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A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tobemstomig
Pembrolizumab
Paclitaxel
Pemetrexed
Carboplatin
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mitchell Cancer Institute; PharmacyRecruiting
  • Renown Regional Medical Center HospitalRecruiting
  • Avera Cancer InstituteRecruiting
  • Virginia Commonwealth University Medical Center Main HospitalRecruiting
  • Westmead Hospital
  • Pindara Private Hospital
  • Lyell McEwin Hospital
  • Monash Health
  • Barwon HealthRecruiting
  • UZ BrusselRecruiting
  • GHdC Site Notre DameRecruiting
  • Jessa Zkh (Campus Virga Jesse)Recruiting
  • UZ Leuven GasthuisbergRecruiting
  • AZ St Maarten Campus LeopoldstrRecruiting
  • Nucleo de Oncologia da Bahia - NOBRecruiting
  • Crio - Centro Regional Integrado de OncologiaRecruiting
  • Hospital Nossa Senhora da ConceicaoRecruiting
  • Hospital de Cancer de BarretosRecruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • Lakeridge Health OshawaRecruiting
  • Ottawa Hospital Research InstituteRecruiting
  • Windsor Regional HospitalRecruiting
  • Hopital Cochin; Unite Fonctionnelle D OncologieRecruiting
  • Ico Rene Gauducheau; OncologieRecruiting
  • Uniklinik EssenRecruiting
  • LungenClinic Großhansdorf GmbHRecruiting
  • Krankenhaus Martha-Maria Halle-DoelauRecruiting
  • Thoraxklinik Heidelberg gGmbHRecruiting
  • Lungenfachklinik ImmenhausenRecruiting
  • Azienda Ospedaliera San Giuseppe MoscatiRecruiting
  • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia MedicaRecruiting
  • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
  • IRCCS AOU San Martino - ISTRecruiting
  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di OncologiaRecruiting
  • Asst Di MonzaRecruiting
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica IIRecruiting
  • Pusan National University Hospital
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Korea University Guro HospitalRecruiting
  • Institut Catala d Oncologia HospitaletRecruiting
  • Hospital Son LlatzerRecruiting
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de OncologiaRecruiting
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
  • Hospital Regional Universitario Carlos Haya; Servicio de OncologiaRecruiting
  • Memorial Ankara Hastanesi
  • Ankara City Hospital; Oncology
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan YerleskesiRecruiting
  • Medipol University Medical Faculty; Oncology DepartmentRecruiting
  • ?zmir Medical Park; Onkoloji

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Tobemstomig + Platinum-Based Chemotherapy

Arm B: Pembrolizumab + Platinum-Based Chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Objective response rate (ORR)

Secondary Outcome Measures

Overall survival (OS)
Duration of response (DOR)
PFS in participants with PD-L1 expression
OS for participants with PD-L1 expression
Change in participant-reported outcomes as assessed by the use of the European Organisation for Research and Treatment (EORTC) item libraries
Percentage of participants with adverse events (AEs)
Maximum serum concentration (Cmax) of Tobemstomig
Time of maximum concentration (Tmax) of Tobemstomig
Clearance (CL) of Tobemstomig
Volume of distribution at steady state (Vss) of Tobemstomig
Area under the concentration-time curve (AUC) of Tobemstomig
Half-life (T1/2) of Tobemstomig
Plasma concentration of Carboplatin
Plasma concentration of pemetrexed
Plasma concentration of paclitaxel
Percentage of participants with anti-drug antibodies (ADAs)

Full Information

First Posted
March 6, 2023
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05775289
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 30, 2026 (Anticipated)
Study Completion Date
March 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Tobemstomig + Platinum-Based Chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B: Pembrolizumab + Platinum-Based Chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tobemstomig
Other Intervention Name(s)
RO7247669
Intervention Description
Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Participants will receive IV pembrolizumab four 21-day cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Participants will receive IV paclitaxel Q3W for four 21-day cycles
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Participants will receive IV carboplatin Q3W for four 21-day cycles
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to 58 months)
Title
Objective response rate (ORR)
Time Frame
Two consecutive occasions at least 4 weeks apart after a complete response (CR) or partial response (PR) (up to 58 months)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
From randomization to death from any cause (up to 58 months)
Title
Duration of response (DOR)
Time Frame
From the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (up to 58 months)
Title
PFS in participants with PD-L1 expression
Time Frame
Up to 58 months
Title
OS for participants with PD-L1 expression
Time Frame
Up to 58 months
Title
Change in participant-reported outcomes as assessed by the use of the European Organisation for Research and Treatment (EORTC) item libraries
Time Frame
Baseline to week 12
Title
Percentage of participants with adverse events (AEs)
Time Frame
Up to 58 months
Title
Maximum serum concentration (Cmax) of Tobemstomig
Time Frame
Up to 58 months
Title
Time of maximum concentration (Tmax) of Tobemstomig
Time Frame
Up to 58 months
Title
Clearance (CL) of Tobemstomig
Time Frame
Up to 58 months
Title
Volume of distribution at steady state (Vss) of Tobemstomig
Time Frame
Up to 58 months
Title
Area under the concentration-time curve (AUC) of Tobemstomig
Time Frame
Up to 58 months
Title
Half-life (T1/2) of Tobemstomig
Time Frame
Up to 58 months
Title
Plasma concentration of Carboplatin
Time Frame
Up to 58 weeks
Title
Plasma concentration of pemetrexed
Time Frame
Up to 58 months
Title
Plasma concentration of paclitaxel
Time Frame
Up to 58 months
Title
Percentage of participants with anti-drug antibodies (ADAs)
Time Frame
Baseline up to 58 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO44178 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-LaRoche
Official's Role
Study Director
Facility Information:
Facility Name
Mitchell Cancer Institute; Pharmacy
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Name
Renown Regional Medical Center Hospital
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502-1576
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University Medical Center Main Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Lyell McEwin Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ St Maarten Campus Leopoldstr
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Nucleo de Oncologia da Bahia - NOB
City
Salvador, Bahia
State/Province
BA
ZIP/Postal Code
40170-380
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Crio - Centro Regional Integrado de Oncologia
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Windsor Regional Hospital
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1L9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Cochin; Unite Fonctionnelle D Oncologie
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Uniklinik Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Martha-Maria Halle-Doelau
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Giuseppe Moscati
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Recruiting
Facility Name
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS AOU San Martino - IST
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asst Di Monza
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Hospitalet
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
?zmir Medical Park; Onkoloji
City
Izmir
Country
Turkey
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).

Learn more about this trial

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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