Clinical trial: NCT06062810
Section: Alternatives
Subsections: What Is The Usual Approach To My Non-Small Cell Lung **Cancer?**|What Are My Other Choices **If I Do Not Take Part In This Study?**

You are being asked to take part in this research study because you have had lung tissue biopsy for your non-small cell lung cancer. People who are not in a research study may be treated with chemotherapy drugs after lung tissue biopsy. There are two FDA-approved drugs XALKORI -
crizotinib capsule plus GILOTRIF - afatinib tablet, film coated) that are commonly used. For patients who receive the usual approach for this cancer about 70 out of 100 may be alive and free of cancer in one year.

If you decide not to take part in this study, you have other choices. For example:
- you may choose to have the usual approach described above …
- you may choose to take part in a different study if one is available …
- or you could decide not to be treated for cancer …
Clinical trial: NCT06062810
Section: Confidentiality
Subsections: Who Will See My Medical Information?|How Will Information About Me Be Kept Private?

Your privacy is very important to us, and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database.  
There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:  
- The Medicine Invention Design, Inc. and other drug companies supporting this study. - The Institutional Review Board, IRB, 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 in the U.S. and similar agencies in other countries involved in the study.

Your privacy is very important to the researchers, and they will make every effort to protect it. Here are just a few of the steps they will take: 1) When your sample is sent to the researchers, no information identifying you (such as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and MIDINC Clinical Research Multiple Group staff with access to the list must sign an agreement to keep your identity confidential.  
3) Researchers to whom the MIDINC Clinical Research Multiple Group sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
4) Information that identifies you will not be given to anyone, unless required by law. 5) If research results are published, your name and other personal information will not be used.
Clinical trial: NCT06062810
Section: Duration of Study Involvement
Subsections: How Long Will I Be In **This Study?**

You will receive the study drugs for six months if you are in Group 1 and in Group 2. After you finish the study drugs, you will be asked to see your study doctor for follow-up examinations for 2 years. Your study doctor would like to continue to watch you for side effects and follow your condition for the rest of your life.
Clinical trial: NCT06062810
Section: Participant's Rights
Subsections: What Are My Rights In This Study?

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the Medicine Invention Design, Inc. Institutional Review Board (IRB) at 1-301-222-7143.
Clinical trial: NCT06062810
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Possible Risks Can I Expect From Taking Part **In This Study?**|What Possible Benefits Can I Expect From Taking Part In This **Study?**|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Are **The Possible Risks?**|What Are The Possible Benefits?

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. - The usual chemotherapy drugs may not be better, and could be possibly worse, than receiving the chemotherapy drugs.
The study drugs 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 be testing your blood, urine, and tissue, and will let you know if changes occur that may affect your health. There is also a risk that you could have side effects from the usual chemotherapy drugs and the study chemotherapy drugs.  
Here are important points about side effects:  
- The study doctors do not know who will or will not have side effects. - Some side effects may go away soon, some may last a long time, or some may never go away. - Some side effects may interfere with your ability to have children.  
- Some side effects may be serious and may even result in death.  
Here are important points about how you and the study doctor can make side effects less of a problem:
- Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.  
- The study doctor may be able to treat some side effects.  
- The study doctor may adjust the study drugs to try to reduce side effects.
The tables below show the most common and the most serious side effects that researchers know about. There might be other side effects that researchers do not yet know about. If important new side effects are found, the study doctor will discuss these with you. Study Group 1 and Group 2 - Possible Side Effects of the usual chemotherapy and the study chemotherapy for this type of cancer:

It is not possible to know at this time if the study chemotherapy is better than the usual chemotherapy, so this study may or may not help you. This study will help researchers learn things that will help people in the future.  
The classic oncology drug clinical trials must have placebo group, but the cancer patients in the placebo group will be equivalent to giving up oncology drug treatments, so the placebo group cancer patients will surely die. But, because every SNP has biallelic alleles ALL-OR-NONE characteristics, in same one SNP clinical trial, toward same one therapeutic effect or same one side effect, all two of double-blind random separate group patient drug target gene SNPs will be the same.  
Therefore, only need set up two double-blind random separate groups of patients, and then treat same one cancer with two different combination chemotherapies including same oncology drugs separately in two different treating groups; in these SNP-pharmacogenomics clinical trials, the placebo group will surely be avoided. Like this, even in the SNP clinical trial stage, also can rescue much many cancer patients' lives. This clinical project's success means that the cancer organ system limitation of oncology drug chemotherapy will be broken-through, meanwhile, the cancer patient population who can use specific one oncology drug will be expanded. Because based on SNP biallelic alleles ALL-OR-NONE characteristics, if the same Oncology Drug Therapeutic Effect Target Gene SNP is detected in different cancers, when using the same drug, any kinds of cancers having the same drug therapeutic effect target gene SNP will have same therapeutic effect; so, any kinds of cancers having the same drug therapeutic effect target gene SNP will be suitable for using the same drug to treat.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive some help for this even though you are in a study.

1) There is a risk that someone could get access to the personal information in your medical records or other information the researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small but cannot promise that they will not occur.

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.
Clinical trial: NCT06062810
Section: Procedures
Subsections: What Extra Tests Will I Have If I Take Part In This Study?|What Is Involved?

If you are assigned to Group 1, all of the tests you will have are part of the usual approach for your cancer. If you are assigned to Group 2, all of the tests you will have are part of the study approach for your cancer. There are blood, urine, and tissue tests that you will need to have:
- Sequence precisely each target gene DNA whole chain in cancer tissue like as following:
ALK, EGFR.  
- Correlate ALK Gene Single Nucleotide Polymorphisms (SNPs) to Using Crizotinib Therapeutic Effects of Treating Non-Small Cell Lung Cancer (NSCLC), based on precisely sequencing drug target gene via Cancer Tissue DNA.  
- Sequence precisely each target gene DNA whole chain in peripheral blood like as following:
CYP3A4.  
- Correlate CYP3A4 Gene Single Nucleotide Polymorphisms (SNPs) to Using Crizotinib Side Effects of Treating Non-Small Cell Lung Cancer (NSCLC), based on precisely sequencing drug target gene via Peripheral Blood DNA.  
- You will need lung tissue biopsy test at least one time. - You will need an image test at least one time per month. - If you have an allergic reaction to oncology drugs, you will have an extra blood test. - You will need urine tests every week while you are taking oncology drugs. - You will need blood tests every week while you are taking oncology drugs.  
Your insurance company will be charged for the blood, urine, and tissue biopsy tests related to oncology drugs.

If you agree to take part, here is what will happen next: 1) A sample from the tissue that was collected at the time of your biopsy will be sent to the Biobank.  
2) Your sample and some related information may be stored in the Biobank along with samples and information from other people who take part. The samples will be kept until they are used up.  
3) Qualified researchers can submit a request to use the materials stored in the Biobank. A
science committee at the clinical trials organization, and/or the MIDI, will review each request. There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you.  
4) Neither you nor your study doctor will be notified when research will be conducted or given reports or other information about any research that is done using your samples.  
5) Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.
Clinical trial: NCT06062810
Section: Purpose of Research
Subsections: Phase 2 **Oncology Snp Study Consent Form** Study Title For Study Participants:|Why Is This Study Being Done?

Testing the SNPs **of the study chemotherapy, comparing to the SNPs of**
the usual chemotherapy in non-small cell lung cancer Pharmacogenomics IND EXEMPT SNP Clinical Study - Crizotinib **Capsule**
and Single Nucleotide Polymorphisms (Drugs-SNPs)

The purpose of this study is to test any good and bad effects of the study chemotherapy low dose drugs (XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated) compared to the usual chemotherapy high dose drugs (XALKORI - crizotinib capsule plus GILOTRIF - afatinib tablet, film coated). The study group drugs could cause therapeutic effects of chemotherapy by preventing your cancer from returning or they could cause side effects or reduce the benefits of chemotherapy. This study will allow the researchers to know whether the study chemotherapy drugs are better, the same or worse than not doing so. Correlate oncology drugs' targets' genes' single nucleotide polymorphisms (SNPs) to using oncology drugs therapeutic effects and side effects of treating non-small cell lung cancer (NSCLC), based on precisely sequencing oncology drugs' targets' genes. The chemotherapy efficacy can arrive higher than the 90% Effective Dose (ED90) level. The chemotherapy risk can be lower than the 10% Lethal Dose (LD10) level. There will be about 600 people taking part in this study.
Clinical trial: NCT06062810
Section: Voluntary Participation
Subsections: Additional Studies Section: This Section Is About An Optional Study **You Can Choose To Take Part In**|Optional Sample Collections For Biobanking For Possible Future Studies|My Signature **Agreeing To Take Part In The Main Study**

You can still take part in the main study even if you say 'no' to this study. If you sign up for but cannot complete this study for any reason, you can still take part in the main study.

Researchers are trying to learn more about cancer, diabetes, and other health problems. Much of this research is done using samples from your tissue, blood, urine, or other fluids. Through these studies, researchers hope to find new ways to prevent, detect, treat, or cure health problems.  
Some of these studies may be about genes. Genes carry information about features that are found in you and in people who are related to you. Researchers are interested in the way that genes affect how your body responds to treatment. The researchers ask your permission to store and use your samples and health information for medical research. The research that may be done is unknown at this time. Storing samples for future studies is called 'biobanking'. The Biobank is being run by the MIDINC Clinical Research Multiple Group and supported by the Medicine Invention Design, Inc. (MIDI).

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 copy of this form. I agree to take part in the main study and in the optional study if I have circled "Yes". Participant's signature _________________________________________ Date of signature_____________________________________ Study Doctor's signature_________________________________________ Date of signature_____________________________________ Study Nurse / Assistant's signature_________________________________________ Date of signature_____________________________________
Clinical trial: NCT06062810
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part **In This Study?**|What If I Change My Mind?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The 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. The study doctor may take you out of the study:  
- If your health changes and the study is no longer in your best interest - If new information becomes available - If you do not follow the study rules - If the study is stopped by the sponsor, IRB, or FDA

If you decide you no longer want your samples to be used, you can call the study doctor via 1301-222-7143 who will let the researchers know. Then, any sample that remains in the bank will no longer be used. Samples or related information that have already been given to or used by researchers will not be returned.