Clinical trial: NCT04173507
Section: Alternatives
Subsections: What Is The Usual Approach To My Lung Cancer?

The usual approach for patients who are not in a study is treatment with other cancer directed treatments such as chemotherapy and combinations of chemotherapy with drugs that target tumor blood vessels. Your doctor can explain which treatment may be best for you. These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer.
Clinical trial: NCT04173507
Section: Confidentiality
Subsections: Who Will See My Medical Information?|How Will Information About Me Be Kept Private?

Your privacy is very important to us. The study doctors will make every effort to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not identify who you are. Some of your health information, such as your response to cancer treatment, results of study  
 tests, and medicines you took, will be kept by the study sponsor in a central research database. However, your name and contact information will not be put in the database. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. There are organizations that may look at or receive copies of some of the information in your study records. Your health information in the research database also may be shared with these organizations. They must keep your information private, unless required by law to give it to another group. Some of these organizations are:
- The study sponsor, SWOG Cancer Research Network, and any company supporting the study now or in the future. This would include any organization helping the company with the study.  
- The National Cancer Institute Central Institutional Review Board (NCI CIRB) which is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The Food and Drug Administration (FDA) and the groups it works with to review research.  
- The National Cancer Institute (NCI) and the groups it works with to review research.  
- The NCI's National Clinical Trials Network and the groups it works with to conduct research.  
- Transmission of Imaging and Data (TRIAD) and Imaging and Radiation Oncology Core
(IROC)-Your medical images with clinical study data (e.g., the treatment Group you are assigned to, etc.) will be transferred using a computer program called TRIAD to IROC, a central imaging laboratory sponsored by the NCI and located at Ohio State University in Columbus, Ohio. Your medical images will be reviewed by physicians at this organization as part of the study analysis for this trial.  
In addition to storing data in the study database, data from studies that are publicly funded may also be shared broadly for future research with protections for your privacy. The goal of this data sharing is to make more research possible that may improve people's health. Your study records may be stored and shared for future use in public databases. However, your name and other personal information will not be used. Some types of future research may include looking at your information and information from other patients to see who had side effects across many studies or comparing new study data with older study data. However, right now we don't know what research may be done in the future using your information. This means that:
- You will not be asked if you agree to take part in the specific future research studies  
  
using your health information.  
- You and your study doctor will not be told when or what type of research will be done. - You will not get reports or other information about any research that is done using your information.  
There are laws that protect your genetic information. However, there is a risk that someone could get access to your genetic information and identify you by name. In some cases, employers could use your genetic information to decide whether to hire or fire you. The study doctors believe the risk of this happening is very small. However, the risk may increase in the future as people find new ways of tracing information. For more information about the laws that protect you, ask your study doctor.

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:
1. 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.  
2. 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.  
3. Your personal information will not be given to anyone unless it is required by law. 4. If research results are published, your name and other personal information will not be used.
Clinical trial: NCT04173507
Section: Participant Responsibilities
Subsections: What Are My Responsibilities In This Study?

If you choose to take part in this study you will need to:  
- Keep your study appointments.  
- Tell your doctor about:
o all medications and supplements you are taking o any side effects o any doctors' visits or hospital stays outside of this study o and if you have been or are currently in another research study.  
- Write down in your patient diary when you take the study drug talazoparib.
For women: Do not get pregnant or breastfeed while taking part in this study. You must continue to use your approved method of birth control during the study and for 7 months after last dose. Tell your study doctor right away if you think that you have become pregnant during the study or within 7 months after your last dose of study treatment. For men: Do not father a baby while taking part in this study. You must continue to use your approved method of birth control during the study and for 4 months after last dose. Do not donate sperm while taking part in this study and for 4 months after your last dose of study treatment. Tell your study doctor right away if you think that your partner has become pregnant during the study or within 4 months after your last dose of study treatment.
Clinical trial: NCT04173507
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks And Benefits Of Taking Part In This Study?|Risks|Benefits|What Risks Can I Expect From Taking Part In This Study? General Risks|Blood Draw Risks|Side Effect Risks|Drug Risks|Possible Side Effects Of Talazoparib (Table Version Date: October 24, 2020)|Rare, And Serious|Rare, And Serious|Special Precautions|Common, Some May Be Serious In 100 People Receiving Avelumab, More Than 20 And Up To 100 May Have: - Tiredness|Rare, And Serious|Rare, And Serious|Additional Drug Risks Drug Interactions|What Are The Costs Of Taking Part In This Study?|What Happens If I Am Injured Because I Took Part In This Study?|What Are The Risks In This Optional Sample Collection?|What Are The Benefits To Taking Part In This Optional Sample Collection?|Are There Any Costs Or Payments To This Optional Sample Collection?

There are both risks and benefits to taking part in this study. It is important for you to think carefully about these as you make your decision.

We want to make sure you know about a few key risks right now. We give you more information in the "What risks can I expect from taking part in this study?" section. If you choose to take part in this study, there is a risk that the study approach may not be as good as the usual approach for your cancer at shrinking or stabilizing your cancer. There is also a risk that you could have side effects from the study drugs. These side effects may be worse and may be different than you would get with the usual approach for your cancer.  
Some of the most common side effects that the study doctors know about are:
- Anemia
- Nausea
- Tiredness
- Bruising, bleeding
- Reaction during or following a drug infusion which may cause rash, low blood pressure
There may be some risks that the study doctors do not yet know about.

Recent scientific research indicates that the combination of talazoparib and avelumab has shrunk your type of cancer in a limited number of people and animals or in living human or living animal cells. However, it is not known that this combination will work in everyone with your cancer or help you live longer. This study may help the study doctors learn things that may help other people in the future.

If you choose to take part in this study, there is a risk that talazoparib and avelumab may not be as good as the usual approach for treating your cancer. You also may have the following discomforts:  
- Spend more time in the hospital or doctor's office.  
- Be asked sensitive or private questions about things you normally do not discuss.  
- May not be able to take part in future studies.
The drugs used in this study could be very harmful to an unborn or newborn baby. There may be some risks that doctors do not yet know about. It is very important that you check with your study doctor about what types of birth control or pregnancy prevention to use during the study and for 7 months after you have stopped taking talazoparib and avelumab. Do not donate sperm while taking part in this study and for 4 months after your last dose of study treatment.

Common side effects of a blood draw are a small amount of bleeding at the time of the blood draw, brief pain, and maybe a bruise.

The drugs (talazoparib and avelumab) used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will test your blood and let you know if changes occur that may affect your health. There is also a risk that you could have other side effects from the study drugs. Here are important things to know about side effects:  
1. The study doctors do not know who will or will not have side effects.  
 2. Some side effects may go away soon, some may last a long time, and some may never go away.  
3. Some side effects may make it hard for you to have children.
4. Some side effects may be mild. Other side effects may be very serious and even result in death.  
You can ask your study doctor questions about side effects at any time. Here are important ways to make side effects less of a problem:
- If you notice or feel anything different, tell your study doctor. He or she can check to see if it is a side effect.  
- Your study doctor will work with you to treat your side effects.  
- Your study doctor may adjust the study drugs to try to reduce side effects.

The tables below show the most common and most serious side effects doctors know about. Keep in mind that there might be other side effects doctors do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

| (Table Version Date: October 24, 2020) COMMON, SOME MAY BE SERIOUS In 100 people receiving talazoparib, more than 20 and up to 100 may have: - Anemia which may require blood transfusion - Diarrhea, nausea, vomiting - Tiredness - Bruising, bleeding - Headache   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
OCCASIONAL, SOME MAY BE SERIOUS  
In 100 people receiving talazoparib, from 4 to 20 may have:  
- Pain  
- Constipation, heartburn  
- Sores in the mouth which may cause difficulty swallowing  
- Fever  
- Infection, especially when white blood cell count is low  
- Loss of appetite  
- Dizziness

In 100 people receiving talazoparib, 3 or fewer may have:
- Cancer of bone marrow caused by chemotherapy - Damage to the bone marrow (irreversible) which may cause infection, bleeding, may require transfusions
- A new cancer resulting from treatment of earlier cancer

In 100 people receiving AVELUMAB, 3 or fewer may have:
Avelumab may cause your immune system to attack normal organs and cause side effects in many parts of the body. These problems may include but are not limited to:  
- Heart problems including inflammation and heart failure. Symptoms and signs of heart problem may include: Shortness of breath, swelling of the ankle and body
- Swelling and redness of the eye - Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine.  
Signs and symptoms of colitis may include: diarrhea or increase in bowel movements, blood in your stools or dark, tarry, sticky stools, severe belly pain or tenderness
- Liver problems (hepatitis) which can cause liver failure. Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes, severe nausea or vomiting; drowsiness; pain in the right upper belly
- A condition with high blood sugar (diabetes) which leads to tiredness, frequent urination or excessive thirst which may require treatment with insulin
- Problem of the nerves that can cause paralysis. Signs and symptoms may include:
numbness, tingling of hands and feet; weakness of the arms, legs and facial muscle movement
- Inflammation of the brain (meningitis/encephalitis), which may cause: headache, confusion, sleepiness, seizures, and stiff neck
- Kidney problems, including nephritis and kidney failure requiring dialysis. Signs of kidney problems may include: decrease in the amount of urine, blood in your urine, ankle swelling
- Lung problems (pneumonitis and pleural effusion). Symptoms may include: new or worsening cough, chest pain, shortness of breath

Side effects of avelumab may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when avelumab is used in combination with talazoparib. **Call or see your healthcare provider right away if you** develop any problems listed below or the symptoms get worse.

OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving AVELUMAB, from 4 to 20 may have:
- Anemia which may require blood transfusion
- Diarrhea, nausea, vomiting
- Chills, fever
- Flu-like symptoms including body aches - Infection - Reaction during or following a drug infusion which may cause fever, chills, rash, low blood pressure
- Bruising, bleeding
- Loss of appetite - Cough
- Dry skin
- Itching, acne, rash Avelumab may cause your immune system to attack normal organs and cause side effects in many parts of the body. These problems may include but are not limited to:
- Hormone gland problems (especially the thyroid, pituitary and adrenal glands, and  
  
pancreas). Signs and symptoms may include: headaches that will not go away or unusual headaches, extreme tiredness or changes in mood or behavior decreased sex drive; weight loss or weight gain; excessive thirst or urine; dizziness or fainting
- Damage to the pancreas which may cause belly pain and hospitalization
- Pain or swelling of the joints
- Problem of the muscle (myositis), which can cause muscle pain and severe muscle weakness sometimes with dark urine

In 100 people receiving talazoparib, 3 or fewer may have:
- Cancer of bone marrow caused by chemotherapy - Damage to the bone marrow (irreversible) which may cause infection, bleeding, may require transfusions
- A new cancer resulting from treatment of earlier cancer

In 100 people receiving AVELUMAB, 3 or fewer may have:
Avelumab may cause your immune system to attack normal organs and cause side effects in many parts of the body. These problems may include but are not limited to:  
- Heart problems including inflammation and heart failure. Symptoms and signs of heart problem may include: Shortness of breath, swelling of the ankle and body
- Swelling and redness of the eye - Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine.  
Signs and symptoms of colitis may include: diarrhea or increase in bowel movements, blood in your stools or dark, tarry, sticky stools, severe belly pain or tenderness
- Liver problems (hepatitis) which can cause liver failure. Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes, severe nausea or vomiting; drowsiness; pain in the right upper belly
- A condition with high blood sugar (diabetes) which leads to tiredness, frequent urination or excessive thirst which may require treatment with insulin
- Problem of the nerves that can cause paralysis. Signs and symptoms may include:
numbness, tingling of hands and feet; weakness of the arms, legs and facial muscle movement
- Inflammation of the brain (meningitis/encephalitis), which may cause: headache, confusion, sleepiness, seizures, and stiff neck
- Kidney problems, including nephritis and kidney failure requiring dialysis. Signs of kidney problems may include: decrease in the amount of urine, blood in your urine, ankle swelling
- Lung problems (pneumonitis and pleural effusion). Symptoms may include: new or worsening cough, chest pain, shortness of breath

Over the counter, herbal medicines and other prescribed drugs will be reviewed by the study team for potential drug interactions. Your doctor or a member of the study team will tell you if you need to stop, modify or change any of these medicines or drugs before you start taking talazoparib and avelumab. Any medications or substances that contain strong P-gp or BCRP inhibitors should be avoided while you are taking talazoparib. Caution should be used for coadministration of other P-gp inhibitors (e.g., amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, erythromycin, felodipine, lopinavir, quercetin), P-gp inducers (e.g., avasimibe, carbamazepine, phenytoin, St John's wort), or BCRP inhibitors (e.g., cyclosporine, eltrombopag, and gefitinib). Throughout your treatment, you should inform your doctor about any medication changes.  
 Do not receive any live attenuated vaccinations, such as shingles or influenza nasal spray, while you are taking part in this study. Rarely, there are problems getting enough supplies of the study drugs. If that happens, your doctor will talk with you about your options.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer. This includes:  
- the costs of tests, exams, procedures, and drugs that you get during the study to  
  
monitor your safety and prevent and treat side effects.  
- the costs of getting the talazoparib and avelumab ready and giving it to you.  
- your insurance co-pays and deductibles.
Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn't pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study. Ask your doctor or nurse for help finding the right person to talk to if you are unsure which costs will be billed to you or your insurance provider. You or your insurance provider will not have to pay for the study drugs talazoparib and avelumab, exams, tests, and procedures done for research purposes only or that are covered by the study. These include:  
- the study drugs talazoparib and avelumab. - the collection or testing of the circulating tumor DNA before you begin the study, on Cycle 3 Day 1, if your disease becomes worse, and when you stop study treatment
Taking part in this study may mean that you need to make more visits to the clinic or hospital than if you were getting the usual approach to treat your cancer. You may:  
- Have more travel costs.  
- Need to take more time off work.  
- Have other additional personal costs.
You will not be paid for taking part in this study. The research may lead to new tests, drugs, or other products for sale. If it does, you will not get any payment.

If you are injured as a result of taking part in this study and need medical treatment, please talk with your study doctor right away about your treatment options. The study sponsors will not pay for medical treatment for injury. Your insurance company may not be willing to pay for a studyrelated injury. Ask them if they will pay. If you do not have insurance, then you would need to pay for these medical costs. If you feel this injury was caused by medical error on the part of the study doctors or others involved in the study, you have the legal right to seek payment, even though you are in a study. Agreeing to take part in this study does not mean you give up these rights.

1. The most common risks related to drawing blood from your arm are brief pain and maybe a bruise.  
2. Generally, hospitals will keep some of your tissue. This tissue may be used to help treat cancer in the future. There is a small risk that when this tissue sample is submitted to the biobank for this optional sample collection, your tissue could be used up.  
3. Your medical and genetic information is unique to you. There is a risk that someone outside of the research study could get access to your study records or trace information in a database back to you. They could use that information in a way that could harm you. Researchers believe the chance that someone could access and misuse your information is very small. However, the risk may increase in the future as people find new ways of tracing information.  
4. In some cases, this information could be used to make it harder for you to get or keep a job and get or keep health insurance. There are laws against the misuse of genetic information, but they may not give full protection. For more information about the laws that protect you, ask your study doctor or visit: https://www.genome.gov/10002328/

You will not benefit from taking part. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

There are no costs to you or your insurance. You will not be paid for taking part in this study. The research may lead to new tests, drugs, or other products for sale. If it does, you will not get any payment.
Clinical trial: NCT04173507
Section: Procedures
Subsections: What Will Happen If I Decide To Take Part In This Study?|What Exams, Tests, And Procedures Are Involved In This Study?|What Is Involved In This Optional Sample Collection?

If you decide to take part in this study, you will get the study drugs talazoparib and avelumab, until your disease gets worse or the side effects become too severe. Talazoparib and avelumab are drugs that may increase the ability of your immune system to fight lung cancer. After you finish your study treatment, your doctor will continue to follow your condition for up to three years from the time you went on study and watch you for side effects. If your disease has not gotten worse, follow up visits will occur every 3 months. If your disease has gotten worse, follow up visits will occur every 6 months for 2 years, then at the end of the 3 years from the time you go on study. At the follow-up visits you will have a physical exam, blood tests, and scans. Your doctor may give you other tests or procedures if they think they are needed for the regular care of your disease. Should your disease worsen, you have the option to participate in a different treatment study. As  
 before, the new treatment study that you will be offered will depend on a combination of the results of the previous testing done on your tumor sample and the sub-studies available. If the tests show that your tumor has more than one biomarker that qualifies you for different treatment studies, the sub-study you will be offered to participate in will be chosen by chance (randomization). A treatment study may be available even if your tumor does not have any additional biomarkers being tested or if you were not eligible to participate in the other (randomly assigned) sub-studies.

Before you begin the study, your doctor will review the results of your exams, tests, and procedures. This helps your doctor decide if it is safe for you to take part in the study. If you join the study, you will have more exams, tests, and procedures to closely monitor your safety and health. Most of these are included in the usual care you would get even if you were not in a study. Listed below are exams, tests, and procedures that need to be done as part of this study to monitor your safety and health, but may not be included in the usual care. We will use them to carefully follow the effects of the study treatment, including preventing and managing side effects. These exams, tests, and procedures to monitor your safety and health include:
- A blood test to check thyroid function will be done every other cycles Some exams, tests, and procedures are a necessary part of the research study but would not be included in usual care. Listed below are procedures that will be done for research purposes only.  
- Blood Test (circulating tumor DNA) at up to four timepoints: before you begin the study,  
  
on Cycle 3 Day 1 prior to treatment, if your disease becomes worse, and when you stop study treatment. You will be required to have about 1.5 tablespoons of your blood collected for the circulating tumor DNA testing. Circulating tumor DNA is found in the bloodstream and refers to DNA that comes from cancerous cells and tumors. An attempt will be made to do this blood draw at the same time as other blood draws. There is a chance that you will have another stick to obtain the blood. This blood will be tested for DNA not normally found in cells but that is present in your blood because it has been released from the tumors in your body. The results of this blood test are for research purposes. You and your doctor will not receive the results of this blood test. The information collected will help the study doctors learn about tumor abnormalities that may play a role in tumor development.

If you agree to take part, here is what will happen next:
1. About 2 teaspoons of blood will be collected from a vein in your arm (at the same time as other study blood tests) before you begin treatment, on Cycles 2, 3, 4, and again if your cancer gets worse.  
2. Your samples will be stored in the biobank. There is no limit on the length of time we will keep your samples and research information. The samples will be kept until they are used for research or destroyed.  
3. Researchers can only get samples from the biobank after their research has been approved by experts. Researchers will not be given your name or contact information.  
4. Some of your genetic and health information may be placed in central databases for researchers to use. The databases will not include your name or contact information.
Clinical trial: NCT04173507
Section: Purpose of Research
Subsections: Overview And Key Information What Am I Being Asked To Do?|Why Is This Study Being Done?

We are asking you to take part in this research study because you have non-squamous non-small cell lung cancer. Your tumor sample has been found to have a mutation in the *STK11* gene, for which there is a treatment option. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

This study is being done to answer the following question: Can we increase the ability of your immune system to fight lung cancer and lower the chance of your lung cancer growing or spreading by using a combination of talazoparib and avelumab? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your non-squamous non-small cell lung cancer. The usual approach is defined as care most people get for their non-squamous non-small cell lung cancer.
Clinical trial: NCT04173507
Section: Voluntary Participation
Subsections: Taking Part In This Study Is Your Choice.|Optional Studies That You Can Choose To Take Part In|Optional Sample Collections For Known Laboratory Studies And/Or Storage For Possible Future Studies|My Signature Agreeing To Take Part In The Study

You can choose to take part, or you can choose not to take part in this study. You also can change your mind at any time. Whatever choice you make, you will not lose access to your medical care or give up any legal rights or benefits. This document has important information to help you make your choice. Take time to read it.  
 Talk to your doctor, family, or friends about the risks and benefits of taking part in the study. It's important that you have as much information as you need and that all your questions are answered. See the "Where can I get more information?" section for resources for more clinical trials and general cancer information.

This part of the consent form is about optional studies that you can choose to take part in. They are separate from the main study described above. These optional studies will not benefit your health. The researchers leading these optional studies hope the results will help other people with cancer in the future. The results will not be added to your medical records and you or your study doctor will not know the results. Taking part in these optional studies is your choice. You can still take part in the main study even if you say "no" to any or all of these studies. There is no penalty for saying "no." You and your insurance company will not be billed for these optional studies. If you sign up for, but cannot complete any of these studies for any reason, you can still take part in the main study. Circle your choice of "yes" or "no" for each of the following studies.

Researchers are trying to learn more about cancer and other health problems using blood and tissue samples from people who take part in clinical trials. By studying these samples, researchers hope to find new ways to prevent, detect, treat, or cure diseases.  
Some of these studies may be about how genes affect health and disease. Other studies may look at how genes affect a person's response to treatment. Genes carry information about traits that are found in you and your family. Examples of traits are the color of your eyes, having curly or straight hair, and certain health conditions that are passed down in families. Some of the studies may lead to new products, such as drugs or tests for diseases.

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed and dated copy of this form. I agree to take part in the main study. I also agree to take part in any additional studies where I circled "yes". Participant's signature **(or legally authorized representative)** Date of signature ______________________________________________________________ Signature of person(s) conducting the informed consent discussion Date of signature ______________________________________________________________
Clinical trial: NCT04173507
Section: Withdrawal from Study
Subsections: What Are My Choices If I Decide Not To Take Part In This Study?|If I Decide To Take Part In This Study, Can I Stop Later?|Are There Other Reasons Why I Might Stop Being In The Study?|What If I Change My Mind About This Optional Sample Collection?

- You may choose to have the usual approach described above. - You may choose to take part in a different research study, if one is available.  
- You may choose not to be treated for cancer.  
- You may choose to only get comfort care to help relieve your symptoms and not get treated for your cancer.

Yes, you can decide to stop taking part in the study at any time.  
 If you decide to stop, let your study doctor know as soon as possible. It's important that you stop safely. This may mean slowly stopping the study drugs so that there is not a sudden, unsafe change or risk to your health. If you stop, you can decide if you want to keep letting the study doctor know how you are doing. Your study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

Yes. The study doctor may take you off the study if:
- Your health changes and the study is no longer in your best interest.  
- New information becomes available and the study is no longer in your best interest.  
- You do not follow the study rules.  
- You become pregnant while on the study. - The study is stopped by the National Cancer Institute (NCI), Institutional Review Board
(IRB), Food and Drug Administration (FDA), or study sponsor (SWOG Cancer Research Network). The study sponsor is the organization who oversees the study.  
It is important that you understand the information in the informed consent before making your decision. Please read, or have someone read to you, the rest of this document. If there is anything you don't understand, be sure to ask your study doctor or nurse.

If you decide you no longer want your samples to be used, you can call the study doctor, ______________________ *(insert name of study doctor for main trial)* at __________________ (insert telephone number of study doctor for main trial), who will let the biobank know. Then, any sample that remains in the biobank will be destroyed or returned to your study doctor. This will not apply to any samples or related health information that have already been given to or used by researchers.