RecruitingPHASE2INTERVENTIONAL

An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer

This study is investigating a new form of a well-known chemotherapy medicine, called SMS001, for patients with a specific type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). The main goals are to determine the safest and most effective dose of SMS001 and to observe how well it performs in treating the cancer. Researchers will also be checking if SMS001 helps prevent the cancer from returning after surgery, which is a key part of fighting lung cancer. This work aims to find better ways to help patients recover and stay healthy after their cancer treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

ToLymph Inc.

Enrolment target

Start

18 Nov 2024

Estimated completion

30 Dec 2026

Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)

What is this study about?

This study is looking into a new way to treat non-small cell lung cancer, which is the most common type of lung cancer. It involves a new version of a medicine called paclitaxel, which we're calling SMS001 in this study. Paclitaxel is a chemotherapy drug that's already used to treat various cancers, but researchers are hoping this new form might be even better or safer.

The main idea behind this study is to find the right dose of SMS001 for patients who have had surgery for their lung cancer. Finding the right dose is important because it ensures the medicine is effective against the cancer while keeping side effects to a minimum. After finding the safest dose, the doctors will then carefully watch how well the medicine works over time.

Specifically, they want to see if SMS001 can help prevent the cancer from coming back within a year after surgery. They will also be looking at how long people stay free from the cancer (this is called 'disease-free survival'). By doing this, the researchers hope to understand if SMS001 can offer a valuable new treatment option for lung cancer patients, helping them to live longer and healthier lives after their initial treatment.

Key takeaways

Tests a new form of a known chemotherapy drug (SMS001) for lung cancer.
Aims to find a safe dose and see how well it works after surgery.
Focuses on preventing cancer recurrence and improving disease-free survival.
Involves regular check-ups and monitoring.
Open to adults with specific stages of non-small cell lung cancer.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to be an adult aged 18 to 80 years old and have a confirmed diagnosis of non-small cell lung cancer. Your cancer should be at certain early to mid-stages (Stages Ib, IIa, IIb, or some Stage IIIa) and you must be considered suitable for lung cancer surgery. This means that a surgeon believes they can completely remove the cancer.

It's important that you haven't had any chemotherapy or radiation therapy to your chest area before starting this study. Your body's systems, like your liver, kidneys, and blood, need to be working well, and specific blood test results will be checked to make sure you're healthy enough for the treatment. Also, because the exact doses are still being worked out, your heart health will be checked to make sure it can cope with the medication.

Both men and women can take part. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you'll need to use very effective contraception during and for a period after the study treatment. This is to make sure there's no risk to a baby. You'll also need to be willing to follow all the study instructions and understand what's involved before you agree to participate.

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 between 18 and 80 years old?
Have you been diagnosed with non-small cell lung cancer (Stages Ib, IIa, IIb, or IIIa)?
Are your doctors planning surgery to completely remove your lung cancer?
Have you *not* had chemotherapy or radiation to your chest before?
Are your liver, kidney, blood counts, and heart function generally good?
Are you able to use effective contraception if you or your partner could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study drug, SMS001, after your lung cancer surgery. The study involves regular check-ups with the doctors and nurses. These visits will include various tests, such as blood tests, and imaging scans (like X-rays or CT scans) to monitor your health and how your body is reacting to the treatment. The main part of the study will involve finding the right dose and then observing your progress.

The researchers will follow your health for a significant period. They'll specifically check for any signs of the cancer returning, with a focus on a 12-month check-up after treatment. The total duration of your involvement, including follow-up, will be determined by the study plan, but some checks regarding disease-free survival will continue until the very end of the study. You'll need to be available for these regular appointments to ensure the doctors can gather all the necessary information.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment, SMS001, which might be more effective or have different side effects than standard treatments. However, like all medicines, SMS001 may have side effects, which doctors will carefully monitor. Since this is an investigational drug, not all side effects are fully known yet. There's also no guarantee that the treatment will work for everyone, or that it will be better than existing treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

It's the most common type of lung cancer, and this study focuses on specific stages that are often treated with surgery.

What is SMS001?

It's a new version of a chemotherapy drug called paclitaxel. Doctors are testing it to see if it works better or differently.

Why are doctors doing this study?

They want to find a safe and effective dose of SMS001 and see if it can help prevent lung cancer from coming back after surgery.

Will I have to pay to be in the study?

No, you should not have to pay for the study drug or any study-related tests or appointments.

What happens after the study ends?

Your doctors will discuss your ongoing care and any future treatment options with you, based on your individual needs.

How to find out more

Jennifer Lister / Clinical Research Coordinator / UHN

jennifer.lister@uhn.ca 1-416-340-4857 Official trial record

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