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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05775289
Recruitment Status : Recruiting
First Posted : March 20, 2023
Last Update Posted : May 30, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Tobemstomig Drug: Pembrolizumab Drug: Paclitaxel Drug: Pemetrexed Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : March 30, 2026
Estimated Study Completion Date : March 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.

Drug: Tobemstomig
Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
Other Name: RO7247669

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

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

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

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.

Drug: Pembrolizumab
Participants will receive IV pembrolizumab four 21-day cycles

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

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

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




Primary Outcome Measures :
  1. 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) ]
  2. 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 Measures :
  1. Overall survival (OS) [ Time Frame: From randomization to death from any cause (up to 58 months) ]
  2. 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) ]
  3. PFS in participants with PD-L1 expression [ Time Frame: Up to 58 months ]
  4. OS for participants with PD-L1 expression [ Time Frame: Up to 58 months ]
  5. 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 ]
  6. Percentage of participants with adverse events (AEs) [ Time Frame: Up to 58 months ]
  7. Maximum serum concentration (Cmax) of Tobemstomig [ Time Frame: Up to 58 months ]
  8. Time of maximum concentration (Tmax) of Tobemstomig [ Time Frame: Up to 58 months ]
  9. Clearance (CL) of Tobemstomig [ Time Frame: Up to 58 months ]
  10. Volume of distribution at steady state (Vss) of Tobemstomig [ Time Frame: Up to 58 months ]
  11. Area under the concentration-time curve (AUC) of Tobemstomig [ Time Frame: Up to 58 months ]
  12. Half-life (T1/2) of Tobemstomig [ Time Frame: Up to 58 months ]
  13. Plasma concentration of Carboplatin [ Time Frame: Up to 58 weeks ]
  14. Plasma concentration of pemetrexed [ Time Frame: Up to 58 months ]
  15. Plasma concentration of paclitaxel [ Time Frame: Up to 58 months ]
  16. Percentage of participants with anti-drug antibodies (ADAs) [ Time Frame: Baseline up to 58 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05775289


Contacts
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Contact: Reference Study ID Number: BO44178 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-LaRoche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05775289    
Other Study ID Numbers: BO44178
First Posted: March 20, 2023    Key Record Dates
Last Update Posted: May 30, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors