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

NCT05775289 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: BO44178
• Study Type: interventional
• Target: 182
• Locations: 11 countries
• Sites: 50

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 15 months

Secondary Outcomes (24)

• Overall Survival (OS)

  From randomization to death from any cause (up to approximately 15 months)

• Duration of Response (DOR)

  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

  Up to 28 months

• OS for Participants With PD-L1 Expression

  Up to 28 months

• Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning

  Baseline to week 12

Study Arms (2)

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.

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.

Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin

Interventions

Tobemstomig DRUG

Participants will receive intravenous (IV) tobemstomig for four 21-day cycles

Also known as: RO7247669

Arm A: Tobemstomig + Platinum-Based Chemotherapy

Pembrolizumab DRUG

Participants will receive IV pembrolizumab four 21-day cycles

Arm B: Pembrolizumab + Platinum-Based Chemotherapy

Paclitaxel DRUG

Participants will receive IV paclitaxel Q3W for four 21-day cycles

Arm A: Tobemstomig + Platinum-Based Chemotherapy; Arm B: Pembrolizumab + Platinum-Based Chemotherapy

Pemetrexed DRUG

Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity

Arm A: Tobemstomig + Platinum-Based Chemotherapy; Arm B: Pembrolizumab + Platinum-Based Chemotherapy

Carboplatin DRUG

Participants will receive IV carboplatin Q3W for four 21-day cycles

Arm A: Tobemstomig + Platinum-Based Chemotherapy; Arm B: Pembrolizumab + Platinum-Based Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (50)

Henry Ford Health System

Detroit, Michigan, 48202-2689, United States

Location

Renown Regional Medical Center Hospital

Reno, Nevada, 89502-1576, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Lyell McEwin Hospital

Adelaide, South Australia, 5112, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Monash Health

Melbourne, Victoria, 3168, Australia

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

AZ St Maarten Campus Leopoldstr

Mechelen, 2800, Belgium

Location

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-550, Brazil

Location

Nucleo de Oncologia da Bahia - NOB

Salvador, Bahia, Estado de Bahia, 40170-380, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hopital Cochin

Paris, 75679, France

Location

Ico Rene Gauducheau

Saint-Herblain, 44805, France

Location

CHU de Toulouse - Hôpital Larrey

Toulouse, 31100, France

Location

Uniklinik Essen

Essen, 45122, Germany

Location

LungenClinic Großhansdorf GmbH

Großhansdorf, 22927, Germany

Location

Krankenhaus Martha-Maria Halle-Doelau

Halle, 06120, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Campania, 83100, Italy

Location

AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

Bologna, Emilia-Romagna, 40138, Italy

Location

Policlinico Universitario "Agostino Gemelli"

Rome, Lazio, 00168, Italy

Location

IRCCS AOU San Martino - IST

Genoa, Liguria, 16132, Italy

Location

Irccs Istituto Europeo di Oncologia (IEO)

Milan, Lombardy, 20141, Italy

Location

Asst Di Monza

Monza, Lombardy, 20900, Italy

Location

IOV - Istituto Oncologico Veneto - IRCCS

Padua, Veneto, 35128, Italy

Location

ONCARE Viaducto Napoles

Mexico City, Mexico CITY (federal District), 03810, Mexico

Location

AMIISTO Atencion Medica Integral Investigacion y Terapia Oncologica S.A de C.V

Mexico City, Mexico CITY (federal District), 07300, Mexico

Location

Instituto Nacional de Cancerologia

Distrito Federal, 14080, Mexico

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Institut Catala d Oncologia Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, 15006, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29011, Spain

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, 22030, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

?zmir Medical Park

Izm?r, 35575, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Paclitaxel; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-LaRoche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 20, 2023
• Study Start: March 15, 2023
• Primary Completion: June 20, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 11, 2026
• Results First Posted: November 19, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (4); US (2); DE (5); ME (3); KR (4); TU (5); BR (6); BE (4); AU (4); IT (7); ES (6)