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About This Study

NRG-LU003 is a National Cancer Institute and NRG Oncology clinical trial to study clinical benefit of 2nd or 3rd generation ALK inhibitor in patients who develop progression on a second-generation ALK inhibitor. Treatment will be based on genetic changes identified on their tumor biopsy. NRG-LU003 will be comparing a number of ALK inhibitors including lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib. These targeted therapies may stop the growth of tumor cells by blocking some of the enzymes needed for cancer growth. NRG-LU003 will also be comparing the chemotherapy drugs pemetrexed plus cisplatin, and or carboplatin to test if chemotherapy may work equal, better or worse in these patients. More specific details about the treatment can be found in the FAQ section below.

More information about this particular study is located on

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Additional information for the NRG Oncology LU003 trial can be found in the Patient Study Brochure

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Am I eligible for this study?

Your healthcare team is the best source for information about your treatment options, including the ability to help you make decision to participate in cancer clinical trials. Be sure to take the information you find to your doctor for discussion about possible studies and for questions and concerns.

Are there other studies I might be eligible for?

Please talk to your healthcare team to see if there are other clinical studies that you may be a good fit for. Click here if you would like to view a more detailed chart of other studies available.

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Frequently Asked Questions

Below, you can find FAQs about clinical research and this particular clinical trial.


People with non-small cell lung cancer whose lung cancer has a change in the gene called “ALK”. Study participants will have to have received treatment with an ALK-targeting drug for your ALK positive lung cancer and will have to no longer be responding to that treatment.
This study is trying to determine if there is a better or optimal treatment for patients with ALK positive non-small cell lung cancer. This is, in part, based on gene resistance changes found on cancer biopsy results. 
Typically, patients with ALK positive lung cancer who are no longer responding to an ALK targeting drug are treated with a different ALK targeting drug or chemotherapy.
If you choose to take part in this study, there is a risk that:

  • You may lose time at work or home and spend more time in the hospital or doctor’s office than usual.
  • You may be asked sensitive or private questions which you normally do not discuss.

  • All biomarker/ALK inhibitors and chemotherapy used in this study may cause side effects. Your doctor will review all of the potential side effects with you before treatment starts. You are encouraged to tell your doctor about any side effects during the study so that they may be treated and so that potential adjustments to the study drugs may be made. 
    It is not possible to know if the study drugs/study approach is better than the usual approach, so this study may or may not help you.  Regardless, this study will help researchers learn things that may help people in the future. Access to some of these medications available in this study may not be readily available outside of a clinical trial.
    There are two parts to this study: screening and treatment. If you decide to take part in this study, you will undergo a fresh tumor biopsy and blood sample will be collected. The treatment you receive will be based on the results of the testing done on the tissue and blood samples collected in the screening part of the study. During treatment, most treatment cycles repeat every 21 days then, after completion of the study treatment, patients are followed up for 30 days, every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
    No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. 
    You and/or your health plan/insurance company will need to pay for all of the costs of treating your cancer while in this study, but some of the targeted therapies may be provided. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. 

    You will not be paid for taking part in this study.
    If you decide not to take part in this study, your doctor will discuss other treatment options with you.
    Your privacy is very important to the study researchers and biobank. They will make every effort to protect it. Here are just a few of the steps they will take: 

  • They will remove identifiers, such as your initials, from your sample and information. 
  • They will replace them with a code number. There will be a master list linking the code numbers to names, but they will keep it separate from the samples and information. 
  • Researchers who study your sample and information will not know who you are. They also must agree that they will not try to find out who you are. 
  • Your personal information will not be given to anyone unless it is required by law.  
  • If research results are published, your name and other personal information will not be used.
  • Clinical Studies FAQ

    Doctors and researchers conduct a clinical study, also called a “clinical trial”, to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”. 

    Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.
    Yes. They are exactly the same thing.
    The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.
    A clinical study may take place in many locations, such as:

  • physician offices
  • hospitals
  • clinics

  • A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.
    No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials".

    If you decide not to take part in a clinical study, you still have other choices. Talk to your doctor about your other choices.For example:

    • You may choose to have the usual treatment approach (known as “standard of care”)
    • You may choose to take part or learn more about a different study, if one is available
    • You may choose not to be treated for cancer

    About NRG Oncology

    At NRG Oncology, we focus on conducting clinical studies aimed to improve current cancer care practices and the lives of cancer patients. NRG Oncology partners with more than 1,300 member sites world-wide to research ways to improve treatment standards in the cancer community. Our organization is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trial's Network.

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