Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Tobemstomig with Platinum-Based Chemotherapy vs Pembrolizumab with Platinum-Based Chemotherapy for Untreated Non-Small Cell Lung Cancer Patients

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for non-small cell lung cancer (NSCLC), which is a type of lung cancer that has not been treated before and is either locally advanced or has spread to other parts of the body. The study is comparing two different treatment combinations. One group of participants will receive a new medication called Tobemstomig along with standard platinum-based chemotherapy. The other group will receive Pembrolizumab, a medication that helps the immune system fight cancer, also combined with platinum-based chemotherapy. The purpose of the study is to evaluate how effective these treatments are in controlling the cancer and improving patient outcomes.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will be conducted in a way that neither the participants nor the researchers know which treatment each participant is receiving, which is known as a double-blind study. The treatments will be given through an intravenous infusion, which means they are administered directly into the bloodstream. The study will last for a period of time, during which participants will receive regular treatments and be monitored for any changes in their condition.

The study aims to understand how well the treatments work by looking at how long participants live without the cancer getting worse and how many participants experience a reduction in their cancer size. The study will also monitor the safety of the treatments and any side effects that may occur. By comparing the two treatment combinations, researchers hope to find the most effective approach for treating non-small cell lung cancer in patients who have not received prior treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including performance status and tumor characteristics.

    No prior treatment for the specific type of lung cancer is allowed before joining.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving tobemstomig with platinum-based chemotherapy, and the other receiving pembrolizumab with platinum-based chemotherapy.

  3. Step 3

    Treatment administration

    Treatment involves intravenous (IV) infusions of medications.

    The medications include paclitaxel, carboplatin, pembrolizumab, pemetrexed, and RO7247669.

    The specific dosage and frequency of administration are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring of health status and response to treatment is conducted.

    Assessments include measuring progression-free survival and response rates.

    Patient-reported outcomes on symptoms and quality of life are evaluated.

  5. Step 5

    Follow-up

    Follow-up involves continued monitoring for disease progression or any adverse effects.

    The study aims to collect data on overall survival and duration of response.

Who can join the trial?

8 criteria

  • The patient must have **previously untreated** locally advanced or metastatic non-small cell lung cancer (NSCLC). This means the cancer has not been treated before and is either in a nearby area or has spread to other parts of the body.
  • The patient should have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • The cancer must be **histologically or cytologically documented** as locally advanced, unresectable (Stage IIIB/IIIC), or metastatic (Stage IV). This means the cancer has been confirmed through a study of the tissue or cells and is either advanced in the local area, cannot be removed by surgery, or has spread to other parts of the body.
  • The patient should not have had any **prior systemic treatment** for metastatic NSCLC. This means they have not received treatments that affect the entire body, like chemotherapy, for this type of cancer.
  • The patient must have a **known tumor PD-L1 status**. PD-L1 is a protein that can be found on cancer cells, and knowing its status helps in deciding treatment options.
  • There must be **confirmed availability of representative tumor specimens**. This means there should be samples of the tumor available for study.
  • The patient must have **adequate hematologic and end-organ function**. This means their blood and major organs, like the liver and kidneys, are working well enough to handle the treatment.
  • The patient should be within the age range of adults, as both male and female subjects are eligible.

Who cannot join the trial?

10 criteria

  • Patients who have already received treatment for their lung cancer.
  • Patients with other types of lung cancer that are not non-small cell lung cancer (NSCLC).
  • Patients who have serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with allergies to the study medications.
  • Patients with certain infections that could affect the study results.
  • Patients with a history of other cancers, unless they have been in remission for a certain period.
  • Patients with certain heart conditions that could pose a risk during the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Tobemstomig

    is an investigational medication being studied for its potential to treat non-small cell lung cancer. In this trial, it is being tested in combination with platinum-based chemotherapy to see if it can help stop the cancer from growing or spreading.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer, including non-small cell lung cancer. In this trial, it is being combined with platinum-based chemotherapy to evaluate its effectiveness in treating patients with advanced lung cancer.

  • Platinum-Based Chemotherapy

    refers to a group of chemotherapy drugs that contain platinum. These drugs are commonly used to treat various types of cancer, including lung cancer, by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this trial, platinum-based chemotherapy is used in combination with either tobemstomig or pembrolizumab.

What is already known about the treatment

  • Tobemstomig

    Tobemstomig is administered intravenously, typically in combination with platinum-based chemotherapy. It is currently being studied in clinical trials for its effectiveness in treating previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). The medication works by targeting specific pathways involved in cancer cell growth and survival, aiming to inhibit tumor progression. Tobemstomig is classified as an investigational drug, and its use is primarily within the context of clinical research to determine its safety and efficacy.

  • Pembrolizumab

    Pembrolizumab is given as an intravenous infusion, often used alongside platinum-based chemotherapy. It is an established medication in the treatment of various cancers, including non-small cell lung cancer (NSCLC), and is well-documented in medical literature. Pembrolizumab functions by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor and is widely used in oncology for its ability to enhance the body's immune response against tumors.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is known for its slow progression compared to small cell lung cancer. It often spreads to other parts of the body, including the lymph nodes, bones, brain, and liver. The disease is typically diagnosed at an advanced stage, as early symptoms can be mild or mistaken for other conditions. As it progresses, symptoms may include persistent cough, chest pain, and difficulty breathing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505211-21-00Protocol codeBO44178Estimated enrolment180 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.