RecruitingPHASE2INTERVENTIONAL

Using ctDNA to Determine Therapies for Lung Cancer

This research is for people who have had lung cancer removed by surgery. Sometimes, even after successful surgery, a tiny amount of cancer might be left behind, which could lead to the cancer returning. This study uses a blood test to check for 'circulating tumour DNA' (ctDNA) – these are tiny pieces of cancer DNA found in the blood. If ctDNA is detected after surgery, the study aims to find out if giving additional treatments, like certain medications (such as Nivolumab or chemotherapy drugs like Pemetrexed, Gemcitabine, Cisplatin, Carboplatin), can reduce the chance of the cancer coming back. The main goal is to understand if this blood test can help doctors decide which patients would benefit most from extra treatment after surgery.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

28 Mar 2022

Estimated completion

01 Dec 2026

Non Small Cell Lung Cancer Complete Surgical Resection Circulating Tumor DNA

What is this study about?

When people have an early stage of a type of lung cancer called non-small cell lung cancer, the main treatment is usually an operation to remove the cancer. For many, this surgery is all that's needed to get rid of the cancer completely. However, sometimes a few cancer cells might remain in the body that are too small to be seen. If these cells are left behind, they can grow and cause the cancer to return later on. This is what doctors call a 'relapse'.

To try and spot these leftover cancer cells, scientists have developed a special blood test. This test looks for tiny fragments of DNA that cancer cells shed into the bloodstream, called 'circulating tumour DNA' (ctDNA). Think of it like a very sensitive detector looking for microscopic hints that cancer might still be present. Some early studies have suggested that if ctDNA is found in the blood after surgery, it might mean there's a higher chance of the cancer coming back.

This study wants to explore this idea further. If the ctDNA blood test shows that some cancer cells might still be around after surgery, the researchers want to see if giving extra treatment (which doctors call 'adjuvant treatment') can help prevent the cancer from returning. This could involve different medications. The hope is that this research will help doctors in the future to better understand who needs extra treatment after surgery and who doesn't, making treatments more targeted and effective.

Key takeaways

This study uses a special blood test to find tiny cancer DNA fragments (ctDNA) after lung cancer surgery.
If ctDNA is found, the study looks at whether extra treatments can help stop the cancer from returning.
It aims to improve how doctors decide who needs more treatment after surgery for non-small cell lung cancer.
Treatments include an immunotherapy drug (Nivolumab) or chemotherapy.
You must have had complete surgery for your lung cancer and meet certain health criteria to be eligible.
Participation involves regular hospital visits, blood tests, and receiving study treatment, with careful follow-up.

Who may be eligible?

To join this study, you need to be at least 18 years old and generally feel well enough to take part. You must have had a complete operation to remove your non-small cell lung cancer, and this is the first time you've had treatment for this cancer (no previous chemotherapy or radiotherapy for this particular cancer). Your doctor will also check that your organs are working well enough for you to safely join the study.

A key part of joining is that the special ctDNA blood test must find traces of cancer DNA in your blood either before or after your surgery. This study is specifically for people where these tiny cancer DNA fragments are detected. If doctors would normally give you chemotherapy after surgery, you might not be suitable for this study.

If you are a woman who could become pregnant, or a man whose partner could become pregnant, you will need to agree to use effective contraception during the study and for a period afterwards to prevent pregnancy. This is a common precaution in many drug trials.

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 had surgery to completely remove your non-small cell lung cancer?
Have you *not* had chemotherapy or radiotherapy for this particular lung cancer previously?
Do you feel generally well and active enough for daily tasks?
Has a ctDNA blood test (before or after surgery) found tiny traces of cancer DNA in your blood?
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 join this study, you will have several visits to the hospital for assessments. This will likely involve regular blood tests, including the special ctDNA test, and other checks to monitor your health and how the treatment is working. Depending on which treatment group you are in, you would receive either the immunotherapy drug Nivolumab or one of the chemotherapy combinations (Pemetrexed, Gemcitabine, Cisplatin, or Carboplatin). The specific schedule and number of treatments will be explained by the study team.

After your treatment period, you will have follow-up appointments to track your health and see if the cancer has returned. The study will likely involve regular check-ups for a significant period to monitor long-term outcomes. The study team will explain the full schedule of visits, medication administration, and follow-up, along with the total expected duration of your active participation and monitoring.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit of this study is that the additional treatment you receive might help reduce the chance of your lung cancer coming back, based on the results of the special blood test. You would also be contributing to important research that could improve future care for people with lung cancer. However, the treatments being explored, like any medications, can have side effects. Your study doctor will explain all known side effects for Nivolumab and the chemotherapy drugs. There is also the potential for unknown side effects, as this is a research study. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'ctDNA'?

CtDNA stands for 'circulating tumour DNA'. It's tiny pieces of genetic material that cancer cells release into your bloodstream. A special blood test can detect these tiny fragments.

Why is this blood test important?

This blood test might help doctors understand if there are still some cancer cells in your body after surgery, even if they're too small to see. This could help decide if you need more treatment to stop the cancer from coming back.

What is 'adjuvant treatment'?

Adjuvant treatment is extra treatment given after an initial main treatment (like surgery). The goal is to kill any remaining cancer cells and lower the risk of the cancer returning.

Will I definitely get the new drug?

Not necessarily. This study tests different treatments, including established chemotherapy drugs and an immunotherapy drug called Nivolumab. You will be assigned to a specific treatment plan determined by the study design.

Can I choose not to take part?

Absolutely. Taking part in a research study is completely voluntary. You can decide not to join, or you can withdraw at any time without it affecting your medical care.

How to find out more

Natasha Leighl, M.D.

natasha.leighl@uhn.ca 416-946-4645 Official trial record

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