Patients and Friends  >  Living with a Diagnosis of Lung Cancer  >  Table of Contents  >  Lung Cancer Research and Clinical Trials

When you are diagnosed with lung cancer, participating in a clinical trial is something you should discuss with your doctor early in your treatment process. It is important that more people with lung cancer take part in clinical trials. Research advances – and, someday, cures – cannot happen unless patients get involved in clinical research. Click here to read an article on the importance of cancer patients participating in clinical trials. If you are interested in taking part in a clinical trial and your doctor does not discuss this option with you, ask if there may be opportunities for you to participate.

Treatment-based clinical trials might involve the use of drugs, radiation therapy, surgery or other ways to treat cancer. Such trials are only performed in people after a great deal of laboratory research shows promising results.

Treatment-based clinical trials are often randomized. In clinical trials for other diseases, some patients may be given a placebo while others are given the medicine being tested, and then what happens to the patients is compared. Typically, when placebos are used in cancer clinical trials, some patients are given the placebo in addition to the best treatments currently available, while others are given the medicine being tested plus the best treatment currently available.

Participating in a clinical trial may make newer treatments available to you. The results also can help others who will be diagnosed with lung cancer in the future.

Clinical trial phases
Things you should know when searching for clinical trials
Questions to ask about clinical trials
Stories of Strength: Making the Decision to Enter a Lung Cancer Clinical Trial
Locating clinical trials

Clinical trial phases

Before a new drug, treatment or procedure is approved by the federal government’s Food and Drug Administration (FDA) for use in people, it must undergo three phases of clinical trials. Each phase is watched carefully by both the FDA and the hospitals or treatment centers where the clinical trials are carried out. It is only after all three phases are successfully completed that a new treatment can be approved for use in all patients.

A Phase I clinical trial helps determine the best amount of a drug or radiation therapy, for example, that should be used and the best way to administer a new treatment or procedure. Phase I trials also are designed to make sure the treatment is safe. About 12 to 60 people usually participate in a Phase I study. Depending on the treatment being studied, these patients may have different types of cancer, different stages of the disease and different amounts and types of prior treatment.

A Phase II trial is designed to see whether a new drug or treatment actually has a positive impact on the disease in question. As a rule of thumb, if at least 20 percent of the patients respond well to the treatment, it moves on for further testing. Most Phase II studies involve between 20 to 100 people.

A Phase III study compares a new treatment to the best existing therapies. These studies typically involve hundreds or thousands of patients in many clinics across the country or elsewhere in the world to see if the new treatment works better than one or more current treatments. A Phase III study is the only way to scientifically determine whether the new therapy works better than the treatments doctors are already using.

Things you should know when searching for clinical trials

Before you search for a clinical trial, you should know the answers to these questions:

• What type and stage of lung cancer do you have?
• Has your cancer spread within your lung and/or outside of your lung?
• What treatments have you already received for your lung cancer?
• How well do you feel despite having lung cancer? (This is known as your “performance status,” which is determined by how many standard tasks of daily living you can do and how active you are.)

Answers to these questions will help determine if you might be a candidate for a given clinical trial.

Questions to ask about clinical trials

Here are some things to consider before deciding if a clinical trial is right for you:

• What phase is the trial?
• What is known about the new drug or other treatment being used in the trial?
• Is the trial drug delivered along with the standard therapy?
• Will you get the experimental drug or a placebo? [NOTE: placebos are rarely used in cancer clinical trials.]
• Is the trial blinded? That is, will you or your health care team know which treatment you are receiving as part of the trial?
• When will the trial end?
• What happens at the end of a trial if the treatment is working for you?
• Will you be given a chance to start or continue on a new treatment if it is shown to be effective in the clinical trial?
• Will you have to pay for any part of the clinical trial? If so, will your insurance cover the trial?

Click here to view additional questions to ask your doctor about clinical trials.

Stories of Strength: Making the Decision to Enter a Lung Cancer Clinical Trial

To learn about lung cancer patients’ experiences with clinical trials, click here to view or order our video, Stories of Strength: Making the Decision to Enter a Lung Cancer Clinical Trial.

Locating clinical trials

We are very pleased to partner with Emerging Med to provide you with a personalized clinical trials matching service.

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This information is not designed to be a substitute for medical advice provided by your treatment team.

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