Enrollment Steps for Lung Cancer Clinical Trials

Whether you’ve just been diagnosed with cancer or it has come back after treatment rounds, you may wonder if enrolling in a lung cancer clinical trial might be a good treatment option for you.

A clinical trial aims to find new ways to prevent, diagnose, or treat disease. It may involve comparing new treatments or combinations of treatments to standard care for cancer. Specifically, lung cancer clinical trials test new treatments to see if they are safe, effective, and better than current standard treatments.

Lung cancers are abnormal growths (also called tumors) that develop in the lung and can spread to other tissues and organs. These tumors can interfere with your breathing or the healthy functioning of your other organs if they spread. Eventually, cancer can be deadly.

Cancer can develop from many different lung cells, but the most common lung cancers are small cell lung cancer and non-small cell lung cancer. 

Lung cancer is treated with combinations of surgery, chemotherapy, radiation, targeted treatments, and immunotherapy to remove cancerous cells and stop them from spreading to other organs. Your healthcare provider will create a treatment plan depending on the type of cancer you have, its cellular and genetic characteristics, and how advanced it is. 

These treatment plans are created based on standard therapy recommendations from medical groups. These standard treatments are tested to ensure they’re the most effective for reaching your treatment goals. Clinical trials are part of the process that new therapies go through to become “standard” treatments. 

This article will walk you through who is eligible for cancer clinical trials, the benefits of clinical trials, and the process of enrolling in clinical trials for lung cancer.

Reasons to Participate in Lung Cancer Clinical Trials

There are many reasons to be interested in participating in a clinical trial. Anyone can participate in a clinical trial if there’s one appropriate for their health status. There are clinical trials for all stages of cancer. Some require patients not to have had any treatments, while others are specifically for treatment-resistant or recurrent lung cancers.

You may be especially interested in lung cancer clinical trials if standard therapies are no longer working for your cancer or are not likely to give you a good outcome. But participation in clinical trials has pros and cons.

The benefits of lung cancer clinical trials include:

• The new treatment may be more effective than what's available.
• The study treatment may have fewer side effects.
• Your participation can benefit future patients.
• You’ll get access to treatments, including those that may not be available in other ways.
• The trial team will closely monitor your health.

The risks of lung cancer clinical trials include:

• The treatment you receive may not be a more effective treatment than what you've tried.
• The new treatment may not work better than the standard treatment.
• The treatment being studied may have more or unexpected side effects.
• Traveling to and from treatment may be more expensive.
• You may spend more of your time getting care during additional visits and more tests.
• Your care costs may not be fully covered by health insurance.
• Additional testing may be uncomfortable.
• If the new treatment is beneficial, it may not be better for all patients.

One note about clinical trials for cancer. Whether you’re in the treatment group or not, you’ll still get treatment. It’s very unlikely you’ll be in a trial with a placebo (an inactive treatment given to some trial participants as part of a control group). Almost all cancer clinical trials compare new treatments against “standard” treatment, not “placebo” treatment.

You'd only get a placebo treatment in a cancer clinical trial if there is no standard treatment or a good option for your cancer’s stage and type. The use of a placebo group will be laid out in the clinical trial details if it's the case for you.

Where to Find Them 

Enrolling in a lung cancer clinical trial may help you access new or current treatment, but it takes many steps. First, you’ll want to discuss your desire to participate in a clinical trial with your cancer care team. Then, you’ll need to find clinical trials for your stage and type of cancer that are currently enrolling patients near you.

Many different groups sponsor clinical trials. There is no single place to find them all. The National Cancer Institute's (NCI) database and clincialtrial.gov are good places to start.

You’ll also want to check with:

• Major cancer centers
• Drug and biotechnology companies
• Cancer advocacy groups, for instance, Lung Cancer Foundation of America
• Clinical trial listing services, for example, CenterWatch

The NCI's Cancer Information Service can perform a tailored clinical trials search for you by calling 800-4-CANCER (800-422-6237) and selecting option two or connecting with their cancer information specialists online.

Once you’ve found a lung cancer clinical trial that is a good fit, you can move forward with applying to and enrolling in the study. 

How to Apply and Enrollment Steps 

The process of applying to and enrolling in a clinical trial includes many steps. 

Review the Eligibility Criteria

Before you apply to participate in a lung cancer clinical trial, you’ll need to meet the eligibility criteria detailed in the protocol and understand if the trial fits your needs in other ways. Your cancer care team can help you gather information and decide what types of treatment to consider.

This checklist from the NIH can help you gather all the necessary information from your healthcare team while looking for and considering a clinical trial.

When looking at the clinical trial information, pay attention to the trial protocol, which includes the most important information about the clinical trial.

• How long the study will go on: It may require you to participate in the trial for years.
• What drugs will be given to and tests performed on participants
• How often you’ll need to schedule doctor’s visits, treatments, and tests
• Details about who can participate in the trial: This is where you’ll see if your cancer type and staging match up with those being studied.
• Where the trial is being held: Make sure you will be able to travel to the trial location as needed by the treatment protocol. Will you be able to afford to travel, or do you need the trial sponsor to pay your travel costs?

You also want to review the clinical trial’s objective, outcomes, or endpoints to ensure they meet your treatment goals. These endpoints are not just limited to survival. They may include one or more other endpoints, including:

• Curing your cancer
• Prolonging cancer survival
• Slowing the spread of cancer 
• Shrinking the cancerous tumor
• Reducing symptoms of cancer 
• Reducing treatment side effects
• Improving your quality of life 
• Testing the safety of new treatments
• Testing the side effects of new treatments

To ask questions and find out more about the trial, find the contact information in the trial protocol and get in touch with the research team. The best person to talk to is the trial coordinator. They’ll be able to answer your questions and verify your eligibility to participate in the trial.

If you don’t feel comfortable discussing your participation directly, ask your care team member to contact them for you. It's also possible that the clinical trial team may reach out to you if you’ve signed up for a clinical trial listing service.

Give Informed Consent

Once you’ve applied for a lung cancer clinical trial, you’ll sit down with a member of the clinical trial team to discuss the trial and give them your informed consent to participate in the trial. They'll review everything about the trial and answer all of your questions. 

The actual informed consent is a document that you sign. It will have information about the trial, including:

• The reason for the study
• Who is eligible for it
• What the researchers know about the treatment 
• The risks and benefits
• Other treatment options
• The design of the study 
• The tests and visits you’ll need to participate in 
• Who will pay for these visits (and any other care you need due to the trial)
• How the study team will protect your identity
• A statement saying you understand you can leave the study at any time
• Contact information to get your questions answered

Before you sign the document, make sure you fully understand each section and what it means for you. You can have your cancer care team review the document, too. 

Pre-Research Tests 

If you’re a good match for a trial, you may undergo testing before being fully admitted to the trial. This testing will begin after you sign the consent form. Pretrial testing may include:

• Imaging tests
• Blood tests
• A physical exam and personal medical history

Questions to Ask Researchers 

You’ll likely have many questions throughout the trial process. Talk to your cancer care team and the trial coordinator to get answers. In addition to all the questions and details reviewed above, there may be some additional questions you want to ask your care team, the trial coordinator, or your health insurance representative. These may include:

• Why do you believe the studied treatment might be better than standard therapy? Why might it not be better?
• How does the treatment I would receive in this trial compare with the other treatment choices?
• How do this trial's possible risks and benefits compare to the standard treatment?
• How could the trial affect my daily life?
• Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
• How will the doctor know if the treatment is working, and what will happen if not?
• Can I talk to someone who has been in the trial?

Factors That May Affect Eligibility

Many factors influence your eligibility for a clinical trial. These can include:

• Your general health
• Your age
• Your medical history
• Your cancer’s status 
• What previous cancer treatments you’ve undergone (or lack thereof)
• If your cancer has come back after being treated
• The type of cancer you have
• The genetics of your cancer
• Other cancer characteristics
• Your original cancer tumor’s size
• If your cancer has metastasized (spread) to other organs

Safety Standards 

The Food and Drug Administration (FDA) holds clinical trials to high safety standards. Federal rules manage clinical trials to ensure they are safe and ethical for participants. These rules ensure your safety is taken into account at every stage of the process, as in the following ways:

• The development and approval of the experimental protocol by scientific experts, an institutional review board (IRB), and the FDA
• Your review and signing of the informed consent to make sure you understand what you’re participation entails
• Ongoing monitoring of the trial by the research team, the sponsor, and the institutional review board. 
• The Data Safety Monitoring Boards monitoring phase 3 trials

Monitoring during the study may result in the protocol being changed or the trial being stopped if patient safety is at risk. 

You Can Leave at Any Time 

Taking part in a clinical trial is entirely up to you. You can choose to leave the study for any reason at any point in the clinical trial process. Talk to the trial team about why you’re quitting—it may provide the research team with helpful information. 

Even if you are no longer getting treatment through the clinical trial, trial representatives may still want to follow up with you to see if the treatment has any long-term effects they weren’t expecting.

Estimated Participant Costs

Clinical trials are not free. There will likely be some costs for you to participate in a clinical trial. Your health insurance plan may cover some of the fees. Clinical trial costs are of two types: patient care costs and research costs.

Patient care costs include the costs for healthcare providers and hospital visits and standard tests or treatments related to your cancer. Your health insurance will likely cover this. 

Research costs are specifically related to the experimental treatment and testing for the trial. Research costs can include the drug itself and additional lab or imaging tests included in the study protocol. Health insurance will not cover these costs, but the study’s sponsor may pay for them. 

Some clinical trials will reimburse your travel costs. There may be costs for transportation to and from visits to the healthcare provider and testing and treatment. This is especially true if:

• You’re traveling farther for a clinical trial than you would to visit your cancer care team.
• You need to plan to stay overnight at the clinical trial location.
• You have children or older relatives that need to be taken care of while you’re away.
  

You’ll want to review the costs laid out in the informed consent document and the treatment protocol for the study and ask questions about any details you’re unsure of. It would help to discuss treatment costs with your health insurance representative.

Some questions you’ll want to get clear answers to before committing to the trial include:

• What will I have to pay if I take part in the trial?
• Will my health insurance cover any of these costs?
• Who pays if I’m injured during the trial?
• Who will help answer my insurance company’s questions about the trial?
• Whom do I talk to about bills I receive during the trial?

Phases of Clinical Trials

• There are four “phases” of a clinical trial, all with different purposes. Once a treatment passes one phase, a new trial can be designed and enrolled for the next phase. Phases include:
• Phase 1 clinical trials study a few people to determine if the treatment is safe, how to dose it, and how to administer it.
• Phase 2 determines if the treatment is effective in a small number of patients.
• Phase 3 determines if the treatment is more effective than standard therapy. 
• Phase 4 clinical trials typically occur after FDA approval of the treatment to study the treatment’s long-term side effects.

If You Don’t Qualify

If there are no clinical trials you qualify for, discuss your treatment options with your healthcare provider. 

You may decide to undergo standard treatment or opt for palliative care treatments, which are aimed to help reduce your symptoms rather than be curative.

What you choose depends on what your treatment goals are. You may want to focus on curing your cancer by undergoing more treatments, or you may want to focus on improving your quality of life with fewer interventions. 

If you’d still like to try the treatment being studied but don't qualify for the clinical trial, your healthcare provider can ask the trial coordinator or principal investigator for an eligibility waiver or special exception. The waiver will mean you’d get the same study protocol treatment, but the researchers will not include your data in the study results.

Requesting Compassionate Drug Use

If you and your healthcare provider think a new drug in clinical trials may be useful to you, you could also request compassionate use. Compassionate use is a treatment that is not standard but may offer benefits. It is usually only an option when a patient has run out of other therapies that may be effective. 

You may not be able to participate in the clinical trial, even with a waiver, if you live too far away, are too unhealthy, or don’t meet other requirements. Two programs allow people to access new drugs in clinical trials without participating in the trial, which are:

• Expanded access programs (EAPs) provide drugs to patients with serious and life-threatening conditions who are ineligible for clinical trials, have no other treatment options, and are likely to benefit. Expanded access is requested from the FDA by your healthcare provider.
• The Right to Try Act, passed in 2018, lets people request drugs that have passed phase 1 clinical trials directly from the company that makes them. People attempting a Right to Try request need to have a life-threatening condition, have tried all approved treatments, be unable to participate in the clinical trial, and give informed consent that they understand the risks involved in taking the new drug.

Not all drugs are available this way. Drug companies are not required to give their drugs for compassionate use. They are also not required to give it to you for free—so it may be expensive.

Some of these drugs are so new that they don’t have enough of them on hand to use on people other than those in the trial, another reason that they may decline compassionate use requests.

Summary

Clinical trials for lung cancer are an option for many people. If you’re interested in participating in a clinical trial, talk to your healthcare provider. Search for a clinical trial that fits your specific cancer type and stage. Apply to the trial, and you’ll be enrolled after pretrial testing and informed consent. Clinical trials are designed with your safety in mind but have risks and benefits, including costs.

A Word From Verywell

Being faced with a lung cancer diagnosis is scary. Even scarier is knowing your lung cancer has come back or spread. Participating in a clinical trial can help you face the negative outlook of many of these cancers, especially knowing you’re helping cancer patients that come after you.

Your participation in a lung cancer clinical trial may or may not prolong your life, but it will leave a lasting impact on cancer care for decades to come.