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Get ahead of standard treatments for non-small cell lung cancer. Participating in a non-small cell lung cancer clinical trial gives you access to the latest therapies.

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      Find Your Treatment Now

      A Patient Advocate will reach out to you soon.

      Your personal data is fully confidential and 100% secure

      You can receive a guidebook with information about lung cancer by filling out the form.

      Understanding Your Treatment Options for Advanced NSCLC With Gene Mutations

      If you have stage III NSCLC and you are ALK-positive, ROS1-positive, or RET fusion-positive, we can help you find new treatments.

      NSCLC treatment
      non small cell lung cancer

      Learning that your non-small cell lung cancer (NSCLC) has reached an advanced stage can be worrisome, but understanding your treatment options can restore confidence and offer hope. People with stage III NSCLC may be candidates for several different treatments, including therapies under study in clinical trials that are designed specifically for patients whose tumors are positive for changes (or mutations) called fusions in the ALK, ROS1, and RET genes. If you have stage III non-small cell lung cancer and have tested positive for these gene fusions, an NSCLC clinical trial might be the right treatment choice for you.


      What is Stage III NSCLC?

      NSCLC is the most common form of lung cancer. The stages of lung cancer run from stage 0 to stage IV, with higher stages representing more serious disease. If you have stage III NSCLC, cancer has spread from the lungs to nearby tissues or lymph nodes, but not to distant organs.


      How is Stage III NSCLC Treated?

      If you have stage III NSCLC, the treatment plan your doctor recommends will depend on several factors, including the size and location of the tumor, the results of lab tests, your overall health, and other therapies you have already had. You may be a candidate for one or more of the following treatments.

      • Surgery: Surgical removal of cancerous tumors.
      • Chemotherapy: A general term for drugs that kill cancer cells and prevent them from spreading.
      • Radiation therapy: The use of high-energy beams to destroy cancer cells.
      • Immunotherapy: Medications that stimulate the body’s natural defense network, the immune system, to find and destroy cancer cells.
      • Targeted therapy: Currently, a small number of patients with stage III NSCLC are candidates for targeted therapy, which is a type of medication that blocks or inhibits molecules that cause cancer to grow and spread.
      • Clinical trials: For some patients with stage III NSCLC, a lung cancer clinical trial may be the best treatment option. A clinical trial is a type of scientific study in which researchers evaluate a new medical therapy. Additional targeted therapies are being studied for the treatment of stage III NSCLC in patients with certain gene mutations, including ALK, ROS1, and RET gene fusionss.


      What are ALK, ROS1, and RET Fusion-Positive Genes?

      A gene is a basic unit of heredity passed down from a parent to a child. Genes are made up of DNA, which carries the instructions for making proteins that sustain life. Sometimes, when cells divide and make copies of themselves, errors called mutations occur in DNA, which in some cases increase the risk for disease. A fusion is a type of mutation that occurs when a gene joins together with another gene. ALK, ROS1, and RET are all genes that play a role in human development and supporting the health of cells. However, fusions in these genes have been shown to promote NSCLC. Mutations in other genes are also linked to this cancer.


      How Can I Find Out if I Have These Gene Fusions?

      If you don’t know whether you have ALK, ROS1, or RET positive fusions, or other gene mutations, a lab analysis of tissue from your tumor can make the determination. Tests used for this purpose include:

      • Fluorescence in situ hybridization (FISH)
      • Multiplex real-time PCR assay
      • Immunohistochemistry
      • Next-generation sequencing (NGS)
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      A Clinical Trial May Be an Option for You

      If you have stage III NSCLC and testing indicates that you are positive for ALK, ROS1, or RET fusions, Massive Bio can help you access cutting-edge treatments that are being studied in clinical trials. That includes experimental therapies and existing medicines that are being used in new ways. Patients who enroll in clinical trials receive innovative treatments and high-quality care under the direction of doctors, nurses, and other healthcare professionals who are participating in research to discover new therapies for cancer. Patients can gain access to promising drugs and new treatments long before they’re made available to the public. If you have ALK, ROS1, or RET fusion-positive NSCLC, we’re here to help. If you aren’t sure if you have a gene mutation linked to cancer, that’s okay. Additional testing can help you determine your exact diagnosis.

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      What is a Non-Small Cell Lung Cancer clinical trial?

      Clinical trials test the latest scientific advancements in Non-Small Cell Lung Cancer treatment. Patients who choose to enroll in trials can receive cutting-edge treatment and high-quality care under the direction of scientists, doctors, and researchers. Non-Small Cell Lung Cancer patients might gain access to promising drugs and innovative treatments long before they're made available to the public.

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      Dr. Arturo explains:
      What Are Clinical Trials?

      Cancer is an unfortunate reality that touches most of us at some point in our lives. If you or a loved one has cancer, you may have heard or read that clinical trials could offer access to innovative new treatments. But what exactly is a clinical trial? In this video, Massive Bio co-founder Arturo Loaiza-Bonilla, MD, explains how clinical trials work, what to expect if you enroll in one, and why a clinical trial can be an important treatment option for many cancer patients.




      ROS1 Positive Lung Cancer

      ROS1 positive lung cancer refers to cases of lung cancer in which the patient is positive for a mutation of the ROS1 gene. The ROS1 gene is responsible for making the protein ROS1, which signals cells to grow and reproduce. If a lung cancer patient is ROS1 positive, the cancer is usually more aggressive due to the ROS1 protein causing more abnormal cells to drive the growth of the tumor. However, ROS1 positive patients may be eligible for checkpoint inhibitors for treatment, which block the mutation from causing the cancerous cells to rapidly grow and divide. Although rare, the identification of the ROS1 alteration can play a major role in the patient’s treatment plan. Other than lung cancer, the ROS1 mutation has been identified in the following cancer types:


      -Glioblastoma multiforme

      -Bile duct cancer

      -Ovarian cancer

      -Colorectal cancer 


      Genetic Testing for ROS1

      ROS1-positive lung cancer has only been identified in non-small cell lung cancer (NSCLC), and not in small cell lung cancer. Of NSCLC cases, about 2% of them are ROS1 positive. This has led to an increase in testing for NSCLC patients.


      In order to be eligible for targeted therapies, cancer patients need a positive test for the ROS1 mutation. Typically, a tissue sample of the tumor is collected by the doctor and it is sent to a laboratory for results. The tests used for the ROS1 mutation include:


      -Fluorescence in situ hybridization (FISH): The most common testing method used, locates specific DNA sequences by exposing chromosomes to a probe with a fluorescent molecule attached. A researcher will be able to identify if the ROS1 gene if the fluorescent probe has been bound to it.

      -Multiplex real-time PCR assays: Test that covers a range of fusion genes. Inexpensive and quick results compared to other tests. This test uses multiple probes that can be distinguished from the rest of the DNA sequences.

      -Immunohistochemistry: Uses antibodies against the ROS1 protein to detect any abnormalities. This test is for screening to diagnose cancers, so it can be used initially to avoid unnecessary FISH tests.

      -Next Generation Sequencing (NGS): Looks at the entire human genome in one test to detect any mutation. NGS is the most comprehensive test available, but may be expensive and time consuming compared to other testing methods.



      ROS1 Positive Lung Cancer Clinical Trials


      The only FDA approved treatments for ROS1 positive lung cancer are Crizotinib (Xalkori) and entrectinib (Rozlytrek). These targeted therapies can locate the abnormalities within cells (mutations) to know which cells to attack. This helps treatment avoid damaging healthy cells to minimize side effects compared to standard treatments.

      Common side effects of ROS1 inhibitors include:






      -Changes in vision


      There are also ongoing clinical trials evaluating new therapies for ROS1 cancers. There are both clinical trials specifically for the ROS1 mutation, and many others available to treat lung cancer. Talk with your doctor to see if clinical trials could benefit you. Other drugs available for ROS1 lung cancer cases include Lorlatinib and Ceritinib. These therapies are often taken by themselves or in combination with chemotherapy and other treatments.



      ALK Fusion Clinical Trials

      Anaplastic lymphoma kinase (ALK) fusion is a genetic mutation in the ALK gene that is responsible for making a protein called ALK receptor tyrosine kinase. An ALK fusion is when the rearrangement of the gene EML4 and ALK fuse together, creating an oncogene EML4-ALK. ALK fusions can be a predictive biomarker for the effective use of certain targeted drug therapies, so it is important for patients to know if they have an ALK fusion. Patients without an ALK fusion will likely not respond to targeted ALK inhibitor drug therapies. ALK fusion clinical trials study the ALK inhibiting drugs that are available to treat patients who have this gene alteration.

      ALK fusion clinical trials commonly target to treat malignant solid tumors, which are cancerous tumors that do not contain cysts or liquid area. Examples of solid tumors include:






      ALK fusion clinical trials are currently studying ALK inhibitor drug therapies. An ALK inhibiting drug inhibits proteins involved in the abnormal growth of tumor cells, which is why these drugs are more effective for patients with this gene alteration. Drug therapies being studied in clinical trials include:













      Testing for ALK Fusion

      Cancer patients will be tested for ALK fusions if their doctor performs Next Generation Sequencing (NGS) to see if they would respond successfully to an ALK inhibitor drug therapy. Genetic testing for cancer patients can be beneficial, as there are many targeted drug therapies for biomarkers other than ALK fusions. Testing for ALK fusions usually coincides with testing for other gene mutations, such as ROS1 and EFGR mutations in non-small cell lung cancer. There are a few methods that are used to test for ALK mutations:


      -Next generation sequencing (NGS): detects ALK fusions and the fusion partner gene

      -Fluorescent in situ hybridization (FISH): looks for gene rearrangement, and is a common test used to look for ALK fusion

      -Immunohistochemistry (IHC): detects the altered ALK protein

      -Polymerase chain reaction (PCR): detects known ALK fusions, but not new fusions


      Non-Small Cell Lung Cancer Genomic Testing

      Non-Small Cell Lung Cancer Genomic Testing helps cancer patients determine which mutations they have inherited that will affect their prognosis.

      Non-Small Cell Lung Cancer Genomic Testing expresses the genes displayed by a cancer tumor. Any of these genes may have been mutated. Mutated gene structures help doctors gain insight into tumor behavior and propensity to spread.


      What is Non-Small Cell Lung Cancer Genomic Test?

      Genomic testing is used to detect changes in the DNA of cancer patients and tumors. Better targeted cancer treatment can be planned, including personalized treatments with the help of genomic tests.

      Genetic testing is now an important part of diagnosing and staging patients with non-small cell lung cancer. Some chemotherapy drugs may be more or less effective than others against tumors with certain mutations. Molecular analysis of the tumor helps determine which treatments will benefit the patient the most.

      Almost all of the genetic changes in cells are found only in cancer cells, not normal cells. This indicates that it is not possible to pass it on to your children.


      Non-Small Cell Lung Cancer Genetic Markers

      Currently, genomic abnormalities that are clinically actionable with FDA-approved drugs include changes in EGFR, ALK, ROS1, MET, RET, NTRK1 / 2/3 and BRAF genes. Most of these mutations occur during a patient’s lifetime and only occur in cancer cells.

      ALK Fusions:

      ALK fusions are seen in younger patients, nonsmokers or light smokers. When the ALK gene combines with another gene, EML4, it can trigger the development of lung cancer. ALK fusions are typically not found in patients with EGFR mutations.

      ROS1 Fusions:

      ROS1 fusions are usually identified in young nonsmokers. ROS1 can combine with many other genes to create an oncogenic fusion that can lead to lung cancer.

      RET Fusions:

      Similar to the ALK and ROS1 fusions in lung adenocarcinoma, RET fusions can initiate and sustain the tumor.



      ALK gene: MedlinePlus Genetics

      ALK Fusion – My Cancer Genome

      ALK Mutation (Gene Rearrangement) | Lab Tests Online

      Definition of solid tumor – NCI Dictionary of Cancer Terms – National Cancer Institute

      What is ALK-positive lung cancer? By the ALK Positive Community — ALK POSITIVE