All studies
Active not recruitingPHASE2INTERVENTIONAL

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

This study is for people with a type of lung cancer called non-small cell lung cancer that has not been treated before. This cancer is either advanced, meaning it has spread beyond where it started but can't be removed by surgery, or it has spread to other parts of the body. The study aims to compare a new medicine called tobemstomig, given alongside standard chemotherapy, with another established treatment called pembrolizumab, also given with chemotherapy. Researchers want to find out if tobemstomig with chemotherapy is a safe and effective new option for this type of lung cancer. The study will look at how well the treatments work and any side effects people might experience.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Enrolment target
182
Start
15 Mar 2023
Estimated completion
01 Jun 2026

Results

Results from this study

Posted November 2025

Results have been published for this study.

Primary outcome
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.
Full results on the registry

What is this study about?

This study is looking into a type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common kind of lung cancer. The patients in this study have cancer that is either advanced (what doctors call Stage IIIB/IIIC), meaning it has grown quite a lot locally and can't be taken out with surgery or treated with certain types of strong radiation, or it has spread to other parts of the body (Stage IV), which is also known as metastatic cancer. Importantly, everyone in this study will not have had any treatment for their advanced lung cancer before.

The main goal of this study is to compare two different treatment approaches. One group of patients will receive a new medicine called tobemstomig, combined with traditional chemotherapy drugs like paclitaxel, pemetrexed, and carboplatin. The other group will receive a widely used treatment called pembrolizumab, also combined with these chemotherapy drugs. Both tobemstomig and pembrolizumab are types of immunotherapy, which work by helping your body's immune system fight cancer cells.

By comparing these two combinations, researchers hope to understand if tobemstomig plus chemotherapy is a better, safer, or equally effective treatment option for people with previously untreated advanced non-small cell lung cancer. They will be carefully watching to see how well the treatments shrink the cancer, how long they keep the cancer from growing, and what side effects people might have. This information will help doctors decide on the best treatments in the future.

Key takeaways

  • New study comparing two treatments for advanced non-small cell lung cancer.
  • Patients involved have not had prior treatment for their advanced cancer.
  • Looks at a new drug (tobemstomig) with chemotherapy versus an existing one (pembrolizumab) with chemotherapy.
  • Aims to understand which treatment is safer and more effective.
  • Careful monitoring of patient health and cancer progress will be part of the study.

Who may be eligible?

To join this study, participants generally need to be at least 18 years old and have non-small cell lung cancer that is either locally advanced (meaning it can't be removed by surgery) or has spread to other parts of the body. You must not have received any previous treatment specifically for this advanced stage of lung cancer. Doctors will also check your overall health, including heart and organ function, to make sure you are well enough to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have non-small cell lung cancer that is advanced or has spread?
  3. Have you NOT had previous drug treatment for this advanced cancer?
  4. Are you generally feeling well and able to manage daily activities?
  5. Have you been tested for certain gene changes like EGFR or ALK and found not to have them?
  6. Do you NOT have serious heart problems or active autoimmune conditions?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two treatment groups, meaning you'll get either tobemstomig or pembrolizumab, both with chemotherapy. You'll have regular hospital visits for your treatments and check-ups, which will include blood tests, scans, and other assessments to monitor your health and how the treatment is working. The exact number of visits and the total duration will be explained by the study team, but clinical trials usually involve ongoing follow-up for a period after treatment ends. You'll need to provide tissue samples for the researchers to understand your tumour better and track your progress.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like access to new treatments before they are widely available. However, there are also potential risks, as any medicine can cause side effects. Some side effects might be mild, while others could be more serious or even unknown, as tobemstomig is a new drug. The study team will explain all known risks. Your safety is most important, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

  • Henry Ford Health System
    Verified postcode
    Detroit, United States
  • Renown Regional Medical Center Hospital
    Verified postcode
    Reno, United States
  • Westmead Hospital
    Verified postcode
    Westmead, Australia
  • Lyell McEwin Hospital
    Verified postcode
    Adelaide, Australia
  • Barwon Health
    Verified postcode
    Geelong, Australia
  • Monash Health
    Verified postcode
    Melbourne, Australia
  • UZ Brussel
    Verified postcode
    Brussels, Belgium
  • Jessa Zkh (Campus Virga Jesse)
    Verified postcode
    Hasselt, Belgium
  • UZ Leuven Gasthuisberg
    Verified postcode
    Leuven, Belgium
  • AZ St Maarten Campus Leopoldstr
    Verified postcode
    Mechelen, Belgium
  • Crio - Centro Regional Integrado de Oncologia
    Verified postcode
    Fortaleza, Brazil
  • Nucleo de Oncologia da Bahia - NOB
    City only
    Salvador, Bahia, Brazil

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and there are different ways it can be advanced or spread.

What does 'untreated' mean in this study?

It means you haven't had any previous drug treatments for your advanced lung cancer.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells, often given through a drip.

What are tobemstomig and pembrolizumab?

These are both immunotherapy drugs that help your body's own immune system fight the cancer.

Will I know which treatment I am getting?

The study design will determine if you or your doctor will know which treatment you are receiving. The study team can explain this fully.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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