ALK Lung Cancer Clinical Trials Recruiting (Current as of Jan 2020)

Clinical trials play an important role in the long-term survival of many lung cancer patients. Below is a compilation of resources that will help ALK-positive patients and their care teams identify suitable clinical trials that are open to them. Bonus feature: an ALK-positive patient opens up about their experience in the Brightstar Clinical Trial.

OPEN AND RECRUITING ALK CLINICAL TRIALS:

New Trial

Exciting new clinical trial in San Francisco! Recruitment has begun for the Brigatinib/Binimetinib trial. This is a combo of an ALK inhibitor (Brigatinib) with a MEK inhibitor (binimetinib). MEK is a pathway that causes resistance to ALK medicines outside of the ALK domain. So the hope is that Brigatinib will cover ALK and its sub-mutations, and binimetinib will prevent or delay the emergence of non-ALK resistance. (There is a similar trial recruiting in Boston that is testing the combo of Alectinib and cobimetinib).

This is a phase 1 trial, meaning they are trying to find the safe and tolerable doses of the agents. It is open to those with ALK NSCLC or ROS-1 who have had recurrence or intolerance to their most recent ALK inhibitor. Interestingly, they are also doing blood biopsies to see if the results correlate with clinical response.

It is linked to a program called IMPACT, which may reimburse the costs of travel for those in the US who don't live near San Francisco. 

https://clinicaltrials.gov/ct2/show/NCT04005144

Clinical Trial Help and Searching:

General Info about ALK NSCLC Clinical Trials:

https://docs.google.com/document/d/1-otPfoO7ssPZ4ZGAIZUhXLNF-jWVpvUsbQJzRbMcNjA/edit?usp=sharing

An ALK Positive Member Opens Up About his Experience in the Brightstar Clinical Trial

The Brightstar Clinical Trial at MD Anderson in Houston, Texas USA is a first-line study of the ALK inhibitor Brigatinib combined with local consolidative treatment, such as surgery or radiation.  ALK-inhibitor naive participants are given Brigatinib for several weeks, then local treatment is given to any areas of residual disease. Brigatinib is continued after the local treatment. The hope is that by adding local treatment early on, Brigatinib will be effective for a longer period.


I had a recurrence of stage 1A lung cancer in late summer of 2019, which was followed by one infusion of strong chemo. Two weeks later, I found out I was ALK-positive. I received the call from my oncologist on 9.17.19 advising of the ALK+ status and offering/recommending the Brightstar trial. Three days later, I walked out of MD Anderson with Brigatinib.

My decision to enroll in the trial was twofold. I appreciated that the trial would enable me to take Brigatinib to treat my cancer. I was also intrigued by the idea of combining it with local treatment. 

I am absolutely satisfied with my decision to enroll in the trial. I noticed improvement on Brigatinib almost immediately. I just had my 8 week scans and I've had a great response. I am now scheduled for 20 rounds of radiation at the end of December.  I’ve gained a few pounds, my blood pressure and cholesterol have ticked up a bit, but nothing to be too concerned with. Physically and mentally, I feel great!

I appreciate that, while on the trial, I am monitored more frequently.

I am amazed by how far research has come. Every single night as I count out my tablets, I am reminded of the importance of research.  Prior to diagnosis, I had very little reason to get involved in cancer research or become an advocate, but now that I am on the receiving end I am forever grateful! Research matters! It’s important that we continue to carry the torch for those that have gone before us. Their efforts made a difference for us today and we too can make a difference for those that will come after us.” 

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As of December 2019, there are at least 27 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.

*Spreadsheet developed by ALK Positive Volunteer Ellee Urban and ALK Positive MPAC in August 2018. Updated monthly and posted in the ALK Positive Support Group.

Disclaimer: these trials have been consolidated by a volunteer 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.

Cori Casebeer