NRG-LU005

People who have small cell lung cancer that has not spread outside their chest (also called limited stage small cell lung cancer).

This study is trying to determine if the addition of the immunotherapy drug atezolizumab to standard chemoradiotherapy can improve the survival of patients with small cell lung cancer.

Typically, patients with limited-stage small cell lung cancer are treated with chemoradiotherapy followed by optional radiation treatment to the brain to prevent further spread of the cancer.

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.

Both the atezolizumab and chemoradiotherapy treatments 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 drug may be made.

It is not possible to know if the addition of atezolizumab to traditional treatment 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.

Everyone on the study will be randomly assigned to receive either standard chemoradiotherapy or the same chemoradiotherapy with the added study drug, atezolizumab. The treatment period may last up to one year and participants will be followed for an additional five years after the study treatment ends. During the first 2 years after treatment, your doctor will check you every 3 months. During year 3, they will check you every 6 months, then annually unless your doctor thinks you need to be seen sooner.

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 the immunotherapy drug (atezolizumab) will be provided by the National Cancer Institute at no cost, however the costs associated with administration of the drug will be determined by your insurance. You will not have to pay for hepatitis B/C testing, which is required if you have not been tested for hepatitis before entering the study. 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.

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”. 

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".

• 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