Author: GO2 for Lung Cancer Associate Director, Clinical Research, Andrew Ciupek, PhD

With an increasing number of targeted therapies becoming available, making treatment decisions based on the results of biomarker testing has become an essential part of cancer care – especially in lung cancer. At the same time, researchers are also coming up with new ways to do clinical trials that could bring new targeted therapy options to patients faster and more efficiently. Several new clinical trial designs are helping with this.

New types of clinical trial designs

A few key examples of the new trial designs are:

  • Basket trials
    • How it works: In this type of trial, a single targeted therapy associated with a specific biomarker is given to people whose tumor has tested positive for that biomarker, regardless of the type of cancer.
    • Goal: This type of clinical trial design can speed the testing of a new targeted therapy for multiple cancer types since a new clinical trial doesn’t have to start for each specific cancer.
  • Umbrella trials
    • How it works: In this type of trial, multiple targeted therapies are tested on individuals with the same cancer type (such as non-small cell lung cancer). People are “matched” to specific targeted therapies based on the results of comprehensive biomarker testing.
    • Goal: This type of clinical trial design can speed the testing of targeted therapies for a specific type of cancer since a new clinical trial doesn’t have to start for each targeted therapy.
  • Platform trials
    • How it works: In this type of trial, multiple treatments are tested at the same time, and the study can be “adapted” or changed as we better understand the best treatments. For example, certain treatments can be removed if they do not seem to be working and/or new treatments can be added if new data shows they may be good options.
    • Goal: This design can make testing new treatments faster by allowing changes to the trial based on new understanding while the trial is still active. This allows for some flexibility, rather than waiting for a trial to be fully complete to test a new treatment or starting a new trial if new information is found supporting a new way of treating cancer.

Examples of trials with new design types

  • Lung-MAP
    • The Lung-MAP (Lung Cancer Master Protocol) trial is an umbrella trial for advanced lung cancer that has progressed after receiving standard treatment. This trial is testing several targeted therapies at the same time with people being “matched” to a drug based on their biomarker testing results. If the testing results do not match with a targeted therapy on the trial, then people can choose to join a part of the trial testing immunotherapy.
  • ALCHEMIST
    • The ALCHEMIST trial tested if targeted therapies could reduce the chance of early-stage lung cancer returning after surgery and initial treatment. This trial also looked at several different targeted therapies within the same trial. People who had completed initial treatment for early-stage lung cancer (surgery and any follow-up chemotherapy or radiation the doctor recommended) would match to a targeted therapy on the trial based on biomarker testing results.
  • NCI-MATCH 
    • The NCI-MATCH (Molecular Analysis for Therapy Choice) trial tested if matching people to targeted therapies based on their biomarker testing results was effective, regardless of the type of cancer it was. The trial allowed people diagnosed with multiple types of cancer to join and receive one of several different targeted therapy treatments based on their biomarker testing results.
  • TAPUR
    • The currently active TAPUR (Targeted Agent and Profiling Utilization Registry) trial is looking to see if targeted therapies that have been approved for one cancer type would work for other cancer types that have the same mutation or change in them. People with an advanced cancer that is not responding to standard treatment but also have a mutation or change that matches one of the targeted therapies in the trial could join and receive the matched drug. TAPUR is looking at 17 targeted therapy treatments and can grow or close individual parts of the trial based on how well a treatment appears to be working.

These new clinical trial designs and others are increasing the options people with cancer have available. Your treatment team can discuss clinical trial options that may be relevant to you.

If you would like to learn more about clinical trial options, contact the GO2 HelpLine 1-800-298-2436 or email support@go2.org to talk one-on-one with an expert LungMATCH navigator.