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In this exclusive 番茄社区app video, Karen Reckamp, MD, of Cedars-Sinai Medical Center in Los Angeles, discusses the study design of the innovative phase III trial (S2302) in metastatic non-small cell lung cancer (NSCLC).

Pragmatica-Lung was built on phase II findings from the that demonstrated that ramucirumab (Cyramza) and pembrolizumab (Keytruda) improved overall survival over standard of care for pretreated patients with metastatic NSCLC and resistance to checkpoint inhibition. The streamlined phase III trial allows for broader eligibility, reduced site burden, and increased patient representation.

Following is a transcript of her remarks:

We are performing a pragmatic study, which we call Pragmatica-Lung. This is S2302, run through the SWOG NCTN [National Clinical Trials Network] network. And this is a study that we started by doing a phase II randomized trial through our Lung-MAP platform, which is another study run through NCTN and SWOG. And in this study, we learned that ramucirumab and pembrolizumab had an improvement in overall survival, but it was in a phase II study with fewer patients than our standard phase III trials.

So with that improvement in overall survival and the collaborations that we had through Lung-Map with the FDA, with CTEP [Cancer Therapy Evaluation Program], with NCI [National Cancer Institute] and the cooperative groups and some of our private partnerships, we were able to take that data and think about how do we do a more streamlined phase III trial. And in today's day and age, we have a lot of complicated trials. Most of them are complicated trials in oncology. And we wanted to kind of rewrite how we do oncology trials.

So for specific scenarios like this where we have two drugs where they are approved in multiple tumor types, approved in lung cancer, we know the toxicities, we know what to expect, they don't have a lot of overlapping toxicities. And we had an outcome of overall survival that is very specific and doesn't require a lot of other assessments, because it is survival.

And with that, we moved forward and we stripped away a large majority of things like eligibility requirements for data collection and moved forward with a trial that makes it broader eligibility, more patients that can enter, reduce burden for our site staff. So a study that more people can do, more people can enter and more people can do, more sites can do, which gets to more representation on the trial.

It's a really novel way of moving forward. It's only a handful of trials that can be done this way, but other trials could think about doing some pragmatic aspects of their trial. Some properties that could be a little more broad, a little more inclusive.

And by doing this, we're saving money on the trial conduct. So we actually have a partner in a company called MMG who is helping us to go to sites, especially those with underrepresented groups that can increase accrual at those sites. And we have seen, we have a poster also on the patient recruitment, and we are seeing higher levels of Black participants in the trial. We're about 15% right now in our accrual, which is kind of unheard of for a randomized phase III trial. So we're really excited about how this might change the field for some trials.

And again, Pragmatica-Lung, we expect 700 patients in the trial. Today we were at 495 when I looked this morning, and we opened in March of 2023. So we're now accruing about 40 to 50 patients per month. And so we are making the strides and we're starting to see that what we set out to do with this, to be more inclusive, to have a rapid accrual phase III trial with minimal burden, is starting to work in the way that we planned it to. And next, we'll hopefully see some results on the outcome.

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