Pre-Clinical Research Sets the Stage for Clinical Trials
Clinical trials are studies that are done in humans to test a new treatment. Long before a clinical trial, a host of “pre-clinical” studies must test the feasibility, safety, and effectiveness of a new treatment. Preliminary work involves chemistry to develop a compound that can be manufactured and has the potential to inhibit cancer growth. That compound is then tested for safety and effectiveness.
In ALK-positive lung cancer, cancer cells are taken from live biopsies, then grown in a lab for testing. The cancer cells that live in a lab are called “cell lines”. The biopsies that produce the cell lines are from those patients who have just been diagnosed with ALK lung cancer along with those who have acquired resistance after treatment.
Once a drug is developed, the first step is testing the effectiveness of the new compound in a lab medium, or what we consider a “petri dish”. These experiments are called “in vitro” studies, meaning they are done outside a living body. If the new treatment shows promise, cancer cell lines from humans are implanted in animals (usually mice) and the new treatment is tested to see if it prevents growth in tumors implanted in the animal. These are “in vivo” studies, meaning the experiment is done on a living organism. The mice studies give important findings on safety, dosing, and effectiveness.
If the studies in mice show that the new treatment is useful, a clinical trial is designed for testing in humans. In “first-in-human” studies, very low doses are given to a very small number of people to make sure the findings from the animal studies translate to humans.
At our summit this year, we heard from several researchers who are involved in pre-clinical studies of ALK-positive lung cancer. They have developed several new strategies to tackle ALK-positive lung cancer, beyond what is available through TKI ALK inhibitors. The ALK Positive Research Fund has enabled these researchers to develop unique treatments for ALK-positive lung cancer, which we hope will progress to clinical trials in the future.
ALK LUNG CANCER CLINICAL TRIAL HELP AND SEARCHING
ALK Positive Support Group Clinical Trials Spreadsheet*
GO2 Foundation for Lung Cancer - LUNGMATCH
LUNGevity Online Clinical Trial Finder
CenterWatch Clinical Trials Search
MassiveBio Clinical Trials Search
General Info about ALK NSCLC Clinical Trials
As of August 2022, there are at least 50 clinical trials that are recruiting specifically for people with ALK-positive lung cancer. Many of these trials have multiple sites worldwide. Since ALK-positive lung cancer is a rare disease, it is difficult for any one oncologist to be aware of all the trials available. You can advocate for yourself and find a clinical trial that may be a good fit for you at any juncture in treatment.
*The ALK Positive Clinical Trials Spreadsheet was developed by the ALK Positive Medical Committee. The database is updated monthly. Disclaimer: these trials have been consolidated by volunteers and should not be considered exhaustive. Listing of these trials is not an endorsement, and ALK Positive does not recommend one trial over another. Please talk with your doctor about these or any trials you are interested in.
Author: Ellee Urban