Common Questions

Clinical studies help determine if study drugs, treatments, or devices are safe and if they produce the desired results for treating, preventing, or diagnosing a disease or other health condition. Regulatory authorities, like the Food & Drug Administration (FDA), require that clinical studies be done before a drug or device is approved and made available to the general public.

Federal law requires most health insurance plans to cover routine patient care costs in clinical studies under certain conditions, provided that:

• You are eligible for the study
• The study must be approved by a licensed Institutional Review Board (IRB)
• The study does not involve out-of-network doctors or hospitals if out-of-network care is not part of your plan

You, your doctor, or a member of the clinical study team should check with your health plan to find out which costs it will cover.

Clinical studies follow a specific set of standards and are closely regulated to help protect study participants. An Independent Ethics Committee (IEC) or Institutional Review Board (IRB) reviews and monitors each study closely to safeguard the rights and welfare of participants. Any known risks and side effects will be discussed during the informed consent process, but there may be unknown risks. It is important to understand that the investigational study drug being tested may not work for you, and that your condition or health could remain the same, improve, or get worse.

The use of placebo in oncology clinical studies is now very rare. Many studies compare the investigational study drug against the standard of care treatment for the disease to tell which one is better and safer for patients.

In the studies referenced on this website, there is no placebo group, and all study participants will receive the investigational study drug, tarlatamab, by infusion in a vein. The dosage and timing of infusions may vary depending on the rules of the study.

Clinical studies are done in different steps, or phases.

• Phase 1 studies are conducted to evaluate the safety of an investigational study drug, which includes collecting information about side effects. Phase 1 studies also identify the dosages of the investigational study drug to be tested in future clinical studies
• Phase 2 studies evaluate how well the investigational study drug works and collect additional information about safety and side effects
• Phase 3 studies evaluate the investigational study drug in large groups of people to confirm how well it works, to monitor side effects, to compare it to standard of care treatments, and to collect information that will allow it to be used safely
• Phase 4 studies take place after a drug is approved for use. These studies provide additional information about the drug’s risks, benefits, and best use in clinical practice

Clinical studies rely on the participation of patient volunteers. If you decide to participate in a clinical study, you will be asked to:

• Follow instructions from the study doctor and staff
• Attend all scheduled study visits (whether at a study clinic or by phone) and complete all required activities
• Tell the study doctor or staff about any changes to your health, even if you think the changes are not important
• Tell all of your non-study doctors that you are participating in a clinical study so they can let your study doctor know about any important medical information that may affect your participation in the study

Remember that you may ask questions at any time and should expect a prompt answer from the study staff.

Activities can vary from visit to visit and may include the following:

• Receive study treatment
• Have discussions about how you are feeling and about medications you may be taking outside of the study
• Complete questionnaires that ask health-related questions about your daily life
• Get a health check-up, which might include measurement of your vital signs, blood and urine tests, scans (CTs/MRIs), and/or physical examinations

If you choose to participate in a clinical study, you are encouraged to communicate freely with the study doctor and staff throughout the study. If you have questions or concerns about any aspect of the study, you should feel comfortable discussing them with the study doctor at any time.

Yes, you may leave a clinical study at any time because participation is voluntary. If you choose to participate, you will need to follow instructions and complete study-related activities BUT you may stop at any time for any reason.

Yes, you can. You can visit any doctor necessary to meet your health needs during a study. You should tell other healthcare professionals you see that you are participating in a clinical study and always communicate openly with the study doctor regarding other care you receive.

There are two main types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). SCLC makes up about 15% of lung cancer cases.

SCLC is a fast-growing cancer that develops when a specific type of lung cell, called a neuroendocrine cell, grows out of control.

SCLC is usually diagnosed based on the results of a tumor biopsy.

Your primary source of information about your health, or any health condition or diagnosis, should always be your doctor or another healthcare professional.

SCLC Disease Education

NEPC is an aggressive type of cancer that develops in the prostate gland. Diagnosis of NEPC is usually based on a biopsy of the cancer. Biopsies are often performed in metastatic castrate-resistant prostate cancer (mCRPC) patients with aggressive disease and/or disease progression with low or non-rising PSA levels.

NEPC can sometimes be diagnosed from a blood sample by looking for genetic changes in the DNA from the cancer¹.

Your primary source of information about your health, or any health condition or diagnosis, should always be your doctor or another healthcare professional.

¹Beltran H, et al. Circulating tumor DNA profile recognizes transformation to castration-resistant neuroendocrine prostate cancer. Journal of Clinical Investigation 130(4): 1653-1668, 2020.

NEPC Disease Education