Clinical trials help determine if clinical trial 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 trials 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 trials under certain conditions, provided that:

• You are eligible for the clinical trial.
• The clinical trial must be approved by a licensed Institutional Review Board (IRB).
• The clinical trial 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 trial team should check with your health plan to find out which costs it will cover.

Clinical trials follow a specific set of standards and are closely regulated to help protect participants. An Independent Ethics Committee (IEC) or Institutional Review Board (IRB) reviews and monitors each trial 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 drug being tested may not work for you, and that your condition or health could remain the same, improve, or get worse.

A placebo is an inactive substance that does not include any medicine. It is used when testing new drugs and there is no standard treatment available.

Clinical trials are done in different steps, or phases.

• Phase 1 clinical trials are conducted to evaluate the safety of an investigational drug, which includes collecting information about side effects. Phase 1 clinical trials also identify the dosages of the investigational drug to be tested in future clinical trials.
• Phase 2 clinical trials evaluate how well the investigational drug works and collect additional information about safety and side effects.
• Phase 3 clinical trials evaluate the investigational trial 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 clinical trials take place after a drug is approved for use. These trials provide additional information about the drug’s risks, benefits, and best use in clinical practice.

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

• Follow instructions from the clinical trial doctor and staff.
• Attend all scheduled trial visits (at the clinical trial location or by phone) and complete all required activities.
• Tell your doctor or their staff about any changes to your health, even if you think the changes are not important since it may affect your participation in the clinical trial.

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

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

• Receive the investigational drug or other treatment that may be part of the clinical trial.
• Have discussions about how you are feeling and about medications you may be taking outside of the trial.
• 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 trial, you are encouraged to communicate freely with your doctor and their staff throughout the trial. If you have any questions or concerns, you should feel comfortable discussing them with your doctor or their staff at any time.

Yes, you may leave a clinical trial at any time because participation is voluntary. If you choose to participate, you will need to follow instructions and complete trial-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 clinical trial. You should tell other healthcare professionals you see that you are participating in a clinical trial and always communicate openly with your 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.

Your doctor will help you understand the SCLC stage. In general, limited-stage SCLC may be limited to one lung, while extensive-stage has spread to a second lung or other organs.

Each DeLLphi trial has specific eligibility criteria that are based on the stage of your SCLC and what you have been treated with so far. Talk to your doctor or contact an Amgen Medical Information Healthcare Professional if you have additional questions.