I joined a clinical trial

My most fascinating experience this year, other than catching a glimpse of the sun’s corona? I joined a clinical trial.

I’ll be honest. When somebody multiple years into their cancer treatment enters a clinical trial, it is typically the result of learning some bad news.  I’ll start with the bad, but I want to make it clear: I believe that entering this trial might well have been the very best thing that happened to me in 2024.

Since my diagnosis in 2019, I have received regular brain MRIs. One such scan was in July, a day after I returned to work after a two-week vacation.  The result after 4.5 years of stable scans on a 2nd generation pill? New lesions, 10mm and 4mm in size.

My oncologist’s first suggestion was for me to receive radiation.  I wasn’t excited by this idea, as I have many friends who have dealt with radiation necrosis in their brains, and I wanted to avoid it as a potential side effect.

My oncologist’s second suggestion was to switch to a different, 3rd generation pill: lorlatinib.  This was a reasonable suggestion, too.  This drug was actually the subject of an article in The Guardian earlier this year with the headline, “Trial results for new lung cancer drug are ‘off the charts’, say doctors.” So, why wasn’t I excited about switching to this drug? Unfortunately, it is well known for causing cognitive side effects. I have friends who have left the workforce entirely after starting lorlatinib, feeling that they cannot possibly keep up.

When I compared these two options against the possibility of joining the clinical trial of a 4th generation pill, the trial won on every dimension except for one: In order to receive NVL-655, I’d have to switch to receive my cancer care at a hospital where the trial is available. Of 21 such sites in the United States, the closest to me is at The Ohio State University, 193 miles away from my home in Western Pennsylvania.

When I carefully considered my options, it was clear to me what choice would be right for me. And so, during almost every week between July and November, I traveled three hours each way to Columbus, Ohio, to fulfill my obligations as part of a worldwide science experiment.

I received my first dose of NVL-655 on August 12, after a brief washout period during which I could no longer take my previous pill. It wasn’t long before I started noticing some side effects, and as a research subject, it is my duty to carefully track and report all of them to my care team.

The first thing I noticed is that some things tasted a bit different than before. It wasn’t long before I suspected that the drug might be causing me to be hyperactive, too. I found myself going to bed an hour later than usual and would nonetheless wake up an hour earlier than usual, full of energy. I found myself skipping my usual afternoon nap. Before long, I felt that I was running hard, but I was also getting more work done in four work days a week than I did previously in five.

I asked somebody who knows me well (my sister) whether she thought that the medication might be causing me to be hyperactive. What did she say? “You’re not hyperactive. This is who you were before cancer.” I had spent several years, at that point, thinking that I had gone on a pill and returned to my normal life, just as my first medical oncologist predicted I would after my diagnosis. Little did I know that I’d been living that normal life for 5+ years with the brakes on, and now I could finally run free.

I learned a lesson, too, about power dynamics. I know now what it is like to be reminded that I must follow instructions precisely, and if I do not repeatedly, then my care team will label me as Noncompliant, and then the Sponsor would gain the option of removing me from the trial. Of course, if that were to happen, I would no longer be able to receive my cancer treatment. I also learned what it is like to take an entire day off work so that an OSU lab can perform routine tests on a single tube of my blood. I did this three times, actually, and each had to occur within a specific three-day window. In short, I don’t feel that the process is designed to value my time very highly, but I eventually found comfort in the following line of thinking: I want my friends to be able to take this pill, too, as soon as possible, and my compliance will only help expedite this.

As for effectiveness? I traveled to OSU for the pinnacle of the research study on November 6 and 7. My examinations included an eye exam, a blood draw, a CT scan, and a brain MRI. And you know what? The tumor that was 10mm originally had shrunk to 6mm by 4mm. The 4mm tumor had become “so small it cannot be measured,” according to my report. Since November, my visit frequency has decreased to once every 4 weeks. It will further decrease to once every 8 weeks, then 12 weeks, over the next several months.

Thank you to my care team and everyone at Nuvalent who played a role in keeping me alive and able to work throughout 2024 and beyond. Nuvalent’s leadership regularly engages with the ALK Positive patient community, and I am grateful to have regular opportunities for dialogue with them. Special thanks to Dr. Vincent Lam for suggesting that this trial might be the best fit for me. I’m hoping for many more years on this pill.