About NSCLC & Biomarkers
About NSCLC &
Biomarkers
About NSCLC
About Biomarkers
Understanding Biomarkers Why Get Tested FAQs
About Clinical
Research Studies
Understanding Clinical Research Why Participate FAQs
Current Clinical
Research Studies
Current Studies
Chrysalis Study Chrysalis 2 Study Mariposa 2 Study Papillon Study
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About NSCLC

Non-Small-Cell Lung
Cancer (NSCLC)

NSCLC is the most common type of lung cancer, accounting for more than 8 out of 10 cases. Like all lung cancers, it is caused by changes (or mutations) to your genes that can cause lung cells to grow or multiply more than they should. Eventually, those extra cells cluster together and form tumours that lead to lung cancer. Unlike normal cells, cancer cells grow without order or control.

EGFR-Positive NSCLC

Epidermal growth factor receptor (EGFR) is a protein found on the surface of healthy cells that help your cells grow and divide. Mutations to the gene that controls the EGFR protein can cause cancer cells to grow and multiply in the body. EGFR-positive NSCLC is NSCLC that has tested positive for a mutation in this gene.

There are both common and rare EGFR mutations:
  • More common EGFR mutations (85%-90%) are Exon 19 deletion and Exon 21 L858R substitution. Deletions are the removal of DNA, which can change the way the EGFR gene works.1 Substitutions are the replacement of one piece of DNA with another, which can also change the way the EGFR gene works.1
  • A rare EGFR mutation is the Exon 20 insertion, which accounts for a small proportion of the NSCLC population. An exon (such as Exon 20) is a specific part of the EGFR gene. Insertions are additional DNA that is added to the EGFR gene, causing it not to work the way it should.1

Visit this page to learn how biomarker testing can determine mutation types.

Until recently, most NSCLC was treated similarly, with therapies that destroy dividing cells (both cancer and healthy cells alike). Today, clinical research studies are evaluating the safety and efficacy of investigational medicines (with the goal of targeting certain mutations) to potentially treat NSCLC.

Consider participating in a Janssen research study today.

See If You Are Eligible

SOURCES:

1 evolution.berkeley.edu/evolibrary/article/0_0_0/mutations_03
About Biomarkers

Understanding
Biomarker Testing

This information will help you understand what a biomarker is and how biomarker information will be used to determine eligibility in certain Janssen clinical research studies.

Biomarkers

In the past, most types of non-small-cell lung cancer (NSCLC) were treated similarly. Today, researchers know that just as people with NSCLC are all different, so are their tumours. In some cases, doctors can use information about a patient’s tumour to help decide what option may be right for them. This information is called a biomarker.1
A biomarker is an identifier of a process, condition, or disease in one’s body.2

The role of biomarkers
in research studies

Biomarkers can be used to determine if you are a good candidate for research studies that are evaluating an investigational medicine for NSCLC. These research studies are seeking to target cancer cells that are caused by changes (or mutations) in specific genes, while leaving normal cells alone.3 By looking for certain biomarkers, healthcare professionals can find out which mutations are causing your NSCLC.

Testing for
biomarkers

Biomarkers are identified through genetic testing. Your doctor will take a tumour tissue or blood sample and test it in a lab. They will then look for biomarkers to determine which mutations are causing your NSCLC.4

How biomarker test results are used

The results of a biomarker (genetic) test can determine whether you may be eligible to participate in a certain research study. They can also provide insight into whether your NSCLC is more likely to respond to certain treatments. In this way, getting a biomarker test and reviewing the results can help you and your medical team identify potential options or clinical research studies that may be right for you.

Download Biomarker Information
Watch this video to learn more about biomarker testing.
ASK YOUR DOCTOR

This discussion guide contains information on biomarker testing that you can use when you speak to your doctor.

Download Discussion Guide
Why Get Tested

It is important to speak with your doctor about getting a biomarker test in order to find out which genetic mutations are causing your NSCLC.

  • NSCLC is caused by changes (or mutations) in your genes that can cause your lung cells to grow or multiply more than they should. Eventually, those extra cells cluster together and form tumours that lead to lung cancer.

NSCLC with certain mutations are currently being studied in clinical research. The efficacy (if it works and if it can focus on the cancer cells, while leaving healthy cells alone) and safety of the investigational medicines are currently being evaluated.

Getting a biomarker test and reviewing the results with your doctor can help you and your doctor better understand your potential options. Your results may also provide an opportunity for you to participate in clinical research.

FAQs
What is a biomarker?

A biomarker is anything that can be measured in tissue, blood, or other bodily fluids, to identify an activity or condition in your body. Your blood pressure and body temperature are examples of biomarkers that can tell your doctor how your body is doing.

Biomarkers can be used to:

  • Determine whether a disease or condition is present
  • Determine how aggressive the disease is
  • Predict how well the body will respond to a treatment for a disease or condition
What is biomarker testing?

Biomarker testing (also known as mutation, genomic, or molecular testing) uses tumour tissue samples or blood samples to help your healthcare team gather as much information as possible about your specific lung cancer and its causes.

Why is biomarker testing important to people with NSCLC?

Biomarker test results can help determine whether your lung cancer can be treated by a “targeted” therapy formulated for your specific kind of NSCLC. The results of a biomarker test may also provide an opportunity for you to participate in a certain research study.

Who should I talk to about getting a biomarker test?

Talk to your doctor or medical team about getting a biomarker test any time after your diagnosis. It’s never too soon to ask about biomarker testing, because the results can help personalize your treatment right from the start. They may also provide an opportunity for you to participate in a certain research study.

Download Patient Downloadable Discussion Guide
How is a biomarker test conducted?

There are two ways to administer a biomarker test: by taking a tumour tissue sample, or by taking a blood sample.

tumour tissue testing, known as a tissue biopsy, is the most common procedure. There are a number of different ways to take a tumour tissue sample. The one you and your team choose will depend on the location and size of the tumour, as well as your overall health. Tissue from the tumour is saved for a long time, so that additional testing, if necessary, can often be done without the need for another sample.

In certain situations, your doctor may use a blood sample instead of a tissue sample. This is known as a liquid biopsy and is conducted by drawing blood.

What do doctors look for in a biomarker test report?

Two of the main things your healthcare team will look for when they get the results of your biomarker test are whether or not a mutation is affecting your NSCLC, and if so, whether potential options are available specifically for NSCLC with that particular mutation. NSCLC with certain mutations are currently being studied in clinical research and the results from a biomarker test can help determine eligibility for these studies.

What are some questions to ask my healthcare team about biomarker testing?

Before getting a biomarker test:

  • How will the test be administered?
  • What do I need to do to prepare for the test?
  • How long will it take to get the results?
  • Will insurance pay for these tests?

After getting a biomarker test:

  • What are the results of these tests?
  • How will the results affect my treatment?
  • Are there any medications that target my type of lung cancer?
  • Are there any clinical research studies open to me based on these results?

SOURCES:

1 lungcancer.org/find_information/publications/94-lung_cancer_new_tools_for_making_decisions_about_treatment 2 cancer.gov/publications/dictionaries/cancer-terms/def/biomarker 3 lungevity.org/for-patients-caregivers/lung-cancer-101/treatment-options/targeted-therapy 4 verywellhealth.com/lung-cancer-with-an-egfr-mutation-4097338 cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/what-is.html webmd.com/lung-cancer/story/nsclc-gene-mutations lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/learn-about-lung-cancer/how-is-lung-cancer-diagnosed/lung-cancer-tumor-testing lungevity.org/for-patients-caregivers/lung-cancer-101/diagnosing-lung-cancer/biomarker-testing lungevity.org/sites/default/files/biomarker/biomarker-flyer-052020.pdf cancer.org/cancer/lung-cancer/about/key-statistics.html lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/learn-about-lung-cancer/lung-cancer-basics biologydictionary.net/exon/ medlineplus.gov/genetics/understanding/mutationsanddisorders/possiblemutations/ cancer.gov/publications/dictionaries/genetics-dictionary/def/insertion nature.com/scitable/topicpage/protein-structure-14122136/#:~:text=What%20Are%20Proteins%20Made%20Of,side%20chain%20(see%20below). genome.gov/genetics-glossary/Exon genome.gov/genetics-glossary/Substitution
If you have EGFR-Positive Non-Small-Cell Lung Cancer, your journey may include a different path. 

The more we learn, the farther we can go.