Lucanix Study Halted

I have been informed that the Lucanix study has been halted.
This can be good or bad, I don't know what right now other than it has been halted.

NovaRX is supposed to release data in January.

Anyone else know anything?

Hopefully Danram will see this and let us know if he knows anything.

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Roosty,
What do you mean "halted"?
Are those enrolled in the study not receiving their injections?
Annika

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Wow. I hope it's good news.
Toes

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I'm curious - who informed you?

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Halted could mean terminated, on hold or suspended.

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From my oncologist at UCLA:

"It’s true the study was stopped and they have asked that current patients be withdrawn from the study.
I don’t have any details as to why they terminated the study."

Either it was stopped for "efficacy" (it works) or it was stopped for "failure" (it has no clinical benefit).

Pins and needles time for all of us in the study or getting it via Compassionate Use.

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It will be declared on thursday

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Damn. This is such a disappointment.

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It could be positive. We just have to wait.

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If this is shut down due to lack of efficacy it sure would be a huge disappointment.
This scenario doesn't make sense though if Danram's reporting is true:

From Dec 28,2012

..."As of this past week, the median survival time for all of the patients in the Lucanix trial, including the placebo group, is between 18 and 19 months. To be fair, there is absolutely no way that we can know at this time whether or not the patients receiving Lucanix are faring any better than the patients receiving the placebo. For all we know, both groups have a median overall survival time of 18-19 months and there is no statistically significant difference at all between them."...

I will reserve a tiny bit of hope that it was stopped for "efficacy" (it works).


Annika

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How do you know it will be declared on Thursday?

Annika

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Further update from UCLA. Study halted due to futility (it doesn't work).

I am just in shock........

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Danran's always been a rather shadowy figure around here. Not a patient, don't know what he does, and the only connection he claims to Novarx is that he helped raise money for them. He has never specified that these are charitable donations or mentioned any organization, so I've always assumed he finds investors, and that they have a financial stake in the success of Lucanix. Hence, the always optimistic reports, even though the numbers he gives don't really back him up, as he himself admits.

If I remember correctly, he got reamed pretty good by a couple of Inspire members last time he posted, and he hasn't been back since. At least not that I can find.

I hate this so much, especially after the news about Stimuvax.

Toes

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InTheAir,

What's amazing and raises all kinds of questions to me on treatments is the fact you have remained NED.

Lucanix not being effective is very disappointing to say the least. I hope something is found out that it's effective for a subgroup.

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So sad to hear. My sis went for her Alimta infusion today and I was unable to go with her but I had faxed info on the Lucanix compassionate use to her onc as we were on the list to be reviewed once it started back up in Feb. Alimta has kept her stable for a year now so we continue with that.

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I am waiting for the final word from Novarx, It doesn't add up for me.

As for Danram, he really had nothing to gain by giving us information and it doesn't change anything. I find it hard to believe he made up those numbers so -again, I will wait and see what the news really are. It may be it works for certain subgroups.

Maybe I am grasping at straws but that is how I see it.

Why would they go through the expense of handing out Lucanix for CU if they had indications that it did not work? It is quite expensive.

Annika

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<<Why would they go through the expense of handing out Lucanix for CU if they had indications that it did not work?>>

If I remember correctly, early this month some Inspire members said NovaRx told them the Lucanix Compassionate Use program was on hold for the moment. The two events may be related.

I hope the trial was halted due to GOOD results.

I have an appointment with Dr. Camidge on Tuesday. I'll ask if he knows anything.

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I just now saw this.....unreal! I don't know what to think as you were halfway through your 18 months of injections and other people were receiving it CU. Both of our maintenance trials are halted but for some reason we are still NED. Now this makes me even more nervous wondering if there was anything at all to the vaccines that helped or not. We are both worry warts but I'm going to try to stay positive and hope that some aspect from these trials will be of use for something else in the near future.

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let's keep our fingers crossed for good news. Certainly there have been plently of reports from actual trial participants to give us hope. Next question ... Cost. I am guessing it will be comparable to Alimta @ $11,000 per infusion.

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Muchcamonstillhere (her screen name on Inspire) was on the Stimuvax vaccine. She has been NED for 4+ years now.

Stimuvax was also halted about a 4-6 weeks ago for "futility" but a couple days later the FDA and Stimuvax said they were studying some subgroups who took Stimuvax and had great results.

I think we will see the same with Lucanix. There are just too many people on Inspire who have had great results with Lucanix.

This is not over.

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I hope it was stopped because the data showed it worked well enough to be approved, and it was time to be unblinded. Did you guys know that only a 5% benefit when a drug is used with a placebo control is enough for FDA approval!!! And hard to understand a "futility" finding when so many enrolled were NED or Stable!!! unless the Inspire members reporting in were only outliers, and what's the odds of that?

In any case, if stopped due to "futility", this should open a potential US entrance to the Cuban CimaVax with 18 years of data from the Cubans and Phase III trials on-going in Great Britain and Sri Lanka against the Cuban data.

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