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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05775289




Registration number
NCT05775289
Ethics application status
Date submitted
6/03/2023
Date registered
20/03/2023

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
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
Secondary ID [1] 0 0
BO44178
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to 58 months)
Primary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Two consecutive occasions at least 4 weeks apart after a complete response (CR) or partial response (PR) (up to 58 months)
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
From randomization to death from any cause (up to 58 months)
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
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 outcome [3] 0 0
PFS in participants with PD-L1 expression
Timepoint [3] 0 0
Up to 58 months
Secondary outcome [4] 0 0
OS for participants with PD-L1 expression
Timepoint [4] 0 0
Up to 58 months
Secondary outcome [5] 0 0
Change in participant-reported outcomes as assessed by the use of the European Organisation for Research and Treatment (EORTC) item libraries
Timepoint [5] 0 0
Baseline to week 12
Secondary outcome [6] 0 0
Percentage of participants with adverse events (AEs)
Timepoint [6] 0 0
Up to 58 months
Secondary outcome [7] 0 0
Maximum serum concentration (Cmax) of Tobemstomig
Timepoint [7] 0 0
Up to 58 months
Secondary outcome [8] 0 0
Time of maximum concentration (Tmax) of Tobemstomig
Timepoint [8] 0 0
Up to 58 months
Secondary outcome [9] 0 0
Clearance (CL) of Tobemstomig
Timepoint [9] 0 0
Up to 58 months
Secondary outcome [10] 0 0
Volume of distribution at steady state (Vss) of Tobemstomig
Timepoint [10] 0 0
Up to 58 months
Secondary outcome [11] 0 0
Area under the concentration-time curve (AUC) of Tobemstomig
Timepoint [11] 0 0
Up to 58 months
Secondary outcome [12] 0 0
Half-life (T1/2) of Tobemstomig
Timepoint [12] 0 0
Up to 58 months
Secondary outcome [13] 0 0
Plasma concentration of Carboplatin
Timepoint [13] 0 0
Up to 58 weeks
Secondary outcome [14] 0 0
Plasma concentration of pemetrexed
Timepoint [14] 0 0
Up to 58 months
Secondary outcome [15] 0 0
Plasma concentration of paclitaxel
Timepoint [15] 0 0
Up to 58 months
Secondary outcome [16] 0 0
Percentage of participants with anti-drug antibodies (ADAs)
Timepoint [16] 0 0
Baseline up to 58 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2028
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5112 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussel
Country [5] 0 0
Belgium
State/province [5] 0 0
Hasselt
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Mechelen
Country [8] 0 0
Brazil
State/province [8] 0 0
BA
Country [9] 0 0
Brazil
State/province [9] 0 0
CE
Country [10] 0 0
Brazil
State/province [10] 0 0
RS
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Saint Herblain
Country [15] 0 0
France
State/province [15] 0 0
Strasbourg
Country [16] 0 0
France
State/province [16] 0 0
Toulouse cedex 9
Country [17] 0 0
Germany
State/province [17] 0 0
Essen
Country [18] 0 0
Germany
State/province [18] 0 0
Großhansdorf
Country [19] 0 0
Germany
State/province [19] 0 0
Halle (Saale)
Country [20] 0 0
Germany
State/province [20] 0 0
Heidelberg
Country [21] 0 0
Germany
State/province [21] 0 0
Immenhausen
Country [22] 0 0
Italy
State/province [22] 0 0
Campania
Country [23] 0 0
Italy
State/province [23] 0 0
Emilia-Romagna
Country [24] 0 0
Italy
State/province [24] 0 0
Lazio
Country [25] 0 0
Italy
State/province [25] 0 0
Liguria
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardia
Country [27] 0 0
Italy
State/province [27] 0 0
Veneto
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Busan
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Mexico
State/province [30] 0 0
Mexico CITY (federal District)
Country [31] 0 0
Mexico
State/province [31] 0 0
Mexico City
Country [32] 0 0
Mexico
State/province [32] 0 0
San Luis Potosí
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Islas Baleares
Country [35] 0 0
Spain
State/province [35] 0 0
LA Coruña
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Malaga
Country [38] 0 0
Turkey
State/province [38] 0 0
Ankara
Country [39] 0 0
Turkey
State/province [39] 0 0
Edirne
Country [40] 0 0
Turkey
State/province [40] 0 0
Istanbul
Country [41] 0 0
Turkey
State/province [41] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-LaRoche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO44178 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05775289