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EXCLAIM-2 Clinical Study

Investigating a Potential Treatment Option for People with Non-Small Cell Lung Cancer Whose Cancer is Positive for EGFR Exon 20 Insertion Mutations and Who Have Not Yet Been Treated.

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About the EXCLAIM-2 Clinical Study

The EXCLAIM-2 Clinical Study is an investigational study testing the safety and effectiveness of an investigational medication versus platinum-based chemotherapy for patients with non-small cell lung cancer (NSCLC) with tumors that are positive for an EGFR exon 20 insertion mutation who have not yet been treated.

Patients

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We are looking for potential participants who have not received previous treatment for locally advanced or metastatic NSCLC with an epidermal growth factor receptor (EGFR) exon 20 insertion mutation:

Caregivers

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We are looking for potential participants who have not received previous treatment for locally advanced or metastatic NSCLC with an EGFR exon 20 insertion mutation. If your loved one may qualify:

Healthcare Providers

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Learn about a clinical study with an investigational first-generation EGFR TKI specifically designed to target non-small cell lung cancer tumors that are positive for EGFR exon 20 insertion mutations.

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

NSCLC is the most common form of lung cancer, accounting for approximately 80-85% of all lung cancers. There are a number of different genetic mutations associated with NSCLC – making it complex to study, diagnose and treat. 1-2 One of these is a mutation in the epidermal growth factor receptor (EGFR) gene.

What are EGFR Exon 20 insertion mutations?

EGFR mutations are found in approximately 15-40% of patients with NSCLC, with increased frequency in Asian patients.1-3 Testing positive for the EGFR mutation means that the EGFR protein that’s normally present on the surface of lung cells is mutated or damaged, making it an abnormal protein. The abnormal EGFR protein performs irregularly, causing uncontrollable cell growth that can lead to cancer.4

Exon 20 insertion mutations are different from other EGFR mutations. This mutation occurs in a specific region of the EGFR protein called exon 20. Insertions are extra amino acids (proteins are made up of amino acids) that are added to the EGFR protein and cause irregular function.4

In the United States, EGFR exon 20 mutations occur in approximately 2.5-9% of all EGFR mutations in NSCLC.5,6 Therefore, patients with NSCLC who have EGFR exon 20 insertion mutations make up a small proportion of the NSCLC population, and there are currently no targeted therapy options to treat them, as approved EGFR tyrosine kinase inhibitors were not designed for patients with this subtype of EGFR mutations. Targeted therapies are a type of investigational medication that blocks the growth and spread of cancer cells by targeting specific genes, proteins, or the tissue environment that contributes to the growth, progression and survival of cancer. (see https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet) The EXCLAIM-2 Clinical Study is investigating a potential medication for treating NSCLC patients who have not received prior treatment and whose tumors show an abnormal EGFR protein with an EGFR exon 20 insertion mutation.

rectangle representing EGFR protein with arrows indicating the location of an exon 20 insertion mutation and a chain of circles representing amino acids on an EGFR protein with and without mutations

If you don’t know your or your loved one’s specific mutation status, talk to your doctor about genetic testing, or if you have been diagnosed with an EGFR mutation, ask your doctor if it’s specifically an EGFR exon 20 insertion mutation. Getting tested is required in order for your doctor to help you determine if this study might be right for you or your loved one.

1. American Cancer Society. What is Non-Small Cell Lung Cancer? https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed August 2019. 2. Kris MG, et al. JAMA, 2014;311:1998-2006. Accessed October 2019. 3. Kohno T, Nakaoku T, Tsuta K, et al. Beyond ALK-RET, ROS1 and other oncogene fusions in lung cancer. Transl Lung Cancer Res. 2015;4(2):156-164. 4. Vanderbilt University Medical Center. Lung Cancer and EGFR Exon 20 Insertion Mutations. https://mc.vanderbilt.edu/ckm/gl/mutation_profiles/pdfopen.php?fnp=lung_cancer/content/EGFR Lung_Cancer_and_EGFR_Exon_20_ Insertions.pdf. March 2016. Accessed July 26, 2019. 5. Oxnard GR, Lo PC, Nishino M, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013;8(2):179-184. 6. Arcila ME, Nafa K, Chaft JE, et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013;12(2):220-229.

icon of a checklist with orange, green, and blue circles

Take the EXCLAIM-2 Eligibility Quiz to see if you or your loved one may be eligible to enroll.

Please speak with your doctor if you’re unsure about your or your loved one’s specific mutation status. (If you are filling this out on behalf of the patient, please answer based on the patient’s information.)

1.
Are you at least 18 years or older?

Yes

No

1/4

2.
Have you been diagnosed with stage IV NSCLC?

Yes

No

2/4

3.
Have you tested positive specifically for the EGFR exon 20 insertion mutation?

Yes

No

3/4

4.
Have you previously been treated for locally advanced or metastatic NSCLC?

Yes

No

4/4

Thank you

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Unfortunately, at this time you haven’t met the eligibility requirements to enroll in the EXCLAIM-2 Clinical Study. If you’ve never tested for an EGFR exon 20 insertion mutation, it’s a requirement in order to be eligible. Ask your doctor about getting tested. Please use the Doctor Discussion Guide below to talk to your doctor about your options and to find out whether additional genetic testing is appropriate.

Download Doctor Discussion Guide

What can I expect?*

All investigational clinical trials have specific requirements set by the study team. These requirements allow the team members to collect data on the potential first-line investigational medication from patients who have a similar background upon entering this clinical trial. If you are ineligible for the EXCLAIM-2 study, talk to your doctor about other potential clinical studies that may be available to you. To learn more about the patient population in this study, click here.

*This is not a full list of the requirements, however, you may be eligible to enroll if you meet all of the following:

  • Aged 18 years or older

  • You have not received previous treatment for locally advanced or metastatic NSCLC

  • You’ve tested positive for EGFR exon 20 insertion mutation

  • Your doctor believes you are fit for a clinical study

  • If you have brain metastases, they must be treated with surgery and/or radiation and have been stable without need for steroids within 7 days of starting the study

See the full list of requirements and details about the EXCLAIM-2 study here.

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Find study locations in your area

Additional Resources

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A clinical study recruits volunteers in order to determine the safety and efficacy of an investigational medication based on guidelines set by investigators (often medical doctors). This helps inform doctors about the investigational medication, diagnosis, and effect on the disease. Depending on the investigator, clinical studies can take place in many locations like hospitals, universities, doctors’ offices, and community clinics.1

Investigators design a clinical study when they believe that a potential investigational medication could benefit patients. Before it’s made available to the public, the potential investigational medication goes through phases of research to ensure it’s safe and effective. This process takes time and relies heavily on volunteers who meet the clinical study requirements to participate.2

phase one

Participants are tested to evaluate the safety, dosage, and side effects of a drug.

phase two

Investigators want to determine the effective dosage range for participants while monitoring the safety of the potential investigational medication.

phase three

Participants are randomly assigned to the investigational medication group or a control group. Investigators monitor the side effects and the effectiveness of the potential investigational medication.

phase four

Once an investigational medication has been approved by the Food and Drug Administration (FDA) or another country’s regulatory authority and made available to consumers, a Phase IV, or post-marking study, may be conducted to survey the safety and effectiveness of the approved medication in participants over long periods of time.

Participating in a clinical study helps advance the medical knowledge of the disease, which could help you or your loved one and others who have the same condition.1

Normally, the study investigational medication, other medical needs, and sometimes travel expenses are provided to participants at no cost.1

A person’s eligibility for a clinical study is based on certain factors such as age, gender, type and stage of disease, investigational medication history, and other medical conditions.1

To help determine whether enrolling is right for them, those interested in participating will receive full information on the study and what they may expect throughout the process from a study coordinator. Participants will also be asked to sign an informed-consent document before proceeding to a screening phase, where coordinators will conduct additional tests to see if participants meet medical requirements for study entry. This screening process could take approximately 2-3 weeks.

Participants who agree to move forward with the study also have the choice to withdraw from the study at any time, even if the study has not ended.

You have every right to ask any questions before choosing to participate in a clinical study. Here are some important questions you may want to ask:

  • What will this drug be used for?

  • Do I meet all the requirements for this study?

  • What are the possible risks?

  • What are the potential benefits?

  • How do I prepare for this study?

  • What can I expect from this study?

  • How long does the study last?

Informed consent is a step you take before participating in a clinical trial that explains the risks and potential benefits of the study's investigational medication.1 You will receive facts and information about the study that should help you decide if you want to participate.

It’s important to remember that participating in a clinical study is voluntary. You can choose to discontinue from the study at any time even after the informed consent has been signed.

Every clinical study is monitored by an Institutional Review Board (IRB) or Ethics Committee. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.

Participants also have the right to discontinue the study at any time for any reason.

The doctor may still check your or your loved one’s health for a period of time after discontinuing, but there will no longer be any obligation to continue participating in the study.

There are risks associated with all clinical studies. During the informed-consent process, the participant and a member of the study team will go over the details of the study, possible risks or side effects. It’s important to be aware that while participating in a clinical research study, you or your loved one’s condition may stay the same, may get worse, or may improve. It’s important to inform the study team if any significant changes in health, good or bad, occur while participating in the study.

1. National Institute of Health. U.S. National Library of Medicine. What is a clinical study? https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs. March 2019. Accessed July 26, 2019. 2. National Comprehensive Cancer Network. Patient and Caregiver Resources. https://www.nccn.org/patients/resources/clinical_trials/phases.aspx. Accessed July 26, 2019.

Actor portrayal.

Doctor Discussion Guide

Talking to your doctor about non-small cell lung cancer (NSCLC) and the EXCLAIM-2 study

The EXCLAIM-2 Clinical Study is an investigational study testing the safety and effectiveness of an investigational medication for patients with NSCLC with tumors that are positive for an EGFR exon 20 insertion mutation who have not received prior treatment.

You may feel overwhelmed to ask detailed questions at an appointment, and that’s okay. Your doctor is there to support you and welcomes any questions. It’s crucial that when communicating with your doctor, you make sure to get all your questions answered before leaving the office so you can find the best path forward. One good strategy is to repeat or write down what you’ve learned from your doctor to ensure there is no misunderstanding. Your doctor is your best source of information specific to your diagnosis.

To help start the conversation, below are examples of questions you may want to ask during your next appointment to discuss whether the EXCLAIM-2 clinical study may be an option for you.

Download

Patient Eligibility Requirements*

*This is not a complete list of eligibility criteria.

Before making a decision regarding study enrollment, please consult the complete list here.

  • Male or female participants who are at least 18 years old

  • Have not received previous treatment for locally advanced or metastatic NSCLC

  • Must have measurable disease by response evaluation criteria in solid tumors (RECIST v1.1)

  • Tested positive for EGFR exon 20 insertion mutation and sufficient tumor tissue available for central analysis

  • Adequate organ function at baseline

  • Minimum life expectancy of 3 months or more

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

  • Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected (Fridericia) (QTcF) of less than or equal to (≤) 450 milliseconds (ms) in males or ≤470 ms in females

  • Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days prior to the first dose of the study

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Find study locations in your area

Select your state

About EGFR Exon 20 Insertion Mutations

Oncogenic driver mutations, including EGFR mutations, are known to cause approximately 50% of NSCLC cases.1,2 Specifically, EGFR mutations are expressed in 15-40% of patients with advanced NSCLC.2,3

A more rare mutation, the EGFR exon 20 insertion, occurs in 2.5-9% of all EGFR mutations and these patients do not tend to respond to current EGFR tyrosine kinase inhibitors.4,5 Finding out about their exon 20 status through genetic testing may help determine whether they qualify for the EXCLAIM-2 Clinical Study evaluating the safety and efficacy an investigational tyrosine kinase inhibitor (TKI) for patients with NSCLC whose tumors have an EGFR exon 20 insertion mutation who have not yet received prior treatment.

pie chart of today’s most common oncogentic driver mutations

For your patients who have not received prior treatment and have not been tested for EGFR or have tested positive for EGFR, additional genetic testing can help confirm their exon 20 status. Ordering a test (preferably a Next-Generation Sequencing, [NGS], test) can help determine whether this study may be right for them.6,7

NGS testing is preferred since it finds all the exon 20 insertion variants. PCR testing is another alternative, however, PCR does not detect all variants of exon 20 insertions using tumor DNA.8

Additional Resources

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The EXCLAIM-2 Clinical Study is a Phase 3, open-label, multicenter, active-comparator, international study that plans to evaluate the safety and efficacy of an investigational tyrosine kinase inhibitor (TKI) as a first-line treatment versus platinum-based chemotherapy in approximately 318 patients with locally advanced or metastatic NSCLC whose tumors express EGFR exon 20 insertions. Participants will be administered the experimental medication at 160 mg once daily or chemotherapy intravenously.

The full inclusion criteria for the EXCLAIM-2 Clinical Study are available here.

Genetic testing can help identify abnormal changes in your patients’ genes. Genetic tests, like NGS, analyze DNA to detect mutations that could lead to cancer.8,9

Targeted therapies differ from traditional chemotherapy and treat cancer by being able to target specific gene changes. These therapies can block the process that tells cancer cells to grow and divide or destroy cancer cells.10

Learn more about targeted therapies here.

NGS is a single test that determines the genetic sequence of multiple genomic targets. It also has the advantage to detect mutations that may be present at low levels in tumors. Detecting these mutations is generally difficult but critical in hematological and solid tumor malignancies. Typically, NGS provides you with a comprehensive genomic profile that could be used to help guide your investigational medication selection process.7,8

Order an NGS test that includes the ability to detect EGFR exon 20 for your patients, and see if they’re eligible for the EXCLAIM-2 Clinical Study.

PCR is a different testing technique that copies small segments of DNA in order to effectively conduct a genetic analysis. Different PCR tests can be used to detect insertions by identifying any mutation that differs from a normal sequence. However, PCR testing is currently limited to detecting a certain number of genes and genetic mutations. This can make it difficult to detect all the different types of EGFR exon 20 insertion mutations. This is why NGS is preferred.7,8,11

Learn more about the guidelines associated with genetic testing for NSCLC here.

1. Crossland V, Li S, Galaznik A. The Frequency and Spectrum of EGFR Exon 20 Insertions in NSCLC: A Global Literature Review. 2. Kris M, Johnson B, Berry L, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006. 3. Kohno T, Nakaoku T, Tsuta K, et al. Beyond ALK-RET, ROS1 and other oncogene fusions in lung cancer. Transl Lung Cancer Res. 2015;4(2):156-164. 4. Oxnard GR, Lo PC, Nishino M, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013;8(2):179-184. 5. Arcila ME, Nafa K, Chaft JE, et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013;12(2):220-229. 6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology Non-Small Cell Lung Cancer (Version 5.2019). https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 26, 2019. 7. Cancer Genetic Incorporated. Access the Next-Generation of Cancer Diagnostics. https://www.cancergenetics.com/laboratory-services/specialty-tests/focus-ngs/focus-overview/. Accessed July 26, 2019. 8. My Cancer Genome. Types of Molecular Tumor Testing. https://www.mycancergenome.org/content/page/molecular-testing/. Accessed July 26, 2019. 9. NIH U.S. National Library of Medicine. What is genetic testing? https://ghr.nlm.nih.gov/primer/testing/genetictesting. July 16, 2019. Accessed July 26, 2019. 10. Cancer.net. Understanding Targeted Therapy. https://www.cancer.net/navigating-cancer-care/how-cancer-treated/personalized-and-targeted-therapies/understanding-targeted-therapy. January 1, 2019. Accessed July 26, 2019. 11. National Human Genome Research Institute. What is PCR? https://www.genome.gov/about-genomics/fact-sheets/Polymerase-Chain-Reaction-Fact-Sheet. Accessed July 26, 2019.

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