Pragmatica-Lung Closes, PROSPECT-Lung Opens

Also known as CTIU2317-A082304-S2402 (I’ll stick with “PROSPECT-Lung”), the trial is co-led by the Alliance and SWOG, with the Alliance heading up administration. Co-chaired by Drs. Daniel Morgensztern (Alliance) and Raid Aljumaily (SWOG), it compares perioperative systemic therapy to adjuvant systemic therapy in patients with resectable early-stage non-small cell lung cancer (NSCLC). You can learn more from this week’s press release or on the trial’s CTSU.org page.

It’s a highly pragmatic trial, in many ways a successor to the Pragmatica-Lung trial, incorporating some of the same elements that made that trial easy for sites to open and enroll to and which helped generate enthusiastic support.

It’s fortuitous, then, that PROSPECT-Lung opens just as Pragmatica-Lung is closing (I’d like to claim the alignment was due to careful planning, but no one could pull that off). 

Pragmatica-Lung (S2302) has crossed its accrual goal and will close December 20th, after what by all measures was an extremely successful run.

The trial’s initial target was 700 patients in 24 months. It was an ambitious goal, but the NCTN crushed it, completing enrollment in just 21 months, despite the fact we subsequently raised the accrual target from 700 to 800 (for greater statistical power and to add subgroup analyses). More than 700 sites opened the study, and almost 300 of those enrolled to it. 

The moral? If you build it (properly), they will come. Amazing interest, amazing accrual.

Pragmatica-Lung was intended from the start to serve as a model to learn from, and PROSPECT-Lung runs with some of those lessons, including its pragmatic design. On both arms, it relies on physicians to provide real-world care “according to the current standard of care at the time of enrollment,” using “regimens that align with NCCN guidelines or are FDA approved” (quotes from the protocol).

The trial also reflects the Pragmatica ethos in being highly streamlined, reducing the burden on both patients and sites, with a protocol of only 29 pages, just 13 case report forms, and minimal adverse event reporting requirements, among other efficiencies. 

These pragmatics and streamlined features should make it easier to open and enroll to the trial at sites large and small, academic and community-based, hopefully resulting in a group of 1,100 enrolled participants highly representative of the overall population of patients with early-stage NSCLC.

This is essential because PROSPECT-Lung tackles a major question in the treatment of these patients. We know adding immune checkpoint inhibitors to systemic therapy can benefit them, but we don’t yet have definitive evidence on the optimal timing for starting that therapy – before surgery or after? 

PROSPECT-Lung should give us that evidence, telling us which timing leads to better patient outcomes: perioperative treatment (starting before, continuing after) or adjuvant treatment? It’s a question unlikely to be addressed by industry-sponsored research, but it’s ideally suited to an NCI-sponsored study.

As we close the Pragmatica-Lung era, I extend profound thanks to all of the patients, healthcare providers, and staff who have made that trial so successful. And I say, welcome to the PROSPECT-Lung era!
 

Winter may be coming, but so is ASCO! ASCO’s abstract submission deadline for its annual meeting is January 28th. Per SWOG policy, however, abstracts are due to our Publications Office two weeks before that. So, if you plan to submit an abstract for ASCO 2025, please send it to pubs@swog.org, for vetting and processing, by January 14th, 2025.