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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05775289
Registration number
NCT05775289
Ethics application status
Date submitted
6/03/2023
Date registered
20/03/2023
Date last updated
30/05/2024
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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BO44178
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tobemstomig
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Experimental: Arm A: Tobemstomig + Platinum-Based Chemotherapy - 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.
Active Comparator: Arm B: Pembrolizumab + Platinum-Based Chemotherapy - 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.
Treatment: Drugs: Tobemstomig
Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
Treatment: Drugs: Pembrolizumab
Participants will receive IV pembrolizumab four 21-day cycles
Treatment: Drugs: Paclitaxel
Participants will receive IV paclitaxel Q3W for four 21-day cycles
Treatment: Drugs: Pemetrexed
Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
Treatment: Drugs: Carboplatin
Participants will receive IV carboplatin Q3W for four 21-day cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS)
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Assessment method [1]
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Timepoint [1]
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From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to 58 months)
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Primary outcome [2]
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Objective response rate (ORR)
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Assessment method [2]
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Timepoint [2]
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Two consecutive occasions at least 4 weeks apart after a complete response (CR) or partial response (PR) (up to 58 months)
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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Timepoint [1]
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From randomization to death from any cause (up to 58 months)
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Secondary outcome [2]
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Duration of response (DOR)
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Assessment method [2]
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Timepoint [2]
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From the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (up to 58 months)
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Secondary outcome [3]
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PFS in participants with PD-L1 expression
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Assessment method [3]
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Timepoint [3]
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Up to 58 months
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Secondary outcome [4]
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OS for participants with PD-L1 expression
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Assessment method [4]
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Timepoint [4]
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Up to 58 months
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Secondary outcome [5]
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Change in participant-reported outcomes as assessed by the use of the European Organisation for Research and Treatment (EORTC) item libraries
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Assessment method [5]
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Timepoint [5]
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Baseline to week 12
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Secondary outcome [6]
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Percentage of participants with adverse events (AEs)
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Assessment method [6]
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Timepoint [6]
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Up to 58 months
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Secondary outcome [7]
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Maximum serum concentration (Cmax) of Tobemstomig
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Assessment method [7]
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Timepoint [7]
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Up to 58 months
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Secondary outcome [8]
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Time of maximum concentration (Tmax) of Tobemstomig
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Assessment method [8]
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Timepoint [8]
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Up to 58 months
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Secondary outcome [9]
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Clearance (CL) of Tobemstomig
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Assessment method [9]
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Timepoint [9]
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Up to 58 months
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Secondary outcome [10]
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Volume of distribution at steady state (Vss) of Tobemstomig
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Assessment method [10]
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Timepoint [10]
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Up to 58 months
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Secondary outcome [11]
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Area under the concentration-time curve (AUC) of Tobemstomig
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Assessment method [11]
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Timepoint [11]
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Up to 58 months
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Secondary outcome [12]
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Half-life (T1/2) of Tobemstomig
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Assessment method [12]
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Timepoint [12]
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Up to 58 months
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Secondary outcome [13]
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Plasma concentration of Carboplatin
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Assessment method [13]
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Timepoint [13]
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Up to 58 weeks
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Secondary outcome [14]
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Plasma concentration of pemetrexed
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Assessment method [14]
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Timepoint [14]
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Up to 58 months
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Secondary outcome [15]
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Plasma concentration of paclitaxel
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Assessment method [15]
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Timepoint [15]
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Up to 58 months
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Secondary outcome [16]
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Percentage of participants with anti-drug antibodies (ADAs)
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Assessment method [16]
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Timepoint [16]
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Baseline up to 58 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/03/2028
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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Pindara Private Hospital - Benowa
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Recruitment hospital [3]
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Lyell McEwin Hospital - Adelaide
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Recruitment hospital [4]
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Monash Health - Clayton
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Recruitment hospital [5]
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Barwon Health - Geelong
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment postcode(s) [3]
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5112 - Adelaide
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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State/province [3]
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Nevada
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Country [4]
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United States of America
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State/province [4]
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New Jersey
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Country [5]
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United States of America
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State/province [5]
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South Dakota
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Country [6]
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United States of America
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Virginia
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Country [7]
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Belgium
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Brussel
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Belgium
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Charleroi
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Belgium
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State/province [9]
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Hasselt
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Belgium
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Leuven
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Belgium
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Mechelen
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Country [12]
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Brazil
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State/province [12]
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BA
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Country [13]
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Brazil
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CE
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Country [14]
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Brazil
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State/province [14]
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RS
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Country [15]
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Brazil
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State/province [15]
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SP
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Country [16]
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Canada
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State/province [16]
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Ontario
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France
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Besancon
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France
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Lyon
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France
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Paris
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France
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Saint Herblain
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France
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Strasbourg
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France
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Toulouse cedex 9
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Germany
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Essen
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Germany
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Großhansdorf
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Germany
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Halle (Saale)
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Germany
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Heidelberg
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Germany
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Immenhausen
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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State/province [30]
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Lazio
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Italy
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State/province [31]
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Liguria
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Italy
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Lombardia
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Italy
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Veneto
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Korea, Republic of
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Busan
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Korea, Republic of
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Seoul
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Mexico
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Mexico CITY (federal District)
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Mexico
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Mexico City
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Mexico
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San Luis Potosí
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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LA Coruña
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Spain
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Madrid
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Spain
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Malaga
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05775289
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-LaRoche
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: BO44178 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05775289
Download to PDF