Small Cell Lung Cancer Clinical Trials and DeLLphi Study Update

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Small Cell Lung Cancer Clinical Trials and DeLLphi Study Update from Patient Empowerment Network on Vimeo.

What value might small cell lung cancer (SCLC) clinical trial participation and the DeLLphi study offer patients? Expert Dr. Vinicius Ernani from the Mayo Clinic explains the significance of clinical trial participation and what is being studied in the DeLLphi trial for SCLC care.

[ACT]IVATION TIP

“…always ask your team about clinical trials. And again, I recommend patients, if it’s a reasonable clinical trial, I will always recommend my patients to be enrolled in it.”

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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials 

Transcript:

Lisa Hatfield:

Dr. Ernani, can you speak to the importance of expression of DLL3, what it is and what it means for small cell lung cancer research, and why is clinical trial participation so important in small cell lung cancer? And what advice do you have for patients who are considering a clinical trial?

Dr. Vinicius Ernani:

Yeah, so DLL3 is a protein expressed on the cancer cell of the majority of those patients with small cell lung cancer. And that’s where, exactly where tarlatamab, which is, it’s the BiTE, the T-cell engager that I mentioned before, that’s one of the targets. So the tarlatamab, it binds to the DLL3 on the surface of the cancer cell, and also bind to the CD3 at the T cell, right?

So that activation, the tarlatamab does that bridge and that activation enhances or activates the T cells to go there and fight the cancer. What we’ve seen in DeLLphi study with the tarlatamab is that the responses are irrespective of the DLL3 expression. But that being said, again, is the target of tarlatamab. And so it, again, it binds to the DLL3 the cancer cell, and it binds to the CD3 on the T cell.

And that activation enhances the T cell to fight against the cancer. Why is clinical trial participation so important in small cell? Well, I think I encourage all my patients to participate in clinical trials because some of the treatments that you can only get in clinical trials today, they might become the standard of care tomorrow.

Let’s say patients on immunotherapy five years ago, there are still some patients that are on trial, they’re still getting immunotherapy. And now, basically every disease you can treat the patients with immunotherapy. So you never know. The trial that you are enrolled in today might be the new standard of care tomorrow, and you might be having this chance to get it very early in the course of your disease.

So my activation tip for this question is, always ask your team about clinical trials. And again, I recommend patients, if it’s a reasonable clinical trial, I will always recommend my patients to be enrolled in it.

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Understanding Small Cell Lung Cancer Research News and Future Treatments

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Understanding Small Cell Lung Cancer Research News and Future Treatments from Patient Empowerment Network on Vimeo.

What do small cell lung cancer (SCLC) treatment and the future of treatment look like? Expert Dr. Vinicius Ernani from the Mayo Clinic discusses SCLC treatment progress and small cell lung cancer clinical trials including the DeLLphi trial.

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“I think stay tuned. This tarlatamab might become, down the road, a new standard of care for our patients.”

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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials 

Transcript:

Lisa Hatfield:

And, Dr. Ernani, can you please explain research advancements in immuno-oncology and what this means for extensive-stage small cell lung cancer patients? And how do you envision the treatment landscape evolving over the next five to 10 years? 

Dr. Vinicius Ernani:

Yes. So over the last 30 years, we’ve had multiple Phase II, Phase III trials and, unfortunately, we were not able to move the needle in small cell lung cancer. However, over the last few years with the advancement of immunotherapy and incorporating immunotherapy to the standard carboplatin (Paraplatin) and etoposide (Toposar), we were able to finally make some progress in small cell lung cancer.

So now we know that the standard of care is to give chemotherapy plus immunotherapy, and we have at least three to four randomized Phase III trials showing the benefit of adding immunotherapy to chemotherapy. And I think this is a very exciting time for small cell. We are seeing at least over the last couple of meetings, over the last year, I’ve been seeing at least two promising drugs.

 One is tarlatamab that was the Phase II studies called the DeLLphi trial, was recently presented at ESMO. And there’s also an antibody drug conjugate that has also been very promising in small cell. So we’ll see how these studies are going to play out, especially the antibody drug conjugate, that’s still a Phase I study. So it’s a little bit early, but encouraging response rates. And the tarlatamab, which is a BiTE, and what I mean by BiTE, is a bi T-cell specific engager. I think it’s probably going to be soon approved by the FDA, and I think it’s going to change the standard of care in small cell again.

 Lisa Hatfield:

Dr. Ernani, with regard to the DeLLphi trial, can you explain who that is for and more specifically maybe what the hope is for patients and their families?

Dr. Vinicius Ernani:

Yeah. So the DeLLphi trial was a Phase II study. So usually we have three types of study, right? First, we have the Phase I study. Phase I studies are usually looking at how safe is a drug, but we are not looking too much of how active the drug is. We’re just making sure that the drug is safe to give to the patients. A Phase II study is a little bit bigger than a Phase I, and we are looking still at safety, if the treatment is safe, but we are trying to look a little bit more careful and how active this drug is.

In Phase III, those are usually big studies that randomizes 200, 300, 400 patients to the standard of care compared to the new drug. And that’s usually where we get the FDA approvals. So the DeLLphi-301 trial was a Phase II study that enrolled patients with heavily pretreated small cell lung cancer, extensive stage small cell lung cancer, to receive tarlatamab.

 And they had two doses. It was 10 milligrams and 100 milligrams. And it seems that the 10 milligram cohort, that actually the responses were even better than the 100 milligrams. So we saw the presentation at ESMO, it was actually published in one of the most respected…probably the most respected journal of medicine, the New England Journal of Medicine, and there was a response rate of 40 percent. So if we could give tarlatamab for patients that fail at least two lines of treatment, the chances of them responding to tarlatamab is about 40 percent.

And more importantly, I think that the duration of response was greater than six months. So what I mean by that, more than 50 percent of the patients that received this drug, they controlled the cancer for at least six months. So I think that’s a very positive about this drug.

Lisa Hatfield:

Great, thank you. And then one follow-up question I have about that. So if a patient were to come to you or go to their local oncologist and say, I’m really interested, I heard about this DeLLphi trial or any clinical trial, what is the advice you would give to that patient on how to access that clinical trial?

Dr. Vinicius Ernani:

Well, unfortunately, we don’t have at our institution, what I usually help my patients,  I go to clinicaltrials.gov and I type their cancer, and I go over with them on where the trials are open, and we try to find a facility or a cancer center that is close to where they live. So that’s what I usually do when I’m trying to find a clinical trial that I don’t have available in my site.

My activation tip for this question is, again, I think stay tuned. This tarlatamab might become, down the road, a new standard of care for our patients.

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Starting Time-Sensitive Small Cell Lung Cancer Treatment

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Starting Time-Sensitive Small Cell Lung Cancer Treatment from Patient Empowerment Network on Vimeo.

Some small cell lung cancer (SCLC) treatment calls for time-sensitive treatment. Expert Dr. Vinicius Ernani from the Mayo Clinic shares how he works with patients who will most likely have optimal results with prompt treatment and advice for patients considering rapid treatment.

[ACT]IVATION TIP

“…at least give the treatment a try. I think that you’re going to be positively surprised that you’re going to feel better within a few weeks.”

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Transcript:

Lisa Hatfield:

Dr. Ernani, for some small cell lung cancer patients, understanding treatment options is crucial and sometimes requires swift decisions. How do you work with your patients and families to make treatment decisions that might have to be made rather rapidly? 

Dr. Vinicius Ernani:

Well, small cell, as we know, it’s an aggressive type of cancer, it divides very quickly. And because of that the patients usually, they tend to be symptomatic, so they have a lot of symptoms at the time that we see them. And if this disease, if we left untreated and the patient has extensive stage, so the disease has spread, the prognosis can be poor.

That being said, because small cell divides very quickly, chemotherapy combined with immunotherapy can help these patients fairly quickly. We can see patients in a matter of two to three weeks, they report that their shortness of breath is much better, they’re feeling better, they’re more energetic, they can do more things at home.

So we can see a rapid positive response to treatment very quickly. So when I explain this to my patients, most of the patients, they have no hesitation to say, yeah, I want to proceed with chemotherapy. And I tell them chemotherapy will help you feel better and also help you survive longer. And we are very fortunate that sometimes the patients are able to live years, they’re able to meet some live, let’s say, like a wedding of a grandkid or important events in their life. So I always recommend them to at least give it a shot.

My activation tip for this question is at least give the treatment a try. I think that you’re going to be positively surprised that you’re going to feel better within a few weeks.

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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials

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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials from Patient Empowerment Network on Vimeo.

What’s vital for small cell lung cancer (SCLC) patients to know about clinical trials? Dr. Rafael Santana-Davila with the University of Washington School of Medicine explains the impact of clinical trial on treatment advancements and questions for patients to ask when considering clinical trial participation. 

[ACT]IVATION TIP

“…if you’re considering a clinical trial, to make sure you read that consent. And that consent can be difficult sometimes. So if you have questions, just ask. When patients are on clinical trials, there’s a whole team of people that are looking for that patient. So ask the questions that you may have from that consent with that patient.”

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Key Resources for Small Cell Lung Cancer Patients and Families

Transcript:

Lisa Hatfield:

Why is clinical trial participation so important in small cell lung cancer? And what advice do you have for patients considering one?

Rafael Santana-Davila:

So clinical trials are very important, not only in small cell lung cancer, but in all cancers. The only way that we know how to treat this is by doing clinical trials. That is what moves the needle forward. It’s thanks to patients that participate in clinical trials that we know whether something worked or how much worked or something did not work, and we need to either get back to the drawing board or eliminate that possibility and move on.

Unfortunately, only the minority of patients participate in clinical trials and that is many times only because of access. So it’s important for patients to consider clinical trials. That is where we’re analyzing the future medications, and many of those future medications will become the standard of care and by participating in clinical trials, patients will have access to those medications.

And by participating in clinical trials, patients are also paying it forward. These clinical trials may not help them as much as possible, but they are helping those patients down the line. When patients are considering a clinical trial, there’s many questions that they need to ask is, “What does that involve for me? How frequently do I need to come to the cancer center? Aside from getting it, what else is asked from me? Am I being asked to also come to other blood draws, for example, or am I just receiving this treatment and that’s treatment by itself? Is there a randomized component to this clinical trial? Am I being elected to receive one arm or the other? Is there a placebo component in that trial?” The majority of patients with the majority of trials in cancer are not placebo-based.

But that’s important to know. “What help can the clinical trial give me?” Again, like we talked about, many clinical trials can help patients with lodging or transportation. So the activation tip for that is, if you’re considering a clinical trial, to make sure you read that consent. And that consent can be difficult sometimes.

So if you have questions, just ask. When patients are on clinical trials, there’s a whole team of people that are looking for that patient. So ask the questions that you may have from that consent with that patient. And I always encourage a clinical trial because again, that is what is helping us move the needle forward. 

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Small Cell Lung Cancer | Hope for Treatment Advancements

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Small Cell Lung Cancer | Hope for Treatment Advancements from Patient Empowerment Network on Vimeo.

What does the future of small cell lung cancer (SCLC) treatment look like? Dr. Rafael Santana-Davila with the University of Washington School of Medicine explains advances in SCLC research, treatments that are in clinical trials, and questions to ask about clinical trial access.

[ACT]IVATION TIP

…you need to ask the doctors, “Are there any clinical trials that you’re excited about that I should look into right now? Where are they available? And can I participate in that?”

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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials

Transcript:

Lisa Hatfield:

Often, SCLC patients feel like there’s so much information coming out about non-small cell lung cancer, but feel left out of these conversations. Can you share why small cell lung cancer patients should be hopeful for more conversations around advancements in the future?

Dr. Rafael Santana-Davila:

So that is a very important question, subject. And that is true. We see a lot of advances in non-small cell lung cancer and not that much in small cell lung cancer. I frequently say that small cell lung cancer is the bad brother, the black sheep that we don’t talk about. Part of that is because small cell lung cancer is just a more aggressive cancer, but part of that is it has not been studied as much as non-small cell. Non-small cell lung cancer is also a hodgepodge of diseases, and there are a variety of diseases that are nested into that category, so it’s natural to have more advances in that because there are more diseases. But I can tell patients that we’re making headways in small cell lung cancer.

We’re making headways in identifying those patients that we need to escalate therapy, we’re identifying novel treatments. There are different things in the pipeline that range from other methods of immuno-oncology, like complicated names like BiTE therapies or antibody drug conjugates that are coming out. There are a lot of epigenetic therapies that are coming out. So although it’s true that patients with non-small cell lung cancer have had more advances, there is still a lot of hope for the future. And what I can tell you it’s changing rapidly. And in a year, the treatments that we may have available will be different. And all those things are right now going into clinical trials. So that’s why the activation tip for that is you need to ask the doctors, “Are there any clinical trials that you’re excited about that I should look into right now? Where are they available? And can I participate in that?”

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Small Cell Lung Cancer and Immuno-Oncology | What Patients Need to Know

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Small Cell Lung Cancer and Immuno-Oncology | What Patients Need to Know from Patient Empowerment Network on Vimeo.

What do immuno-oncology advancements mean for limited stage and extensive stage small cell lung cancer (SCLC)? Dr. Rafael Santana-Davila with the University of Washington School of Medicine explains the research advancements in immuno-oncology and the status of these treatments and clinical trials for LS-SCLC and ES-SCLC patients.

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“…patients who are diagnosed with small cell lung cancer should ask a doctor, ‘What about immunotherapy? Is that the right thing for me?’”

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Key Resources for Small Cell Lung Cancer Patients and Families

Transcript:

Lisa Hatfield:

Could you please explain research advancements in immuno-oncology and what this means for limited and extensive stage small cell lung cancer patients? And which patients have access to that?

Rafael Santana-Davila:

So, immuno-oncology is something that has completely changed the paradigm of treatment of patients with cancer, and very rough explanation, very simple is treatment that augments a patient’s own immune system so the immune system can recognize the cancer. This has changed dramatically how we, treat many cancers and many cancers, or sorry, many patients, when this is successful, can have very long survivals thanks to development of immunotherapy.

So, a few years ago, there were clinical trials that showed that the addition of PD-L1 inhibitors, which are a type of immunotherapy added to chemotherapy can both extend the duration of what we call progression-free survival, which is the amount of time before the cancer grows, as well as overall survival, which is obviously how long a patient lives.

But the addition of these medications can extend both of these numbers and is helping patients live longer. This was an extensive stage. So today there are two drugs that are approved by the FDA to add to the addition of chemotherapy. There are atezolizumab (Tecentriq), and durvalumab (Imfinzi). They are, in our eyes, equal.  One is not better than the other. And they are added to chemotherapy. Chemotherapy is continued for, in the majority of cases, for four cycles, and then patients go on to receive immunotherapy by itself. This is an extensive stage lung cancer. A limited stage lung cancer, there are current clinical trials that are asking the question of whether these medications are also worth it, do they improve things?

We do not know the answer to that question as of today. We are also very hopeful that they do, but we’re waiting for the results of those clinical trials. So which patients have access to it today is those patients that have extensive stage disease and that is the standard of care. So an activation tip for this is patients who are diagnosed with small cell lung cancer should ask a doctor, “What about immunotherapy? Is that the right thing for me?”

And in the great majority of extensive stage disease, they will be eligible for unless there are contraindications. Some very main contraindications is a history of autoimmune diseases or patients that are in immunosuppressive drugs, but that is a minority of patients.

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What Treatment Options Are Available for Small Cell Lung Cancer?

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What Treatment Options Are Available for Small Cell Lung Cancer? from Patient Empowerment Network on Vimeo.

What do extensive stage small cell lung cancer (SCLC) and limited stage SCLC patients need to know about treatments? Dr. Rafael Santana-Davila with the University of Washington School of Medicine shares a status update on where treatment options stand and discusses how he works with patients on treatment decisions.

[ACT]IVATION TIP

“…patients need to make sure that they know what the goals are. ‘What is…where am I going to…how am I going to feel in the next month? What is the likelihood that this cancer is going to shrink and this cancer is going to make me live longer?’”

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Small Cell Lung Cancer | Hope for Treatment Advancements

Transcript:

Lisa Hatfield:

So what is the latest information related to treatment options for limited stage LS and extensive stage ES small cell lung cancer? And how do you work with your patients to make treatment decisions about that?

Rafael Santana-Davila:

So this is, unfortunately, a disease where little progress has been made throughout the years because it’s a very aggressive disease. And the main improvement that has been made in the last five years is the addition of immunotherapy to chemotherapy in patients with extensive stage disease. There have now been several clinical trials that have shown that adding immunotherapy improves overall survival. That means that patients live longer.

And there is a very small, but a few patients that have, that see survival into the many years, which is something that was unthinkable before the era of immunotherapy. We do not know if the addition of immunotherapy to limited stage disease, which treatment is, in the majority of cases, chemotherapy and radiation, we do not know if that works or not, that there are clinical trials that are going on, most of them have completed accrual, so we’re just waiting for the data to mature to let us know if that is something that also works there.

We have a lot of hope that it’s the case, but right now, in September 2023, we do not know the answer for that. What I work…how I work with patients to make treatment decisions is I present them with the options of the treatment. So there are always options from being as aggressive as we can to treat it, to try to shrink the cancer, which, many times, comes at the price of side effects to just doing best supportive care, which is we know that sometimes shrinking the cancer is not what is going to make people live longer.

So it’s a conversation that we constantly have with patients where we say, “This is what we propose, this is what the consequences of treatment is going to be, and these are the alternatives.” And you have to work with them depending on their goals, depending on what they want to achieve, you make treatment decisions.

Ultimately, what I tell my patients is, “You’re the captain of the ship. I’m here just to help you navigate these rough waters, but, ultimately, you’re the one that needs to tell me where we want to go.” Okay. An activation tip is patients need to make sure that they know what the goals are. “What is…where am I going to…how am I going to feel in the next month? What is the likelihood that this cancer is going to shrink and this cancer is going to make me live longer?” Those are the questions that they need to make sure they understand.

And something that also they want to know is, what are the goals? It’s very different when you see a very young patient, their goal is to see their high school kid enter college than a 90-year-old patient that their goal is maybe to live the rest of their life with the least intervention or with the least side effects possible. So every patient has different goals. 

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