Clinical trial vs standard treatment

[Babs]

Hi all,

So I’ve had a recurrence and I need to make a decision of whether to do a clinical trial or standard chemo/immuno.  The clinical trial is a new drug Datopotamab Deruxtecan combined with Keytruda and possibly Carboplatin.  It’s a phase 1 trial through the Mayo Clinic.  The standard treatment would be Taxotere and Cymraza which I believe is a pretty tough combo.  I had a video visit with my Onc here yesterday and she brought up a good point that the standard treatment would always be available but not this clinical trial.  If I’m going to do this clinical trial it’s now or I can’t as doing the standard treatment would make me ineligible.  It would mean a long battery of tests including another biopsy and several trips down to the Mayo.  
 

https://clinicaltrials.gov/ct2/show/NCT04526691

I’m not sure what questions I should be asking about the trial.  Does anybody have any input out there?  I’m very confused of which way to go.

Thanks,

Babs

[LexieCat]

Welp, having just gone through this exact scenario, my biggest concerns were what was actually involved in the trial treatment, what happens after the trial treatment is done, asking about what kind of results they'd had in prior trials, eligibility criteria, and whether participating would eliminate other courses of treatment.

The trial I'm doing is pretty brutal, physically, but it's of rather short duration. The upside, if it works, is that it's one-and-done--no ongoing chemo/immunotherapy afterward. In my case, too--I would probably be ineligible if I went to the next line of treatment. I'm healthy enough right now to withstand the treatment, too. The doc running the trial says about the only treatment this would knock me out of would be additional clinical trials where eligibility depended on never having had immunotherapy. Of course, I've already HAD immunotherapy, and the doc pointed out that these days, almost everyone has, so there would be very few trials that would preclude me on that basis. 

I contacted someone at the Go2 foundation to run it by another brain and make sure I wasn't overlooking any important considerations. They can also help identify any other trials you might be eligible for. There were three right in my general area--the one I'm doing, and two at Penn, where I've been getting treated since my Stage IV diagnosis. If this one didn't pan out, my oncologist at Penn had already confirmed my eligibility for the two there. Those also looked interesting, but one of them involved infusions every week for nine weeks (the thought of which didn't thrill me) and the other (which probably would have been my second choice) involved two injections of a drug into the tumor, seven weeks apart, and then ongoing chemo/immunotherapy infusions--IOW, similar to the course of treatment I've been on for months. 

I decided to, as my oncologist described it, "swing for the fences" and take a shot at getting rid of the cancer completely. It may not work but I doubt I'll be worse off for having tried.

[Babs]

Lexie,

Thanks!  You bring up excellent questions.  I have asked some of them.  Did you just call the main number at Go2 foundation or was there a different one to inquire about the clinical trials?  
 

Thanks for your input,

Babs

[LexieCat]

I talked to a guy named Andrew--Rower Michelle gave me his name and number--but he said really, the best thing to do was to call 1-800-298-2436 and anyone there can help navigate clinical trials.

[TJM]

Babs

Lexie is a rock star and is doing all of us a great service by sharing everything and in a detailed and thoughtful way.

Please keep us informed. I am especially interested because I have no clue what my second line treatment for Large cell would be. I am very up to speed on most of the options and non seems particularly promising and my Onc keeps saying we'll cross that bridge when it comes. I'm starting to think he wants to cross the retirement bridge first (his).

I am NED for now so I'll stick with him because I'm lazy. If I do get a recurrence that will change if he doesn't.

So stories like yours and Lexi's are of keen interest. Wishing you the best

Peace

Tom

[LUNGevityKristin]

Hi! LUNGevity has many resources available for those considering clinical trials.  You can speak with a clinical trial ambassador (someone that has been through the process as a patient) that will walk you through the clinical trial process and answer any questions: https://lungevity.org/for-patients-caregivers/support-services/peer-to-peer-mentoring/clinical-trial-ambassadors

LUNGevity also has clinical trial navigators that you can speak with: https://app.emergingmed.com/lcctal/home

If you have any questions about these resources or need additional information, please let me know!

[Babs]

Thanks everybody.  I will certainly reach out tomorrow to all the resources you all have provided.  It’s not easy making these decisions, but I know I’m blessed to have options.  I’ll keep you all updated. 
 

Babs

[LouT]

Babs,

Good luck with your decision.  Perhaps the information you now have can provide you with "other minds" to help you weigh the pros and cons of each option.

Looking forward to hearing what you decide.

Lou

[Babs]

Hi all,

So here’s an update on my clinical trial. I reached out to both Go 2 foundation and Lungevity.  I’m still trying to connect to Lungevity but did speak to a very helpful Daniel at Go 2 and received some additional information about the trial.  It appears in the trial there are 2 phases , phase 1 being dose escalation and phase 2 being dose expansion.  From what I was able to understand, I wouldn’t be eligible for the phase 2, dose expansion as I have had both immunotherapy and systemic chemo treatment. The way I understand it is, they would start everybody in the dose escalation phase, on the lowest dose of the drug and increase or escalate the dose.  Those that are eligible for the phase 2, the dose expansion would continue on to the “ dose of interest”, the dose that the benefit outweighs the risk, but I wouldn’t be part of that group. I’m trying to understand if this is something that I would even want to do or if I am even really understanding this? Can anybody shed some light onto this or tell me if this even makes any sense?  
 

Thanks in advance,

Babs

[LexieCat]

I think you should probably talk to someone at Mayo about those questions. You'd have to go through a screening process with them, anyway.

Is that the only trial you asked about, or did you ask them to search for others for which you might be eligible? Seems to me like there should be quite a few that you'd be eligible for. 

Another option is the National Cancer Institute--when you participate in one of their trials, they cover your expenses.

[Babs]

Yes, I have an appointment with the Doctor at Mayo tomorrow so I will be asking those questions.  Go 2 did find another trial that I will be talking to the Doctor about.  It’s an immunotherapy combo phase II trial.  It’s with the University of Minnesota, so I would need to be referred.  I am still waiting to connect with Lungevity so there’s that avenue also.  Thanks for your input!!

[LexieCat]

Sure--incidentally, my former oncologist at MD Anderson--Cooper, who left just before my recurrence last year was diagnosed, is at Allina Health there in Minneapolis. Let me know if you'd like me to ask him anything, but sounds like you have a few folks helping you.

Good luck, and let us know how you make out! I have the impression that if the drug is working for you, you'd be continued on it even if you couldn't participate in the trial for the dose expansion. IOW, you wouldn't be left high and dry, you just wouldn't be a data point in the other trial.