Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase I Clinical Study to Assess Safety and Efficacy of Repotrectinib Combined with Osimertinib in Patients with Advanced, Metastatic EGFR Mutant NSCLC (TOTEM).

This study, called TOTEM, is an early-stage clinical trial looking at a new way to treat advanced non-small cell lung cancer (NSCLC). This type of lung cancer has spread to other parts of the body and has a specific gene change called an EGFR mutation. Researchers want to find out if combining two existing medicines, repotrectinib and osimertinib, is safe to use together and if it helps patients. This is a "Phase I" study, meaning it's one of the first times these treatments are being used in combination in humans, to carefully check for side effects and how the body reacts. The goal is to see if this combination could be a promising new treatment option for people with this type of lung cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Instituto Oncologico Dr. Rosell S.L.

Enrolment target

Start

23 Jul 2024

Non-small cell lung cancer (NSCLC)

What is this study about?

This study is called TOTEM, and it's an important step in developing new treatments for advanced non-small cell lung cancer (NSCLC). If you or someone you know has this type of lung cancer, you might know that it can sometimes spread to other parts of the body, and it might have a specific genetic change called an EGFR mutation. These mutations can make standard treatments less effective over time. That's why researchers are constantly looking for new and better ways to fight the disease.

In this study, doctors are investigating whether combining two medicines, repotrectinib and osimertinib, could be a helpful approach. Both of these medicines already exist, but they haven't been widely used together in this specific way before. Repotrectinib is a type of drug that targets certain changes linked to cancer growth, and osimertinib is also a targeted therapy commonly used for EGFR-mutated lung cancer.

This is a "Phase I" study, which means it's an initial look at this treatment combination in people. The main goals at this stage are to carefully check for safety – understanding any side effects and how the body handles the medicines – and to see if there are early signs that the combination is effective in treating the cancer. The information gathered from studies like TOTEM helps doctors and scientists decide if a new treatment is promising enough to move on to larger studies in the future, with the hope of eventually offering more options to patients.

Key takeaways

This is an early-stage study for advanced non-small cell lung cancer with specific gene changes.
It's testing a combination of two existing medicines: repotrectinib and osimertinib.
The main goals are to check for safety and see if the combination is effective.
Participation involves regular clinic visits for monitoring and taking study medication.
You can withdraw from the study at any time.
It helps develop potential new treatments for the future.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have been diagnosed with advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Your cancer would also need to have a specific genetic change called an EGFR mutation. Doctors will typically test for these mutations as part of your diagnosis.

There will be other detailed criteria that medical staff will check, such as your overall health, other medical conditions you might have, and previous treatments you've received. These checks are important to ensure your safety if you take part in the study.

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.

Are you 18 years old or older?
Have you been diagnosed with non-small cell lung cancer that has spread?
Does your lung cancer have an EGFR gene mutation?
Are you able to attend appointments regularly?
Are you willing to consider taking two study medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be closely monitored by a team of medical professionals. Initially, you would have several visits to the clinic for various assessments, which might include blood tests, body scans to check on your cancer, and physical examinations. You would be given the study medications, repotrectinib and osimertinib, according to a specific schedule, which you would take at home.

Throughout the study, you would continue to have regular follow-up appointments. These appointments are essential for the medical team to check how you are responding to the treatment, monitor for any side effects, and make sure you are feeling okay. The total length of your participation would depend on how you respond to the treatment and what the study doctors decide is best for you, but generally, early-stage studies have close follow-up for a period, with continued monitoring as needed.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment combination that could help your cancer, possibly even better than existing options. However, it's also possible that the treatment might not work for you, or you could experience side effects. All medications have side effects, and combining two treatments might lead to different or more pronounced effects. The study team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is non-small cell lung cancer?

Non-small cell lung cancer is the most common type of lung cancer. It's often found in later stages and can have different genetic changes, like the EGFR mutation focused on in this study.

What is an EGFR mutation?

An EGFR mutation is a specific change in the genes of cancer cells that can make the cancer grow and spread. Medicines called 'targeted therapies' are often designed to block the effects of these mutations.

What does 'Phase I' mean?

A Phase I study is an early stage of clinical research. Its main purpose is to test the safety of a new treatment or combination of treatments in a small group of people, and to find the right dose.

Are the medicines new or already used?

Both repotrectinib and osimertinib are existing medicines. This study is mainly looking at whether combining them works safely and effectively for this specific type of lung cancer.

Will my cancer be cured?

This study is testing a new treatment and cannot guarantee a cure. The aim is to find out if this combination can effectively treat the cancer and improve patient outcomes.