Lung cancer clinical trials — also called research studies — are designed to find more effective treatments for lung cancer. Some people with lung cancer may decide to participate in a research study for the opportunity to try a new therapy. Others may wish to contribute to medical knowledge to help other people with lung cancer.

Lung cancer research is always ongoing because scientists and doctors are learning more and more about the disease every day. There are a wide variety of studies covering different kinds of lung cancer in different stages. Research is important for understanding whether new treatments or different ways of using existing treatments lead to better outcomes.

People feel differently about participating in clinical trials. One MyLungCancerTeam member seemed hesitant when they said, “Got word I probably qualify for a clinical trial. We’ll see what happens.”

Another was more excited and shared, “Trial drugs are out there and they work!”

Yet another added, “I am excited today! I got into a clinical trial which has shown great results.”

If you have lung cancer, you may be eligible for a new clinical trial. Even if you’re not currently thinking about participating in a study, it’s a good idea to learn the basics about how oncology research studies work.

1. Clinical Studies Test New Treatments and Advance Research

When you participate in a clinical trial, you may gain access to new treatments that are in development, new combinations of treatments, or existing treatments under review for new types of use. Some clinical trials don’t test new drugs at all and instead evaluate ways to improve cancer prevention, overall health, or survivorship.

The treatment being studied is called an investigational drug or therapy. For lung cancer, these often include new types of immunotherapy or therapies that target certain proteins on lung cancer cells. Every existing treatment has gone through a clinical trial, and some participants in those trials had early access to new therapies.

By joining a clinical trial, you can also help ensure that the study population includes people of your age, race, and ethnic background. Diverse study populations help scientists better understand how lung cancer treatments work among people across a variety of demographics.

Different clinical trials will have different goals. Overall, researchers want to treat lung cancer more effectively and raise the quality of life for people with the condition. Most research studies want to find answers to questions like these:

• Is a new medication safe and effective?
• What dosage of an existing or new medication works best?
• Is a new treatment better than existing treatments?
• Does a new treatment cause fewer side effects than existing treatments?
• Does a new treatment help people who haven’t responded to other treatment options?

2. You Will Be Informed if You Might Receive a Placebo

A placebo, sometimes called a “sugar pill,” is designed to look like the treatment being studied but doesn’t have any active ingredients. To test the effectiveness of an investigational treatment, clinical trials may assign a group of participants a placebo in order to compare results. In every clinical study, participants are informed if there is a chance they might receive a placebo instead of the treatment under study.

Placebos are rarely used alone in cancer clinical trials, because withholding treatment would be unethical. In most cancer studies, an investigational treatment is compared to an existing treatment. A placebo may be used without additional treatment in a cancer trial only if no effective treatment currently exists.

Some studies will use a placebo when they are testing a treatment that already exists combined with something new. A group of people participating in the trial can get a placebo alongside the current treatment. Another group would get the new treatment alongside the current one.

In most trials, the group that receives the investigational treatment versus the group that takes a placebo — or existing treatment — is decided randomly to avoid bias. This process is called “randomization.” Many research studies are also double-blind, meaning neither the trial participants nor the researchers know which participants are receiving which treatment until the trial is over.

If the treatment being evaluated seems to be significantly more effective than the existing treatment, all participants may have the option to switch to it during the course of the study. If having access to the treatment being studied if it works well is important to you, ask questions about how the study is designed before you join it.

3. Your Safety, Privacy, and Well-Being Will Be Protected

The safety of participants is a priority in clinical trials, and there are safeguards in place to protect you. These protections were carefully developed in response to historical wrongdoings in which individuals’ rights were not maintained in medical research.

In this day and age, clinical trials in the United States are overseen by the U.S. Food and Drug Administration (FDA), which is mandated by law to protect human safety. Other regulatory boards serve a similar function in countries around the world.

Institutional Review Board

In the United States, an ethical body called an Institutional Review Board (IRB) approves and monitors the majority of clinical trials. The IRB’s role is to protect the safety and rights of participants in clinical research studies. IRBs assess studies to ensure that the potential benefits of clinical trials are significantly greater than the risks and that appropriate precautions are in place to protect participants. If it is determined during the course of the trial that it is no longer safe to proceed, the study will be discontinued.

Informed Consent

Before joining a research study, you will be given thorough information about the goals of the trial and potential risks for participants. Clinical trials are required to help you make an educated decision about volunteering in a study. This process is called “informed consent.”

Every lung cancer treatment, even the standard ones, will come with the risk of side effects or reactions. Trials are designed carefully to make the risk level as low as possible. If you participate in a trial, you will undergo extra monitoring to make sure any benefits of the treatment outweigh the risks.

During the informed consent process, you will be able to ask as many questions as you want. You will also have time to talk to your medical provider, your family, and anyone else whose opinion you value. This ensures you are comfortable before you choose to participate in the trial.

You will also be given general information about the research study, such as how much time will be required, any costs, what kind of travel may be involved, and what the medical procedures of the trial involve. Costs for clinical trials are usually covered by the company or organization sponsoring the trial, along with health insurance.

Clinical trials happen in phases, often rendered with Roman numerals, such as “phase II” instead of “phase 2.”

• Phase 1 trials look at whether a drug is safe, how much of it people need, how it can most effectively be delivered, and what side effects are the most common.
• Phase 2 trials look at a treatment’s effectiveness and safety in treating one type of cancer.
• Phase 3 trials look at the effectiveness and safety of a treatment in comparison to other treatments.
• Phase 4 trials look at the long-term effectiveness and side effects of a treatment that has been approved.

4. Trials Focus on Different Types and Stages of Lung Cancer

A research study for lung cancer is likely to focus on a particular type of lung cancer, like non-small cell lung cancer (NSCLC), and stages of the disease, such as early stage lung cancer or metastatic lung cancer (lung cancer that has spread to other parts of the body). Each trial has specific criteria regarding who is eligible to participate. These criteria may include:

• A person’s age
• Their disease stage
• Types of treatment they’ve had
• How they’ve responded to other treatments

Some studies may be focused on lung cancer that involves cancer cells with specific genetic mutations.

5. You Can Leave a Lung Cancer Research Study at Any Time

Anyone who participates in a clinical trial is a volunteer. This means you always have the right to quit the study, or withdraw from it, anytime you want to, for any reason. You do not have to complete the study if you don’t want to. You will sign documents when you begin a study, but these are not the same as a contract.

If you decide to leave a clinical study, let the research staff know so you can be formally withdrawn. Depending on the trial, you may need to undergo monitoring when discontinuing study treatment. If you are considering withdrawing, reach out to the study team or your doctor first, so you can discuss questions or concerns.

6. Most People Still See Their Regular Doctor During a Trial

If you participate in a lung cancer study, you will usually need to go to a clinical or research facility for that treatment. This can be a specific hospital, a university medical facility, or another designated location. You will also need to have follow-up visits and monitoring done, which will also take place at the study’s cancer center. Most of the time, you will also see your regular doctor in addition to these visits.

The medical care you receive as part of the trial doesn’t replace comprehensive health care. Your doctors can coordinate with the research team to help ensure that the clinical trial treatment is compatible with any other treatments you are taking. Your oncologist can help you understand how participating in a research study might affect your care.

You can ask your doctor about clinical trials for which you may be eligible, or search for studies at ClinicalTrials.gov.

Talk With Others Who Understand

On MyLungCancerTeam — the social network for people with lung cancer and their loved ones — more than 12,000 members come together to ask questions, give advice, and share their stories with others who understand life with lung cancer.

Are you considering participating in a clinical trial to treat lung cancer? Share your experience in the comments below, or start a conversation by posting on your Activities page.