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A lung cancer clinical trial - BR36

A study of blood tests to determine treatment options for patients with non-small cell lung cancer
Disease Site
Lung Clinical Trials
Trial Code
BR.36 (CRI-CCTG-002) ǀ NCT04093167
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of the study is to identify which non-small cell lung cancer patients would benefit from the addition of chemotherapy to their standard immunotherapy treatment. Researchers want to understand if patients who have the chemotherapy added are getting maximum potential benefit with less risk of side effects.

A blood test will be given to identify who would benefit from added chemotherapy by using circulating tumour DNA (ctDNA), which is DNA shed by the patient’s cancer.
 

Why is this study important?

For some people, immunotherapy treatments do not provide a long response to treatment. The study will use ctDNA testing to identify patients who might have a longer treatment response. This means that decisions about continued immune treatments or adding chemotherapy can be completed before other testing shows the cancer is getting worse, improving patient outcomes.

Also, researchers hope that mutations found by ctDNA and tumour tissue testing may assist with planning subsequent treatments and trial opportunities.
 

Who can participate in this study?

This trial is for patients:

  • with advanced non-small cell lung cancer on standard of care immunotherapy for whom there is no evidence that the cancer is worse 
  • that are well enough to receive chemotherapy

This trial is not for:

  • with other types of cancer
  • receiving chemotherapy, or experimental therapy
What are the risks?
  • If you choose to take part in this study, there is a small risk that the test results may be wrong. If these test results are wrong, you may be included in this study even though it may not offer the best treatment option for you. Or you may not be included in this study even though it may offer a good treatment option for you. You will receive the standard treatment for the type of cancer you have. The risks and side-effects of this standard treatment and procedures will be explained to you as part of your standard care and are therefore not listed here. You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, you will have blood taken to be analyzed to see if ctDNA is found in the blood. If ctDNA is present, you will complete the screening for the study and be added to one of two groups and you will either continue with immune therapy alone or you will have chemotherapy added which is the experimental treatment.
  • In both groups, treatment will continue until you or your doctor decide the treatment is no longer the best treatment for you.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The BR.36 (CRI-CCTG-002) study is currently enrolling patients at cancer centres in Canada and the United States. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT04093167. 
 

Use this trial information for your conversation with your health care team

Participating centres
  • Kingston Health Sciences Centre - Kingston, ON, K7L 2V7 - Contact: Dr. Sofia Genta
  • Ottawa Hospital Research Institute - Ottawa, ON, K1H 8L6 - Contact: Dr. Sara Moore
  • Juravinski Cancer Centre at Hamilton Health Sciences - Hamilton, ON, L8V 5C2 - Contact: Dr. Rosalyn Anne Juergens
  • University Health Network Princess Margaret Cancer Centre - Toronto, ON, M5G 2M9 - Contact: Dr. Adrian Sacher
  • Health Sciences North - Sudbury, ON, P3E 5J1 - Contact: Dr. Lacey Diane Pitre
  • Algoma District Cancer Program Sault Area Hospital - Sault Ste. Marie, ON, P6B 0A8 - Contact: Dr. Michela Febbraro
  • BCCA - Vancouver - Vancouver, BC, V5Z 4E6 - Contact: Dr. Cheryl Ho