����ֱ��

You are being invited to participate in a research study. Research studies answer important questions that might help change or improve the way we do things in the future.

This consent (permission) form will give you information about the study to help you decide whether you want to participate. Please read this form, and ask any questions you have, before agreeing to be in the study.

Taking part in this research study is voluntary. You do not have to participate in this study and may choose to leave the study at any time. If you decide not to participate in this study or leave the study at a later time, your health care, benefits, or relationship with ����ֱ�� will not change or be affected.

The purpose of this study is to compare the effects, good or bad, of divarasib versus sotorasib or adagrasib on participants with lung cancer that has the KRAS G12C mutation. In this study, you will get either divarasib, or sotorasib or adagrasib.

Divarasib is an investigational drug, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied. In this study, divarasib is being studied for the treatment of lung cancer.

If you agree to participate in this study, your participation may last more than 4 years, depending on how your lung cancer responds to treatment. You will be asked to provide a tumor tissue sample (biopsy) and have tissue tested for KRAS G12C to be eligible for the study. You will be asked to complete 4 visits during the first 6 weeks and 1 visit every 3 weeks thereafter while you are receiving treatment. Visits may last anywhere from 1-6 hours.

During these visits, you will be asked to provide a blood and urine sample. There will be scans like computed tomography (CT), magnetic resonance imaging (MRI) scan, and a bone scan. You will also be asked to provide medical history, medications taken, and demographic information along with a physical examination and vital signs. You will also answer questionnaires about your disease. For a detailed description of study procedures, please see the “What are the activities you will be doing if you participate in this study?” section of this consent form.

There are risks to you for participating in this study, some of which may be serious, may cause death, or may not go away. In this study, there is a risk of diarrhea, nausea, and vomiting. Additional risks also include abdominal pain, lack of red blood cells (anemia), back pain and constipation. Side effects can be mild to severe and even life threatening, and they can differ from person to person. For a detailed list of risks you should know about, please see the “What are the risks and discomforts of participating in this study?” section of this consent form.

You may not directly benefit from taking part in this study, but we hope that knowledge gained from this study may benefit others with non-small cell lung cancer in the future.

You should not expect your condition to improve as a result of participating in this study.

Instead of taking part in this study, you may choose to get treatment for your lung cancer without being in this study (standard therapy would be sotorasib or adagrasib), join a different study, get no treatment, or get comfort care (also called “palliative care”). You should discuss these other options with your study doctor.

In order to participate you must meet the following criteria:

• Have been clearly diagnosed (under a microscope) with a type of advanced lung cancer (non-small cell lung cancer) that can't be treated with surgery or a combination of chemotherapy and radiation.
• Have cancer that has gotten worse during or after trying at least one, but no more than three, previous drug treatments for advanced or spread cancer.
• Have tumors that can be measured using standard medical guidelines for tracking tumor size.
• Have had tests show that their cancer has a specific genetic mutation called KRAS G12C.

You will be excluded from the study if any of the following criteria apply to you:

• Have a known allergy to any ingredient in the drugs divarasib, sotorasib, or adagrasib.
• Have a condition (like malabsorption syndrome) that makes it hard for their body to absorb medicine through the digestive system.
• Have another known genetic mutation in their cancer that can also cause it to grow (a second "driver" mutation).
• Have lung cancer that is a mix of types, including small-cell lung cancer or a rare type called large cell neuroendocrine carcinoma.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.