Non-small Cell Lung CancerPhase 2NCT05775289
A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
A Phase 2 study testing Tobemstomig, Pembrolizumab and Paclitaxel in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 50 sites in 11 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Tobemstomig, Pembrolizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 50 sitesin 11 countries
- Study dates
- 15 Mar 2023to 30 Apr 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
50 sites in 11 countries.
50 sites in 11 countries
Italy7 sites
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, 83100
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, 40138
IRCCS AOU San Martino - IST
Genoa, Liguria, 16132
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, 20141
Asst Di Monza
Monza, Lombardy, 20900
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
Policlinico Universitario "Agostino Gemelli"
Rome, Lazio, 00168
Brazil6 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-550
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia, Estado de Bahia, 40170-380
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Spain6 sites
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, 15006
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Institut Catala d Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario Carlos Haya
Málaga, 29011
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Germany5 sites
Uniklinik Essen
Essen, 45122
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927
Krankenhaus Martha-Maria Halle-Doelau
Halle, 06120
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126
Lungenfachklinik Immenhausen
Immenhausen, 34376
Turkey (Türkiye)5 sites
Memorial Ankara Hastanesi
Ankara, 06520
Ankara City Hospital
Ankara, 06800
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030
Medipol University Medical Faculty
Istanbul, 34214
?zmir Medical Park
Izm?r, 35575
Australia4 sites
Lyell McEwin Hospital
Adelaide, South Australia, 5112
Barwon Health
Geelong, Victoria, 3220
Monash Health
Melbourne, Victoria, 3168
Westmead Hospital
Westmead, New South Wales, 2145
Belgium4 sites
UZ Brussel
Brussels, 1090
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
UZ Leuven Gasthuisberg
Leuven, 3000
AZ St Maarten Campus Leopoldstr
Mechelen, 2800
France4 sites
Centre Leon Berard
Lyon, 69008
Hopital Cochin
Paris, 75679
Ico Rene Gauducheau
Saint-Herblain, 44805
CHU de Toulouse - Hôpital Larrey
Toulouse, 31100
South Korea4 sites
Pusan National University Hospital
Busan, 49241
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Korea University Guro Hospital
Seoul, 08308
Mexico3 sites
Instituto Nacional de Cancerologia
Distrito Federal, 14080
ONCARE Viaducto Napoles
Mexico City, Mexico CITY (federal District), 03810
AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V
Mexico City, Mexico CITY (federal District), 07300
United States2 sites
Henry Ford Health System
Detroit, Michigan, 48202-2689
Renown Regional Medical Center Hospital
Reno, Nevada, 89502-1576
About this study
Official title: A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of Tobemstomig Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Tobemstomig, Pembrolizumab, Paclitaxel, Pemetrexed, Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobemstomigDrug
Also called RO7247669
Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
PembrolizumabDrug
Participants will receive IV pembrolizumab four 21-day cycles
PaclitaxelDrug
Participants will receive IV paclitaxel Q3W for four 21-day cycles
PemetrexedDrug
Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
CarboplatinDrug
Participants will receive IV carboplatin Q3W for four 21-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Tobemstomig + Platinum-Based Chemotherapy | Experimental | Participants with non-squamous (NSQ) NSCLC will receive induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks (Q3W) for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig together with pemetrexed until disease progression or treatment discontinuation.
Participants with squamous (SQ) NSCLC will receive blinded tobemstomig in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21 day cycles, followed by blinded tobemstomig (on Day 1) Q3W until disease progression or treatment discontinuation. Receives: Drug: Tobemstomig; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin |
| Arm B: Pembrolizumab + Platinum-Based Chemotherapy | Active comparator | Participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by a maintenance therapy with blinded pembrolizumab together with pemetrexed Q3W until disease progression or treatment discontinuation.
Participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) Q3W until disease progression or treatment discontinuation. Receives: Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Randomization to date of first documented disease progression or death (up to approximately 15 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who experience a complete reponse or partial response on two consecutive occasions at least 4 weeks apart as determined by the investigator according to RECIST v1.1.
Measured: Up to approximately 15 months
Secondary outcomes (24)
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: From randomization to death from any cause (up to approximately 15 months)
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.
Measured: From the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (up to approximately 15 months)
PFS in Participants With PD-L1 Expression
Measured: Up to 28 months
OS for Participants With PD-L1 Expression
Measured: Up to 28 months
Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning
The EORTC Item Library 17 (IL17) physical functioning scale measures a participant's ability to perform a variety of physical activities. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate better outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL)
The EORTC Item Library 17 (IL17) Global Health Status/Quality of Life (GHS/QoL) scale measures the participant's overall health and quality of health over the last week. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate a higher quality of life.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning
The EORTC Item Library 17 (IL17) role functioning scale measures the degree to which disease or treatment interferes with the participant's work or daily activities. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate better outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough
The EORTC IL 85 lung cancer symptoms/how much did you cough measure assesses the severity and frequency of coughing over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested
The EORTC IL 85 short of breath when rested measure assesses the degree of difficulty breathing while resting over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked
The EORTC IL 85 short of breath when walked measure assesses the degree of difficulty breathing while walking over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs
The EORTC IL 85 short of breath climbed stairs measure assesses the degree of difficulty breathing while climbing stairs over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest
The EORTC IL 85 pain in chest measure assesses the severity of chest pain over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest
The EORTC IL 132 need to rest measure assesses how often the participant felt the need to rest over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak
The EORTC IL 132 felt weak measure assesses how often the participant felt weak over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Tired
The EORTC IL 132 tired measure assesses how often the participant felt tired over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones
The EORTC IL 188 aches/pain in bones measure assessesthe severity of bone pain over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.
Measured: Baseline to week 12
Number of Participants With Adverse Events (AEs)
Measured: From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Maximum Serum Concentration (Cmax) of Tobemstomig
Measured: Up to approximately 15 months
Time of Maximum Concentration (Tmax) of Tobemstomig
Measured: Up to approximately 15 months
Clearance (CL) of Tobemstomig
Measured: Up to approximately 15 months
Volume of Distribution at Steady State (Vss) of Tobemstomig
Measured: Up to approximately 15 months
Area Under the Concentration-time Curve (AUC) of Tobemstomig
Measured: Up to approximately 15 months
Half-life (T1/2) of Tobemstomig
Measured: Up to approximately 15 months
Percentage of Participants With Anti-drug Antibodies (ADAs)
Measured: Baseline up to approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Mar 2023
- Primary completion20 Jun 2024
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-LaRoche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775289
- Sponsor's protocol ID
- BO44178
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2023
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing