
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
Hopital Cochin; Unite Fonctionnelle D Oncologie
Address:
City:
Paris
Zip:
75014
Country:
France
Facility:
Name:
Ico Rene Gauducheau; Oncologie
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Facility:
Name:
Centre Paul Strauss; Oncologie Medicale
Address:
City:
Strasbourg
Zip:
67065
Country:
France
Facility:
Name:
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Address:
City:
Toulouse cedex 9
Zip:
31100
Country:
France
Facility:
Name:
Uniklinik Essen
Address:
City:
Essen
Zip:
45122
Country:
Germany
Facility:
Name:
LungenClinic Großhansdorf GmbH; Klinische Forschung
Address:
City:
Großhansdorf
Zip:
22927
Country:
Germany
Facility:
Name:
Krankenhaus Martha-Maria Halle-Doelau
Address:
City:
Halle (Saale)
Zip:
06120
Country:
Germany
Facility:
Name:
Thoraxklinik Heidelberg gGmbH
Address:
City:
Heidelberg
Zip:
69126
Country:
Germany
Facility:
Name:
Lungenfachklinik Immenhausen
Address:
City:
Immenhausen
Zip:
34376
Country:
Germany
Facility:
Name:
Azienda Ospedaliera San Giuseppe Moscati
Address:
City:
Avellino
Zip:
83100
Country:
Italy
Facility:
Name:
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Facility:
Name:
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Address:
City:
Roma
Zip:
00168
Country:
Italy
Facility:
Name:
IRCCS AOU San Martino - IST
Address:
City:
Genova
Zip:
16132
Country:
Italy
Facility:
Name:
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Facility:
Name:
Asst Di Monza
Address:
City:
Monza
Zip:
20900
Country:
Italy
Facility:
Name:
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
Pusan National University Hospital
Address:
City:
Busan
Zip:
602-739
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Facility:
Name:
ONCARE Viaducto Napoles
Address:
City:
Ciudad de México
Zip:
03810
Country:
Mexico
Facility:
Name:
AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V
Address:
City:
Ciudad de México
Zip:
07300
Country:
Mexico
Facility:
Name:
Instituto Nacional de Cancerologia; Oncology
Address:
City:
Mexico City
Zip:
14080
Country:
Mexico
Facility:
Name:
Oncológico Potosino
Address:
City:
San Luis Potosí
Zip:
78209
Country:
Mexico
Facility:
Name:
Institut Catala d Oncologia Hospitalet
Address:
City:
Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Facility:
Name:
Hospital Son Llatzer
Address:
City:
Palma de Mallorca
Zip:
07198
Country:
Spain
Facility:
Name:
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Facility:
Name:
Hospital Universitari Vall d'Hebron; Oncology
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Address:
City:
Malaga
Zip:
29011
Country:
Spain
Facility:
Name:
Memorial Ankara Hastanesi
Address:
City:
Ankara
Zip:
06520
Country:
Turkey
Facility:
Name:
Ankara City Hospital; Oncology
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Facility:
Name:
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Facility:
Name:
Medipol University Medical Faculty; Oncology Department
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Facility:
Name:
?zmir Medical Park; Onkoloji
Address:
City:
Izmir
Country:
Turkey
Start date:
March 15, 2023
Completion date:
March 30, 2028
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775289
