Novocure LUNAR clinical trial for Effect of Tumor Treating Fields

[Saturn_Bound]

Hi,

Has anyone heard of this clinical trial and, do you think it seems promising?

I am wondering if I should try to get my mom enrolled since she had progression after Keytruda:

https://clinicaltrials.gov/ct2/show/NCT02973789?term=LUNAR

 

[Jesse L.]

I've heard and became informed of the Novocure treatments and from what I understand it was originally used as an effective treatment for glioblastoma. Due to positive results it is now in trials for NSCLC. Everything I've heard so far has been positive in that it is an easy treatment with little to no side effects excepting for those as a result of the concurrent chemotherapy that goes with it. 

Given the above, if I were a fit candidate for the trial I would seriously consider doing it myself. Basically, with proper care and supervision a person dosen't seem to come out any worse for wear and in my opinion there's a fair chance a trial participant could come out better than they went in. So, it's a better than fair trade off...  

You should hear from others about this as well...I have read quite a few others write about Novocure on these forums too.

[LexieCat]

I asked my oncologist (a top researcher--he's done presentations for Lungevity) about it, and he's skeptical. He says it's "interesting" but he pointed out that FDA approval for "devices" (which this is), has a much lower bar than, for instance, drugs. They primarily have to be "safe" as opposed to effective. He thinks the evidence it's effective for glioblastoma is convincing, but not for other cancers.

Saturn, I forget the details of your mom's cancer, but I'm dealing with progression after chemo and Keytruda, and am told there are literally hundreds of trials I'd be eligible for right now. There were three that immediately popped up in my immediate vicinity before I settled on the one I've chosen. I know this Novovcure trial is getting a lot of press right now, but that doesn't necessarily mean it's the most promising.

I found the trial I'm on mentioned here on the Lungevity forums, but I also ran it by Andrew from the Go2 Foundation to get his thoughts. Go2 can help locate clinical trials for which a patient might be eligible. Their main phone number for clinical trial info is 1-800-298-2436.

ETA: I just took a look at your previous posts. Didn't her oncologist say there were a few trials she had in mind? In addition to the one I'm doing, there were two others that my oncologist felt were promising that were going on at Penn: https://www.clinicaltrials.gov/ct2/show/NCT04495153 (that's the one I would have done if I weren't eligible for this one) and https://www.clinicaltrials.gov/ct2/show/NCT04452214. There are probably others, closer to where you are.

[LUNGevityKristin]

Just wanted to let you know of the LUNGevity Clinical Trial Finder and Ambassador programs.  It is free and they will help you find the trials that are best for you.

https://lungevity.org/for-patients-caregivers/lung-cancer-101/treatment-options/clinical-trials

[Saturn_Bound]

Awesome thanks everyone for your input. Yes @LexieCat, my mom's Oncologist did mention she would look at clinical trial options for her down the line. My concern is that by the time that happens, the cancer will be so progressed that she will not qualify.

From my understanding, the eligibility requirements for clinical trials can be quite strict, (no brain mets, etc.). Thankfully my mom has no brain mets (so far), but she needs to use supplemental oxygen a couple times a day, and she can only walk short distances across the house.

I guess I just feel like I want to take it into my own hands because I feel like we could be losing precious time. The onc did mention her hopes were that the chemo would keep her stable in the meantime, but I just want to be proactive in case there is a chance getting her on a trial sooner might help save her life.

 

[LexieCat]

The requirements for every clinical trial are different. For example, one trial I heard about REQUIRED that you have liver mets to be eligible. 

You can do as many clinical trials as you can find, and there won't necessarily be any delay. I could have started one of the other ones a week or two after we found the progression.

I'd contact Go2 and/or Lungevity (as suggested by Kristin)--they can tell you about any/all for which she'd be eligible right now.

 

[TJM]

13 hours ago, LexieCat said:

I asked my oncologist (a top researcher--he's done presentations for Lungevity) about it, and he's skeptical. He says it's "interesting" but he pointed out that FDA approval for "devices" (which this is), has a much lower bar than, for instance, drugs. They primarily have to be "safe" as opposed to effective. He thinks the evidence it's effective for glioblastoma is convincing, but not for other cancers.

Saturn, I forget the details of your mom's cancer, but I'm dealing with progression after chemo and Keytruda, and am told there are literally hundreds of trials I'd be eligible for right now. There were three that immediately popped up in my immediate vicinity before I settled on the one I've chosen. I know this Novovcure trial is getting a lot of press right now, but that doesn't necessarily mean it's the most promising.

I found the trial I'm on mentioned here on the Lungevity forums, but I also ran it by Andrew from the Go2 Foundation to get his thoughts. Go2 can help locate clinical trials for which a patient might be eligible. Their main phone number for clinical trial info is 1-800-298-2436.

ETA: I just took a look at your previous posts. Didn't her oncologist say there were a few trials she had in mind? In addition to the one I'm doing, there were two others that my oncologist felt were promising that were going on at Penn: https://www.clinicaltrials.gov/ct2/show/NCT04495153 (that's the one I would have done if I weren't eligible for this one) and https://www.clinicaltrials.gov/ct2/show/NCT04452214. There are probably others, closer to where you are.

Remember. It is a medical device not Chemo. Curious who would be the "Captain" if it works. Guessing not an oncologist?

Stock is sure acting like it is real...it is not a micro bio tech stock either. Trading at well over 200 dollars per share and 90% owned by institutions. I want it to work!

Peace

Tom

[LexieCat]

Well, supposedly they concurrently administer either immunotherapy (I forget which, maybe Opdivo?) or Docetaxel. So it's not JUST the device--it's one of those drugs along with.

[TJM]

3 hours ago, LexieCat said:

Well, supposedly they concurrently administer either immunotherapy (I forget which, maybe Opdivo?) or Docetaxel. So it's not JUST the device--it's one of those drugs along with.

It can be any second line treatment unless I read it wrong. Just another possible treatment, which is awesome....right?

[LexieCat]

6 hours ago, TJM said:

It can be any second line treatment unless I read it wrong. 

No, per the study description, patients are "[a]ssigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimens." Exclusion criteria include contraindications for receiving docetaxel and contraindications for immune checkpoint therapy. So apparently it's not a specific immunotherapy, but it does have to be either docetaxel or an immunotherapy drug.

Also, based on the description, patients in the study are randomized between the drug alone or the drug plus the device: 

• Eligible patients will be randomly assigned to one of two groups:
• Patients receive docetaxel or immune checkpoint inhibitor in combination with TTFields using the NovoTTF-100L System.
• Patients receive docetaxel or immune checkpoint inhibitor without TTFields. Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-100L group, the patients will be treated continuously with the device until disease progression in the thorax and/or liver according to RECIST or irRECIST (Immune-Related Response Evaluation Criteria In Solid Tumors) (depending if the patient is receiving docetaxel or immune checkpoint inhibitor, respectively).
• On both arms, patients who have disease progression according to RECIST or irRECIST (depending if the patient is receiving docetaxel or immune checkpoint inhibitor, respectively) will switch to a third line treatment according to local practice.

So there's no guarantee that you would be in the group that gets the device.

Just some additional details that may be relevant to deciding whether to participate in this study, versus another study or line of treatment.

 

[TJM]

Thanks. But they have basically stopped the trial because results were good. That's the news event. 

If you watch the interview of the CEO he goes much farther with possible uses than the trial above.

Peace

Tom

[Jesse L.]

If I recall the trial indications and preliminary results thereof, they stopped the study because it was working so good in regards to the patients using the device and Novocure was applying on an emergency basis to the FDA to make the device available to ALL trial participants. From what I read per FDA rules, that's just the way it's done. Now, I could be wrong about this and please if I am someone let me know. 

I remember in a post I wrote that it's about time researchers looked into all possible ways to fight this disease...especially those that come without debilitating side effects! I for one get tired of listening to drug commercials where the list of side effects is longer than a person's arm...twice as long in fact!!😦 😦😦😦

Maybe they found a magic bullet...if anything maybe a little one. I know it's alright to be skeptical but we got to have hope too!!