If you have EGFR-positive lung cancer, you have some choices to make about treatment options. Especially if your cancer is advanced.
Your doctors can help you choose from a list of approved drugs that work by targeting the EGFR mutation your non-small-cell lung cancer (NSCLC) carries. But that wasn’t always true.
Before they were available to you, each of those meds went through a long process of development and discovery that included a clinical trial.
Around the world, dozens of clinical trials are now recruiting people who have NSCLC with an EGFR mutation. But before enrolling in a trial, there’s a lot to think about.
Clinical trials can be a good option when you have EGFR-positive NSCLC.
Why Should I Think About a Clinical Trial?
Before any new cancer treatment becomes available for general use, it has to be thoroughly tested in clinical trials. Those trials have to show that a new medicine is safe. They find out what dose is needed. And they also have to show that a new medicine works to slow or stop the cancer.
All the new EGFR inhibitors available to you now are there because of other people with EGFR-positive NSCLC who enrolled in clinical trials in the past. But there’s still no cure for advanced EGFR-positive lung cancer. Scientists and doctors are still working on new and better ways to treat this form of NSCLC. Any time you need cancer treatment, a clinical trial is something for you to think about. Clinical trials may be an option all throughout your cancer journey. Some trials include people who are newly diagnosed while others look for people who’ve gotten worse after an earlier treatment. Your doctor may suggest a clinical trial if your cancer stops responding to approved treatments or if they aren’t working as well as they’d hoped.
Clinical trials are the bridge that moves the most promising new treatments developed through basic research into routine use by doctors to help people with NSCLC live longer or have a better quality of life. While there’s no guarantee that a new drug doctors are testing in a clinical trial will work for you, trials give you access to the newest medicines even before they’re proven. There will be risks and benefits you need to think through. Clinical trials aren’t for everyone and it’s a personal decision. But you may want to think about and enroll in a trial for lots of reasons, including:
- Other treatments for your EGFR-positive lung cancer didn’t work or didn’t work well enough.
- You want to try new treatments or new treatment combinations.
- You want to have more treatment options.
- You want to play an active role in your treatment.
- You want to help researchers learn more about how best to treat EGFR-positive NSCLC.
- You want to be part of expanding treatment options for others with EGFR-positive NSCLC in the future.
How Do I Find Trials for EGFR-Positive NSCLC?
If you think you might want to consider a clinical trial, start with your doctor. Your doctor might know about trials in your area that could work for you. They also can talk to you about the possibility of a trial and whether that makes sense to think about right now, or perhaps down the road.
Even if you might not join a trial right away, it doesn’t hurt to look at what’s out there.
If you’re getting treated at a larger cancer center, ask your doctor if there are any clinical trials right for you. Or you might look online for info about clinical trials for people with EGFR-positive lung cancer.
Clinicaltrials.gov is a helpful website place for finding trials anywhere in the world. If you enter “EGFR” and “non-small cell lung cancer” in the “condition or disease” or “other terms” fields, you’ll find dozens of trials.
To specify that it needs to be an open trial, click the box for “recruiting.” Click your age group, sex, and other criteria to help find trials that are likely options for you. But pay close attention to where the trials you find are taking place.
You can specify if you’re only interested in studies in the U.S., or how far you’re willing to travel from where you live.
Clinical trials in EGFR-positive NSCLC test different kinds of treatments and approaches. They’ll change as new ones open and others stop recruiting or come to completion. Current open trials in EGFR-positive NSCLC include those looking at:
- Adding a second EGFR inhibitor after EGFR-positive NSCLC starts resisting earlier treatment
- Adding new drugs to EGFR inhibitors that are already approved
- Using more than one EGFR inhibitor as a first-line treatment
Not all trials test new treatments or new treatment combinations.
Some may focus on finding better ways to treat people or ways to learn more about lung cancer. For example, one current trial is testing the use of a smartphone app to track and treat symptoms when you’re in treatment for EGFR-positive NSCLC.
Another trial is looking closely at EGFR and related genes to learn more about their role in NSCLC and its outcomes.
So even if you don’t necessarily want to try a new drug, you may be able to help improve treatment for EGFR-positive lung cancer by joining a trial.
How Do I Choose a Trial?
Once you find a trial you’re interested in, you’ll want to look closely at the details. Clinical trials have clear plans, or protocols, that lay out how that trial will be done and the purpose of each step.
A protocol also will specify requirements for participation. These are called eligibility criteria.
You’ll want to read these carefully and review them with your doctor to see if the trial you’re thinking about might be a good fit. To be in a trial for a new EGFR-positive NSCLC treatment, you may need to:
- Be at least 18 years old
- Have confirmed NSCLC of a certain stage
- Have an EGFR mutation
- Be reasonably healthy otherwise, based on your blood or other tests
- Be willing to give blood, tissue, or other samples as needed for the study
- Have had previous treatments that are consistent with the trial protocol
Each trial also will have “exclusion criteria.” These are things that will mean you aren’t a candidate for that trial. For example, you may not be able to participate in a trial if you’ve had:
- Radiation therapy
- Bone marrow or organ transplant
- Certain medical procedures
- Certain other health conditions, such as uncontrolled sleep apnea or a heart attack
- A severe or chronic medical or mental health condition
Each trial is different, so you’ll want to read the criteria closely. It’s likely you’ll be a candidate for some trials and not others.
The goal is to find a trial that’s a good match for you.
Are There Risks?
Yes. All trials have some level of risk, but the risk may be small and vary from trial to trial.
Both risks and benefits of a clinical trial depend on your cancer and how your treatment is going. They’ll also depend on your values and preferences.
Talk to your doctor or the clinical trial coordinator about risks associated with a trial you’re considering. In general, possible risks include:
- The new treatment or treatment combination may not work.
- The new treatment or treatment combination may not work better than other treatments that are already available.
- The new treatment or treatment combination may have worse side effects.
- You might need to go to the doctor more than you would otherwise.
- You might have some extra costs, for instance if you need to travel.
- You might need more tests, such as blood tests or biopsies.
- Even if the new treatment works, it might not work for you.
- Even if it does work, your cancer may still grow, and your new treatment might not change your outcome.
- Your health insurance or the trial may not cover all your costs.
Questions to Ask When You’re Thinking about a Clinical Trial for EGFR-Positive NSCLC
No matter where you are in thinking about a trial, don’t hesitate to ask questions of your doctor, nurse, or trial coordinator.
Write down your questions ahead of time. Here’s a list of some you may want to ask:
- Should I consider a clinical trial?
- What’s this trial about?
- Why would the treatment it's testing work better?
- Am I a candidate for this trial? Why or why not?
- If I’m not a candidate now, is it possible I would be later?
- If I’m not a candidate for this trial, what about a different trial?
- How long will the trial last?
- What will I need to do if I’m in it?
- Will I have to get more tests done than if I weren’t in the trial?
- What if the experimental treatment doesn’t work for me?
- How will anyone know if the treatment is working?
- How will I find out the results of the trial?
- What if I have questions during the trial?
- Who will take care of me if I’m in the trial?
- Can I talk to someone else who’s in the trial?
- What side effects do I need to watch for?
- What will happen if I have side effects?
- What if I change my mind? Can I drop out? What then?
- If I don’t want to be in a trial or I’m not eligible, what other options do I have?
Show Sources
Photo Credit: Robert Kneschke / EyeEm / Getty Images
SOURCES:
Lung Cancer Research Foundation: “FDA approvals in lung cancer treatment.”
ClinicalTrials.gov: “Recruiting Studies | EGFR lung cancer,” “Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance,” “Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC),” “Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer,” “Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies (Lung001),” “Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer.”
National Cancer Institute: “What are Clinical Trials?” “Deciding to Take Part in a Clinical Trial,” “Questions to Ask Your Doctor about Treatment Clinical Trials.”
American Cancer Society: “Clinical Trials: What You Need to Know.”
National Institute on Aging: “What are Clinical Trials and Studies?”
Memorial Sloan Kettering Cancer Institute: “Lung Cancer Clinical Trials & Research.”
Dana-Farber Cancer Institute: “Clinical Trials for EGFR-Mutant Lung Cancers.”
